A Comparison of Dexmedetomidine, Nicardipine, and Labetalol to Induce Hypotensive Anesthesia and Their Effects on Surgeon Visibility, Blood Loss, Hemodynamic Parameters, Operation Time, and Adverse Events During Orthognathic Surgery

The overall objective of this double blinded, randomized controlled trial (RCT) is to compare specific outcomes of three medications (Dexmedetomidine, Nicardipine, and Labetalol) which are routinely used to lower blood pressure used during general anesthesia for orthognathic (jaw) surgery. The outcome measures for the study will be surgical field visibility, estimated blood loss, hemodynamic parameters, operation time, and adverse events.
The specific objectives of this study are to compare:
1. Dexmedetomidine, Nicardipine, and Labetalol's effect on the quality of the surgical field. (Primary Outcome)
2. Dexmedetomidine, Nicardipine, and Labetalol's effect on estimated blood loss.
3. Dexmedetomidine, Nicardipine, and Labetalol's effect on hemodynamic parameters including systolic blood pressure, mean arterial pressure, and heart rate.
4. Dexmedetomidine, Nicardipine, and Labetalol's effect on operation time.
5. Dexmedetomidine, Nicardipine, and Labetalol's effect on adverse events.
The investigators will evaluate healthy adult male and female patients who require jaw surgery at Boston Medical Center. The anticipated 90 participants will be randomized into three groups: ) A Labetalol group in which the patients receive hypotensive anesthesia with the aid of labetalol, 2) A Nicardipine group in which the patients receive hypotensive anesthesia with the aid of nicardipine, and 3) A Dexmedetomidine group in which the patients receive hypotensive anesthesia with the aid of dexmedetomidine.
The time it will take for each individual participant ranges from 1-3 months. This time includes the pre-operative visit, the surgical procedure, a 1-week post-operation visit, and then followed for 30 days post-operatively after which the patient's participation in the study will conclude.

Start Date01 Jan 2025

Sponsor / Collaborator

Boston Medical Center

NCT05551104

/ RecruitingPhase 3IIT

Safest Choice of Antihypertensive Regimen for Postpartum Hypertension: A Randomized Control Trial (SCARPH)

The purpose of this investigator-initiated randomized control trial is to determine whether oral Nifedipine versus oral Labetalol is superior in controlling high blood pressures in the postpartum period.

Start Date01 Dec 2024

Sponsor / Collaborator

Loma Linda University

NCT06752863

/ RecruitingPhase 4IIT

Comparative Study of Labetalol Infusion Versus Dexmedetomidine Infusion in Hypotensive Anesthesia in Ear, Nose and Throat Surgeries

this study aims to compare between the role of Labetalol infusion versus Dexmedetomidine infusion in hypotensive anesthesia in Ear, Nose and Throat surgeries.

Start Date27 Nov 2024

Sponsor / Collaborator

Ain Shams University

100 Clinical Results associated with Labetalol Hydrochloride

100 Translational Medicine associated with Labetalol Hydrochloride

100 Patents (Medical) associated with Labetalol Hydrochloride

2,374

Literatures (Medical) associated with Labetalol Hydrochloride

15 Jan 2025·The Journal of Maternal-Fetal & Neonatal Medicine

Race/ethnicity differences in response to acute antihypertensive treatment of peripartum severe hypertension

Article

Author: Kilpatrick, Sarah J. ; Pon, Fay F. ; Greene, Naomi H.

