Remifentanil Versus Rocuronium for Optimizing Video Laryngoscopy-assisted Tracheal Intubation in Patients Undergoing General Anaesthesia - a Multicentre Randomised Controlled Trial -The ROCVIDEO Trial

Globally, we are approaching 1 million surgical procedures each day. Tracheal intubation is the mainstay of securing the patient's airway and breathing during general anaesthesia. Approximately 100.000 tracheal intubations are performed annually in Denmark. Airway management remains the primary reason for anaesthesia-related morbidity and mortality. It has been traditionally accepted that best tracheal intubation conditions are obtained by paralysing the patient's muscles, including vocal cords, using a neuromuscular blocking agent (NMBA) such as rocuronium. However, using NBMA may increase the risk of pulmonary complications, intra-operative awareness, in which the patient is paralysed but awake during surgery, anaphylaxis, and re-intubation. In addition, there is a risk of residual neuromuscular blockade postoperatively. In the US, prolonged ventilation and unplanned intubation are the top two most costly perioperative complications. An alternative to NMBA is a large dose of opioids to depress laryngeal reflexes during intubation. The most commonly used non-NMBA modality includes bolus administration of remifentanil. However, remifentanil may cause bradycardia and hypotension. Even short periods of hypotension have been shown to increase the risk of myocardial injury and other serious adverse events such as renal failure, delirium, and even mortality.
Evidence also indicates that intubation conditions using only opioids to facilitate intubation, including remifentanil, are inferior to NMBA. However, these trials are underpowered to assess effects on patient-important outcomes and are mostly at high risk of bias. A recent trial has suggested that remifentanil intubation conditions may not be very different. Almost all existing research comparing NMBA to opioids has focused on intubation conditions for direct laryngoscopy using a conventional Macintosh laryngoscopy blade. In recent years, the implementation and availability of the video laryngoscope have grown exponentially and become universal. The video laryngoscope has vastly improved the ease of tracheal intubation, and the number of failed intubations has decreased by two-thirds in Denmark, where a rapid implementation of the video laryngoscope took place. However, limited evidence exists on whether NMBA improves intubation conditions compared to remifentanil when performing video laryngoscope-assisted tracheal intubation.

Start Date01 Jun 2025

Sponsor / Collaborator-

ChiCTR2500098772

/ SuspendedPhase 4IIT

Comparison of efficacy and safety of Afentanil, oxelidine fumarate, Sufentanil combined with etomidate and propofol in painless gastroscopy

Start Date15 Apr 2025

Sponsor / Collaborator-

NCT06810843

/ Not yet recruitingNot ApplicableIIT

Sedation of Remazolam in Combination With Afentanil in Non-intubated Thoracoscopic Pulmonary Surgery: a Single-blind, Randomized, Controlled Trial

Non-intubated Thoracoscopic surgery (NITS) is a newly emerging minimally invasive surgical technique in recent years . Compared with traditional intubation general anesthesia, it has the advantages of less trauma, faster recovery and fewer complications . This surgical method allows patients to perform under local anesthesia or regional block and moderate sedation, providing a physiologic ventilation method , reducing the intervention on the respiratory system and conducive to rapid postoperative recovery.
The importance of sedative drugs in non-intubated thoracoscopic surgery Successful implementation of non-intubated thoracoscopic surgery requires sound regional block, airway management, and rational use of intravenous sedation and analgesics . In addition, sedative drugs need to have less respiratory and circulatory inhibition and fewer side effects. Propofol, as the most commonly used sedative drug, has a high incidence of adverse reactions such as injection pain and respiratory and circulatory inhibition. A large number of meta-analyses and systematic reviews have compared the sedative effects of remazolam and propofol, proving that Remazolam, as a new sedative, has advantages such as short half-life, rapid onset, rapid recovery, and light respiratory and circulatory inhibition.Compared with traditional benzodiazepines, Remazolam has a shorter half-life, which is conducive to rapid postoperative wakeup and reduces the risk of discomfort and cognitive dysfunction in patients. In addition, remazolam has little influence on the respiratory system and is relatively stable on the circulatory system ，which is an ideal sedation option for non-intubated thoracoscopic surgery that retains spontaneous respiration. Afentanil mainly acts on μ opioid receptors , and its analgesic intensity is about 15 times that of morphine, which has the advantages of rapid onset, short duration of action, rapid recovery, high safety, and few adverse reactions . Afentanil has a short half-life , mild respiratory depression, low incidence of cough, postoperative nausea and vomiting . Remazolam combined with afentanil is widely used in various surgeries or examinations that preserve spontaneous breathing, such as gastroenteroscopy, ERCP, hysteroscopy, short-term plastic surgery and fiberbronchoscopy, and has shown the advantage of light respiratory circulation inhibition . We speculate that remazolam combined with afentanil may have certain advantages in non-intubated thoracoscopic surgery that retains spontaneous breathing. At present, the application of remazolam combined with afentanil in non-intubated thoracoscopic surgery is still lacking. The purpose of this study was to observe the safety and effectiveness of remazolam combined with afentanil in non-intubated thoracoscopic surgery, and to provide a better choice of sedation drugs for non-intubated thoracoscopic surgery.