BACKGROUNDHypertensive disorders of pregnancy increase maternal morbidity, mortality, and long-term risk for cardiovascular disease. The rising incidence of chronic hypertension and preeclampsia disproportionately affects people of color. There is a paucity of published data examining differences in the effectiveness of acute antihypertensive agents between pregnant patients of different races/ethnicities. We aimed to determine if the effectiveness of acute antihypertensive agents for peripartum severe hypertension differs by race/ethnicity.METHODSA retrospective cohort study of patients with severe peripartum hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 110 mm Hg confirmed within 15 min) to determine whether the effectiveness of blood pressure control using nationally recommended medications (hydralazine, labetalol, nifedipine) differed by race/ethnicity. The primary outcome was reduction and maintenance of blood pressure to target ranges (140-150/90-100 mm Hg or below) for ≥4 h in each race/ethnicity group. Statistical tests included χ², Fisher's exact, analysis of variance, and multivariable logistic regression.RESULTSOf 729 patients receiving treatment for severe peripartum hypertension, all medications were effective (overall 86.4% efficacy) at controlling blood pressure. Labetalol was the most effective medication in White patients (93.0 vs. 74.7% for nifedipine and 86.5% for hydralazine, p < .001). No overall differences in medication effectiveness were found in Black, Asian, or LatinX patients. Black and Asian patients were more likely to experience >1 hypertensive episode [51.0 and 49.0%, respectively vs. 35.4% (White) and 40.0% (LatinX), p = .008].CONCLUSIONCurrently recommended therapies for severe peripartum hypertension are effective in controlling blood pressure for ≥4 h in patients of all race/ethnic groups. Labetalol was the most effective medication in White patients with no overall differences in medication effectiveness in Black, Asian, or LatinX patients.

01 Jan 2025·International Journal of Pharmaceutics

Hydrogel-forming microarray patches combined with powder-based reservoir for labetalol hydrochloride transdermal delivery

Article

Author: Detamornrat, Usanee ; Donnelly, Ryan F ; Larrañeta, Eneko ; Anjani, Qonita Kurnia

Hypertension is the most common pregnancy disorder and can lead to life-threatening conditions for both mother and fetus. However, managing this condition with oral and intravenous labetalol can be challenging, highlighting the need for alternative delivery methods. This study presents, for the first time, the development of novel powder-based reservoirs incorporated with hydrogel-forming microarray patches (MAPs) to facilitate the transdermal delivery of labetalol hydrochloride (HCl). A holder, created from poly(propylene) using a 3D printer, was designed to house labetalol HCl powder, which was then combined with hydrogel-forming MAPs. This novel system improved the insertion profile of MAPs into Parafilm® layers and excised full-thickness neonatal porcine skin, achieving up to 85 % of needle height penetration without compromising needle integrity (only 8 % height reduction after applying 32 N of force). The current holder design was able to load 50 mg of labetalol HCl and allowed for single or multiple injections of deionised water to dissolve the powder and facilitate permeation through dermatomed neonatal porcine skin in in vitro studies using a Franz cell setup. The results showed that this powder-based reservoir design delivered labetalol HCl more effectively over 24 h compared to directly compressed tablets. Additionally, poly(vinyl alcohol)/poly(vinyl pyrrolidone)/citric acid-based hydrogel-forming MAPs delivered more labetalol HCl than Gantrez® S-97/poly(ethylene glycol)-based MAPs (9 mg vs. 5 mg) in 24 h. This novel system holds promise for improving the delivery of compounds in a simple manner, though further design modifications for one-step application are needed.

01 Jan 2025·American Journal of Obstetrics & Gynecology MFM

Amlodipine versus nifedipine ER for the management of postpartum hypertension: a noninferiority randomized controlled trial