Start Date01 Apr 2025

Sponsor / Collaborator

Qianfoshan Hospital of Shandong Province

100 Clinical Results associated with Remifentanil Hydrochloride

100 Translational Medicine associated with Remifentanil Hydrochloride

100 Patents (Medical) associated with Remifentanil Hydrochloride

9,383

Literatures (Medical) associated with Remifentanil Hydrochloride

01 Jun 2025·Intensive and Critical Care Nursing

The comparison of pupillometry to standard clinical practice for pain and preemptive analgesia before endotracheal suctioning: A randomized controlled trial

Article

Author: Perez-Francisco, Ines ; Vallejo-De-la-Cueva, Ana ; López-de-Audícana-Jimenez-de-Aberasturi, Yolanda ; Bermudez-Ampudia, Cristina ; Parraza-Diez, Naiara ; Bengoetxea-Ibarrondo, Miren Begoña

BACKGROUND:

Pain during endotracheal aspiration (ETA) is frequent in critically ill patients. Managing pre-emptive analgesia before procedures remains a crucial aspect of care. We compared pupillometry to standard clinical practice for assessing preemptive-analgesia administration and pain before ETA according to Behavioural Pain Scale (BPS), the Behavioural Pain Indicator Scale (ESCID), and the Pupillary Dilation Reflex (PDR).

TRIAL DESIGN:

A multicentre parallel-group, controlled trial with balanced (1:1) randomization.

METHODS:

Sedated, mechanically ventilated patients aged ≥ 18 with baseline BPS = 3, ESCID = 1, and RASS scores between -1 and -4 were included.

CONTROL GROUP:

preemptive-analgesia was administered according to nurse criteria. In the experimental group, preemptive analgesia was administered in patients with PDR ≥ 11.5 % after a 20 mA stimulus measured using AlgiScan®. The preemptive analgesia was fentanyl one µg/kg iv bolus. We used the Chi-square statistic to compare post-intervention pain according to BPS, ESCID, and PDR pain values. A multivariate logistic regression study adjusting for sex, BIS, RASS, APACHE II, remifentanil, and preemptive analgesia was conducted.

RESULTS:

Ninety-two patients were studied, 51 in control groups and 41 in intervention groups. Pain incidence was lower in the experimental group. Significantly, 43.9 % of patients in the experimental group were prescribed preemptive analgesia before ETA compared to 19.6 % in the control group (p = 0.03). Multivariate analysis showed significant reductions in pain in the group that received preemptive-analgesia before ETA guided by pupillometry across BPS [OR = 0.34 (95 % CI: 0.12-0.99), p = 0.048], ESCID [OR = 0.29 (95 % CI: 0.09-0.88), p = 0.030] and PDR [OR = 0.27 (95 % IC: 0.08-0.86), p = 0.027] compared to standard clinical practice.

CONCLUSIONS:

Preemptive analgesia monitored with pupillometry group had a lower percentage of patients with pain than those who received analgesia based on standard clinical practice. This effect was independent of the sex, patient severity, BIS score, remifentanil use, or preemptive- analgesia.