Article

Author: Lordo, Ross ; Pratt, Katelyn ; Carlson, Laura ; Self, Stella

BACKGROUNDPostpartum hypertension is an increasingly prevalent problem and optimizing its treatment is imperative in reducing maternal morbidity and improving long-term health outcomes. Despite this, data on treatment of postpartum hypertension is limited. While most available studies focus on labetalol and nifedipine ER, these medications are not frequently used for hypertension treatment in the non-obstetric setting. As we aim to establish best practices for managing postpartum hypertension, use of more commonly encountered antihypertensives should be evaluated.OBJECTIVETo evaluate the use of amlodipine for the treatment of postpartum hypertension, as assessed by postpartum length of stay.STUDY DESIGNIn a pragmatic, randomized controlled noninferiority trial, patients were assigned to amlodipine or nifedipine ER for treatment of postpartum hypertension. The primary outcome was time from delivery until discharge with a noninferiority limit of 24 hours. A sample size of 132 was needed to achieve 80% power with a 2-tailed alpha of 0.05. Intent-to-Treat and Per Protocol analyses were performed. Prespecified secondary outcomes included the need for additional antihypertensives, side effects, medication discontinuation, breastfeeding satisfaction, and readmission rate. A post-hoc analysis of time from medication initiation until hospital discharge was also performed.RESULTSFrom April 2021 to December 2022, 7618 patients were screened and 175 patients were randomized, with 132 meeting criteria for antihypertensive initiation. Baseline demographics were similar between groups. Amlodipine had a non-inferior length of stay compared to nifedipine ER (Intent-to-Treat Wilcoxon pseudo-median amlodipine=73.5 hours, nifedipine ER=72.0 hours, 95% CI -8.00 to 6.00). The remainder of analyses were performed only on the Per Protocol cohort. Time from medication initiation until hospital discharge was similar between groups (amlodipine=45.0 hours, nifedipine ER=45.5 hours, 95% CI -8.00 to 13.00). There were no differences in use of additional antihypertensives or patient-reported side effects or breastfeeding outcomes, but hypotension and tachycardia were less common with amlodipine use. Amlodipine was significantly less likely to be discontinued due to side effects (amlodipine n=0, nifedipine ER n=7 (10.1%), p=.02). Readmission rates were similar between groups.CONCLUSIONAmlodipine is noninferior to nifedipine ER for postpartum hypertension treatment, as defined by median length of postpartum stay. Rates of side effects were similar between groups, but there was a statistically significant difference in medication discontinuation rates.CLINICAL TRIAL REGISTRATIONClinicaltrials.gov, www.CLINICALTRIALSgov, NCT04790279.

News (Medical) associated with Labetalol Hydrochloride

03 Sep 2024

·www.pharmaceutical-technology.com

ESC 2024: Beta blocker treatment paradigm shifts for myocardial infarction

At the ESC Congress, Dr. Milton Packer highlighted recent research into beta blocker treatment for myocardial infarction. Credit: luchschenF via Shutterstock. A shift in the beta-blocker treatment paradigm has arrived with the changing myocardial infarction treatment landscape, said a researcher at the European Society of Cardiology (ESC) Congress, held from 31 August to 2 September. Over the past 40 years, the research space has operated on an understanding that immediate inhibition by beta-blockers reduces left ventricular rupture, and further myocardial infarction , said Dr. Milton Packer, distinguished scholar in cardiovascular science at Baylor University Medical Center, Dallas. Additionally, the belief was that delayed long-term blockade can lead to left ventricular dysfunction, he said. Beta-blockers are a class of drugs that act by inhibiting the actions of hormones such as adrenaline to slow down the heart. Commonly used beta blockers include Abbott ’s Tenormin (atenolol), MSD’s Cardicor (bisoprolol), and GSK ’s Trandate (labetalol). However, Packer explained that the beta blocker response has changed as percutaneous interventions, reperfusion therapies, antiplatelet drugs and more have entered the treatment landscape for myocardial infarction. At the ongoing ESC Congress talk titled “Should we give beta blockers post-myocardial infarction?” Packer said that questions have been raised surrounding the use of the drugs in patients with myocardial infarction and preserved ejection fraction, referencing the Phase IIII REDUCE-AMI study (NCT03278509). See Also: Novavax wins FDA emergency approval for updated Covid-19 vaccine Combating Pharmaceutical Crime with On-Dose Authentication REDUCE-AMI, which was funded by the Swedish Research Council, tested the use of beta-blockers after myocardial infarction and preserved ejection fraction. The study found that for patients with acute myocardial infarction who underwent early coronary angiography and had preserved left ventricular ejection fraction, long-term beta-blocker treatment did not lower the risk of death from any cause or new myocardial infarctions compared to no beta-blocker use. Despite the conclusion of the REDUCE-AMI study, Packer highlighted the fact that researchers have only investigated and proven the effectiveness of non-selective beta blockers in post-myocardial infarction trials, so further research is required. He added that physicians will have to take into account the degree of beta-blockade in future treatment regimens.

VaccinePhase 3Drug ApprovalClinical Result

17 Jun 2024

·www.drugs.com

2008 to 2021 Saw Increase in Prevalence of Chronic HTN in Pregnancy

MONDAY, June 17, 2024 -- For pregnant individuals, the prevalence of chronic hypertension more than doubled between 2008 and 2021, according to a study published online June 17 in Hypertension . Stephanie A. Leonard, Ph.D., from the Stanford University School of Medicine in California, and colleagues analyzed commercial insurance claims from 2007 to 2021 and assessed the prevalence of chronic hypertension during pregnancy and trends in oral antihypertensive medication use. The researchers found that between 2008 and 2021, the prevalence of chronic hypertension increased steadily from 1.8 to 3.7 percent among 1,900,196 pregnancies. During the study period, antihypertensive medication use among those with chronic hypertension was relatively stable (57 to 60 percent). There was a decrease seen in the proportion of pregnant individuals with chronic hypertension treated with methyldopa or hydrochlorothiazide (from 29 to 2 percent and from 11 to 5 percent, respectively), and there was an increase seen in the proportion treated with labetalol or nifedipine (from 19 to 42 percent and from 9 to 17 percent, respectively). Following the 2017 American College of Cardiology and American Heart Association hypertension guidelines, there was no change observed in the prevalence or treatment of chronic hypertension during pregnancy. "There were large shifts in the medications used to treat chronic hypertension in pregnancy, with labetalol supplanting methyldopa as the most commonly used antihypertensive medication," the authors write. One author disclosed ties to the pharmaceutical industry.

AHAClinical Study

23 May 2024

·www.fiercepharma.com

Pfizer's Hospira recalls 5 injectable drug lots due to report of leak, potential seal issues

Recalled batches of Hospira's buprenorphine hydrochloride (HCI) injection and its labetalol hydrocholoride injection were distributed to hospitals and wholesalers nationwide between September 2023 and April 2024, according to a notice posted on the FDA website. After a report of leaking product, Pfizer’s Hospira unit is pulling five lots of sterile injectable medicines from distribution. The recall affects certain batches of the company’s buprenorphine hydrochloride (HCI) injection and its labetalol hydrocholoride injection, both of which come in Pfizer’s Carpuject syringe device. While the company has not yet received reports of “any relevant” adverse events tied to the recalled batches, it opted to pull the meds due to the potential for incomplete crimp seals. The concern followed one custumer complaint about a leaking product, Pfizer said in a notice posted by the FDA. Hospira’s buprenorphine product is indicated for intravenous or intramuscular administration to treat pain management that requires an opioid analgesic, while the labetalol HCI product controls blood pressure during severe hypertension. The recalled batches were distributed to wholesalers and hospitals across the U.S. between September 2023 and April of this year. The buprenorphine HCI lots expire in September and October of this year, while the three lots of labetalol injections carry expiration dates in 2025. Pfizer is arranging for the return of the affected products and instructed those with remaining inventory to discontinue use, stop distribution and quarantine the injections immediately. Late last year, contamination concerns led to mutiple recalls for the Pfizer subsidiary. First, the company yanked one lot of its injectable cancer med bleomycin after a customer flagged glass particulates in one vial. Then, two strengths of injectable sodium bicarbonate and one lot of atropine sulfate injection were pulled due to the “potential presence of glass particulate matter” spotted during routine product inspections. The spree continued with another market pull of one lot of vancomycin hydrochloride injection vials. That recall was attributed to a report of two visible glass particles in one vial.

Drug ApprovalClinical Result

100 Deals associated with Labetalol Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D00600	Labetalol Hydrochloride	C07AG01	DB00598

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Hypertension	CN	Jiangsu Desano Pharmaceutical Co. Ltd.	01 Jan 1985
Essential Hypertension	JP	Sandoz AG	07 Oct 1982