IMPLICATIONS FOR CLINICAL PRACTICE:

The requirement for preemptive analgesia before aspiration, evaluated through routine clinical practice, was lower than detected by pupillometric monitoring of patients. The use of pupillometry to monitor preemptive analgesia reduced pain after secretion aspiration. Pupillometry would be an effective tool to individualize the need for preemptive analgesia before potentially painful interventions, applicable to all patients regardless of sex, severity, or sedation level.

01 Apr 2025·JOURNAL OF ARTHROPLASTY

Ultrasound-Guided Erector Spinae Plane Block in Elderly Patients Undergoing Total Hip Arthroplasty: A Triple-Blind, Randomized Controlled Trial

Article

Author: Wu, Xin-wei ; Li, Qi ; Wu, Xin-Wei ; Zhou, Hong-Mei ; Zhou, Hong-mei ; Zhang, Liang

BACKGROUND:

Total hip arthroplasty (THA) induces postoperative pain in elderly individuals. The erector spinae plane block (ESPB) is a novel analgesic approach for postoperative pain control. This randomized controlled trial evaluated the effectiveness of ultrasound-guided ESPB with ropivacaine in reducing pain in elderly patients undergoing THA.

METHODS:

Patients aged 60 to 80 years who had an American society of Anesthesiologists physical statuses I to III were eligible for this study. There were 50 patients who were randomized into two groups: the ESPB group receiving ultrasound-guided ESPB with ropivacaine, and the control group receiving ESPB with normal saline. All patients underwent general anesthesia, and the mean arterial pressure (MAP) heart rate (HR) intraoperative opioid consumption, numerical rating scale (NRS)scores, and postoperative adverse reactions were recorded throughout the perioperative period.

RESULTS:

A significant reduction in NRS scores was observed in the ESPB group compared to the control group at various time points, including in the recovery room and at 12 and 24 hours postoperatively (P < 0.05). When the observation period was extended to 48 hours, no significant difference in NRS scores was noted between the two groups (P > 0.05). No significant differences in MAP and HR were found between the two groups, but the ESPB group showed lower coefficients of variation for both MAP and HR. Moreover, the ESPB group demonstrated significantly lower total remifentanil consumption than the control group. There was no significant difference in complications between these two groups (P < 0.05).

CONCLUSIONS:

Ultrasound-guided ESPB enhances the perioperative stability of MAP and HR, providing effective analgesia within the initial 24 hours postsurgery, thereby reducing opioid requirements and improving overall postoperative recovery quality for elderly THA patients.

01 Apr 2025·ANESTHESIOLOGY

TAK-925 (Danavorexton), an Orexin Receptor 2 Agonist, Reduces Opioid-induced Respiratory Depression and Sedation without Affecting Analgesia in Healthy Men

Article

Author: van Lemmen, Maarten ; van Velzen, Monique ; Jansen, Simone C. ; Lu, Hong ; Meyer, Seetha ; Wu, Rebecca L. ; Tolkoff, Max ; Naylor, Melissa ; von Rosenstiel, Philipp ; Hang, Yaming ; Dahan, Albert ; Sheikh, Sarah ; Sullivan, Danielle ; Olsson, Tina ; van der Schrier, Rutger

Background::

Orexin neuropeptides help regulate sleep/wake states, respiration, and pain. However, their potential role in regulating breathing, particularly in perioperative settings, is not well understood. TAK-925 (danavorexton), a novel orexin receptor 2–selective agonist, directly activates neurons associated with respiratory control in the brain and improves respiratory parameters in rodents undergoing fentanyl-induced sedation. This study assessed the safety and effect of danavorexton on ventilation in healthy men in an established remifentanil-induced respiratory depression model.

Methods::

This single-center, double-blind, placebo-controlled, two-way crossover, phase 1 trial randomized (1:1) 13 healthy men to danavorexton (11 mg [low-dose], then 19 mg [high-dose]) or placebo, under remifentanil infusion, on two occasions separated by a 36-h or longer washout period. Remifentanil infusion was titrated under isohypercapnic conditions to achieve an approximately 30 to 40% decrease in minute ventilation (from approximately 20 to approximately 14 l/min) before danavorexton/placebo administration. Assessments included safety, ventilation measurements, sedation, and pain tolerance.

Results::

A total of four (30.8%) danavorexton-treated participants and one (8.3%) placebo-treated participant experienced treatment-emergent adverse events (all mild in severity). Insomnia, lasting 1 day, occurred in one participant, and was considered related to danavorexton. Compared with placebo, low- and high-dose danavorexton significantly increased ventilation variables (observed mean [95% CI] change, sensitivity analysis model-based P values) including minute volume (8.2 [95% CI, 5.0 to 11.4] and 13.0 [95% CI, 9.4 to 16.5] l/min), tidal volume (312 [95% CI, 180 to 443] and 483 [95% CI, 309 to 657] ml), and respiratory rate (3.8 [95% CI, 1.9 to 5.7] and 5.2 [95% CI, 2.7 to 7.7] breaths/min; all P < 0.001). High-dose danavorexton significantly decreased sedation on a visual analog scale (–29.7 [95% CI, –54.1 to –5.3] mm; P < 0.001) and the Richmond Agitation Sedation Scale (0.4 [95% CI, 0.0 to 0.7]; P < 0.001) compared with placebo. Improvements in respiratory variables continued beyond completion of danavorexton infusion. No significant differences in pain tolerance were observed between danavorexton doses or between danavorexton and placebo (approximately 13% increase from baseline; low dose, P = 0.491; high dose, P = 0.140).

Conclusions::

Danavorexton has effects on respiration and wakefulness in an opioid-induced respiratory depression setting without reversing opioid analgesia.

News (Medical) associated with Remifentanil Hydrochloride

14 Mar 2025

·www.echemi.com

5 Key Updates on China's Fentanyl Control Amid US Tariffs

On February 1st, the United States announced a 10% tariff on products imported from China, citing concerns over the fentanyl crisis. In response, a spokesperson from the Ministry of Public Security emphasized that China maintains one of the strictest drug control policies in the world. As a signatory to the three UN drug control conventions, China has consistently upheld its international obligations and actively collaborates with countries, including the US, on drug enforcement efforts. In 2019, China took a humanitarian step by becoming the first country to classify all fentanyl-related substances under stringent controls, responding to US requests. Since this classification, China has not received reports of these substances being seized in the US. On March 12th, the National Medical Products Administration (NMPA) shared insights regarding China's management of fentanyl substances through a recently released white paper. The spokesperson addressed concerns about the production and export of fentanyl-related pharmaceuticals. Currently, four fentanyl-related drugs are approved for clinical use in China: fentanyl, sufentanil, remifentanil, and alfentanil. Three companies have been authorized to produce raw materials, while five are permitted to manufacture formulations. In 2024, China produced 100 kilograms of fentanyl raw materials, primarily for domestic medical use and export, with only 12.3 kilograms exported to countries like South Korea, Vietnam, and the Philippines. Notably, China has never exported fentanyl products to North America. All fentanyl-related drugs in China are classified as controlled narcotics, subjected to stringent regulations. The production and distribution of these drugs are closely monitored, with specific companies designated for manufacturing and fixed sales channels established. Export controls require permits, and international verification ensures the legality of trade before issuing export licenses. The NMPA will continue to enhance the supervision of fentanyl-related drug production and strictly regulate exports to prevent illegal channels and misuse, ensuring that medical needs are met responsibly.

Drug Approval

06 Mar 2025

·www.drugs.com

Intraoperative Remifentanil, Sufentanil Tied to Poor Postoperative Pain Experience

THURSDAY, March 6, 2025 -- For patients undergoing elective surgery , intraoperative use of remifentanil and sufentanil is independently associated with a poorer postoperative pain experience, according to a study published online Feb. 25 in Regional Anesthesia & Pain Medicine . Axel Maurice-Szamburski, M.D., Ph.D., from the University Hospital Centre Nice Pasteur Hospital in France, and colleagues conducted an exploratory secondary analysis using data from 971 adults undergoing elective surgery under general anesthesia across five hospitals to identify factors associated with poor postoperative pain experience. Patient experience measured by the Evaluation du Vécu de l'Anesthésie Generale questionnaire on postoperative day 1 was the primary end point. The researchers found that 27.9 percent of patients reported poor pain experience. Intraoperative use of remifentanil and sufentanil was identified as an independent predictor of poor pain experience in a multivariate analysis. Age, absence of premedication, and orthopedic surgery were associated with a significantly lower likelihood of poor pain experience. In contrast, predictors of poor pain experience included American Society of Anesthesiologists 3 status, postoperative anxiolytic use, amnesia, higher visual analog scale pain, and lower well-being scores on day 1. "These findings underscore the need to reassess intraoperative analgesic strategies to reduce postoperative complications and improve patient care," the authors write. "Further research is required to confirm these associations and to develop optimized perioperative pain management protocols focused on enhancing patient outcomes."