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


DOPPS (ISN WCN2024)	Not Applicable	Maintenance	-	Metoprolol	(sbkjunyweb): P-Value = 0.83	Positive	01 Apr 2024
				Atenolol
NCT04343235 (CTgov)	Phase 4	Hypertension, Pregnancy-Induced	13	labetalol+Furosemide (Labetalol + Furosemide)	uuqgerkuud(uiyffbtyqr) = jvehdrollg dlshvvpjtg (dsmsogpgtj, dmtzsvllxj - qpxulfgfdn) View more	-	23 Oct 2023
				labetalol (Labetalol Only)	uuqgerkuud(uiyffbtyqr) = elejnosftz dlshvvpjtg (dsmsogpgtj, bwrwafpejv - rqnxjvhcjv) View more
NCT04116112 (BEST-II, CTgov)	Phase 2	Thrombosis \| Stroke	120	Labetalol+Nicardipine+Hydralazine (Higher Systolic Blood Pressure (SBP) Target)	aosdjeldnw(ixxlcmrkyc) = zcbfbtaxwy adirmkwtfz (ofiigalwko, nosdopdmxo - gbuqmolojq) View more	-	12 Oct 2023
				Labetalol+Nicardipine+Hydralazine (Lower SBP (<160 mmHg) Target)	aosdjeldnw(ixxlcmrkyc) = qnforesrlc adirmkwtfz (ofiigalwko, nmalcytbsm - cnpqhcmici) View more
NCT04539379 (ZU-IRB#: 6353-23-3-2020, Pubmed \| J Clin Monit Comput)	Not Applicable	Pre-Eclampsia	-	Magnesium sulfate	npiydbevxb(cbbuvhojqo) = thkyiurkfb avbgcmhqaq (odwklpjbkh )	Positive	01 Aug 2023
				Labetalol	npiydbevxb(cbbuvhojqo) = jrbxhjawxb avbgcmhqaq (odwklpjbkh )
NCT04688203 (Pubmed \| Patient Saf Surg)	Phase 1/2	-	50	Magnesium sulfate	vxmiwdhpda(pepcqydbxv) = vewmagwnad rywidlpopi (jrloqvukho )	-	19 Aug 2022
				Labetalol	vxmiwdhpda(pepcqydbxv) = romtuqdgnw rywidlpopi (jrloqvukho )
NCT03809065 (Pubmed \| BMC Anesthesiol)	Phase 4	Hypotension	40	Nitroglycerin	bmkxpwkzys(vomtjttxdg) = foaqnzrwzn jhozacnsau (dehbkbzrfd )	-	17 Apr 2020
				Labetalol	bmkxpwkzys(vomtjttxdg) = iiyrdgedag jhozacnsau (dehbkbzrfd )
ISN WCN2020	Not Applicable	First line \| Add-on	56	IV Labetalol	iuffscqxtj(hjniyrimgj) = owyiuauviy pvttitqqxu (cdfwjpmrlq ) View more	Positive	01 Mar 2020
				IV Nitroprusside/Nitroglycerine	iuffscqxtj(hjniyrimgj) = kuzhbiffxe pvttitqqxu (cdfwjpmrlq ) View more
NCT01114971 (CTgov)	Phase 4	Pain, Postoperative	75	Esmolol+Labetalol (Fentanyl)	(ctktxyrjwr) = cmznrhsafe twhrljknbs (fsenkotlbt, ihhiwuxxjz - hrjxdixyjt) View more	-	20 Feb 2020
				Esmolol+Fentanyl (Labetalol)	(ctktxyrjwr) = fmhzrqhdiz twhrljknbs (fsenkotlbt, jjtnahoajh - mccdqfncpl) View more
ISRCTN40973936 (Pubmed \| Hypertension)	Not Applicable	Hypertension, Pregnancy-Induced First line	112	Labetalol	iibfukpshv(uoubtqhzip) = Nifedipine use was associated with a 7.4-mm Hg reduction (-14.4 to -0.4 mm Hg) in central aortic pressure, measured by pulse wave analysis itjlcowvza (llbzkullhj )	-	01 Nov 2017
				Nifedipine-modified release
NCT02168309 (Pubmed \| Hypertens Pregnancy)	Not Applicable	Hypertension	50	Oral labetalol	quxtkpbklm(pwpcjxtoog) = gzqjedpibc rmzbkbqeol (obdkuzcyef )	-	02 Jan 2017
				Oral extended release nifedipine	quxtkpbklm(pwpcjxtoog) = lzbjqlnxhx rmzbkbqeol (obdkuzcyef )

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