Clinical Result

27 Feb 2025

·www.drugs.com

Opioids During Surgery Might Cause Worse Pain For Patients

THURSDAY, Feb. 27, 2025 -- Powerful synthetic opioids are meant to serve as painkillers, but new research suggests their use during surgery might actually prompt worse pain during patients’ recovery. The use of two types of synthetic opioid during surgery is linked to patients having a poor “pain experience” -- a composite of the emotional, cognitive and mental aspects of pain, researchers said. In fact, the use of remifentanil and sufentanil during surgery increased 27-fold a patient’s risk of suffering as they recover, researchers reported Feb. 25 in the journal Regional Anesthesia & Pain Medicine . While opioid drugs can help quell pain following surgery, “their intraoperative administration -- especially of potent agents like remifentanil and sufentanil -- may paradoxically contribute to heightened postoperative pain,” concluded the research team led by Dr. Axel Maurice Szamburski , an associate professor of anesthesiology with the University Hospital Center Nice Pasteur Hospital in Nice, France. Most patients experience moderate to severe pain following surgery, researchers said in background notes. This isn’t just unpleasant for them, but can hinder their recovery and increase their risk of complications. “Identifying key determinants of a poor pain experience could help uncover areas of care that, when addressed, may improve patient satisfaction and reduce the risks of both acute and chronic postsurgical pain,” researchers wrote. For this study, researchers analyzed data gathered for 971 patients as part of a clinical trial aimed at evaluating the effectiveness of sedatives given prior to surgery. The patients, all younger than 70, had been randomly assigned the day before surgery to receive the sedative lorazepam , a placebo, or nothing at all. Their surgeries took place at five French teaching hospitals. About 37% of the surgeries were orthopedic or spinal; 29% involved the ear, nose or throat; and 15% digestive, the study says. Of those patients, 271 (28%) reported a poor pain experience on their first day following surgery, based on a questionnaire aimed at capturing all the mental and physical aspects of pain. The use of powerful opioids while patients were under general anesthesia increased their risk of pain during recovery by about 27 times, researchers found. This is consistent with a known phenomenon called “opioid-induced hyperalgesia, where exposure to a high dose of opioids can lead to an increased sensitivity to pain stimuli,” researchers wrote. Patients also were five times more likely to have serious pain if they have a severe chronic illness, and eight times more likely if they were given drugs following surgery to treat anxiety, results show. People were 51% less likely to have pain if they were given no preoperative sedatives, and 71% less likely if they had undergone orthopedic surgery. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical Result

100 Deals associated with Remifentanil Hydrochloride

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KEGG	Wiki	ATC	Drug Bank
D01177	Remifentanil Hydrochloride	N01AH06	DB00899

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Pain	Switzerland	GSK Plc	28 Jan 1997
Anesthesia	United States	Mylan Institutional LLC	12 Jul 1996

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Analgesia	Phase 3	Germany	GSK Plc	01 Nov 2006
Sedation	Phase 3	Germany	GSK Plc	01 Nov 2006
Hyperalgesia	Phase 1	Germany	Air Liquide Santé (International) SA	01 Jan 2012

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02898792 (Pubmed \| Br J Anaesth)	Early Phase 1	Sleep Apnea, Obstructive	-	remifentanil (Adult volunteers without OSA)	ttaqbnmiqg(sfrryzqkyc) = luaotldxft nmpllfjkky (loikdxxsoa ) View more	Positive	01 Mar 2025
				remifentanil (Adult volunteers with untreated OSA)	ttaqbnmiqg(sfrryzqkyc) = gefzmychuf nmpllfjkky (loikdxxsoa ) View more
NCT04734418 (Pubmed \| J Intensive Care) Manual	Not Applicable	-	179	Remifentanil	fkrinzhcya(gupuzidaes) = umnygtkojc pijsdgomux (hiijjhpfiv ) View more	Negative	18 Sep 2024
				Dexmedetomidine	fkrinzhcya(gupuzidaes) = suygyrbzpb pijsdgomux (hiijjhpfiv ) View more
NCT02631135 (CTgov)	Phase 4	-	40	Propofol+Rocuronium+Remifentanil (Group 1 (TIVA))	fkzdasnxot(lqcbgfxhfz) = sdhcifnxgs uywmjbbixm (ptdbpdjoye, 1.31) View more	-	17 May 2024
				Dexmedetomidine+Propofol+Rocuronium+Remifentanil (Group 2 (TIVA+D))	fkzdasnxot(lqcbgfxhfz) = ttvakeugib uywmjbbixm (ptdbpdjoye, 1.19) View more
NCT03207100 (Pubmed) Manual	Not Applicable	Cerebral Hemorrhage	338	remifentanil grdexmedetomidineil and dexmedetomidine)	wvmcbydfsr(shfracyhvf) = pjyytttdqb hizazjdhrf (zeftihhavb )	Positive	27 Mar 2024
				remifentanil (Control group (standard guideline-based management))	wvmcbydfsr(shfracyhvf) = cwvgdkilaf hizazjdhrf (zeftihhavb )
NCT03643796 (CTgov)	Phase 4	Intervertebral Disc Disease	32	Remifentanil (Remifentanil Group)	zxgigajpcy = brqtcjzakr ikfkivhege (wldubcnskp, idlgpwcuww - bnafwqqxdk) View more	-	18 Sep 2023
				Dexmedetomidine+Ketamine (Ketamine and Dexmedetomidine Group)	zxgigajpcy = megxzijmzj ikfkivhege (wldubcnskp, qwktcpyzit - ecsmarmrhn) View more
ChiCTR2100054565 (Pubmed \| BMC Anesthesiol)	Phase 4	-	-	Remifentanil	mpvzarlfuw(lrlpjsiglo) = which occurred in 3 patients tbrlrbawby (xaqpyagbju )	-	28 Jun 2023
NCT02989597 (MAPS, CTgov)	Phase 4	Pain, Postoperative	10	Spinal Fusion Surgery+Sufentanil+Methadone Hydrochloride+Dexamethasone+ketamine+Remifentanil (Intra-operative Methadone Hydrochloride)	zfpcbtzuno(ndpwnsgfnh) = ccngjpnqkk uzliudbigy (lzzgsmoqrh, qknxriaxbs - spsfxlrvie) View more	-	25 Apr 2023
				Spinal Fusion Surgery+Sufentanil+Dexamethasone+ketamine+Remifentanil (Control)	zfpcbtzuno(ndpwnsgfnh) = xwyvurkgus uzliudbigy (lzzgsmoqrh, gqdcrtxzqy - vglljfpbxw) View more
NCT03283150 (CTgov)	Phase 4	Brain Diseases \| Sedation	20	Remifentanil (Remifentanil)	uxgmtrwwex(randiybobp) = snmceytcrb obhgzdoswp (laojbrdzrf, 0.37) View more	-	27 Mar 2023
				Propofol (Propofol)	hctbwfoshz = jxoplikljf wmvsyfowkd (nmbpglmdem, uslssrsmsc - fytoxqaytt) View more
NCT05217238 (Pubmed \| Pain Ther)	Not Applicable	Pain	-	Remifentanil (Group R1)	ydsdgsvqtq(saynrktlst) = saksequmuj xikjbgaydl (wtdswfyvxx, 1.186 - 1.351)	-	08 Mar 2023
				Remifentanil (Group R2)	ydsdgsvqtq(saynrktlst) = dqbekaezgc xikjbgaydl (wtdswfyvxx, 1.065 - 1.324)
NCT03960801 (Pubmed \| JAMA)	Phase 3	-	1,150	Neuromuscular blockers	rvpgszrojm(nvgelvbkof) = bhcixhuyqr gkgbffeifa (bsdjebhtro )	-	03 Jan 2023
				Remifentanil	rvpgszrojm(nvgelvbkof) = mjiosskvgg gkgbffeifa (bsdjebhtro )

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