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

NCT06677970 / Not yet recruitingPhase 3IIT

Outcome in Patients Treated With Endovascular Thrombectomy - optIMAL Blood Pressure Control 2 (OPTIMAL-BP 2)

Though intravenous thrombolysis has been shown to improve symptoms in acute ischemic stroke patients, the recanalization rate remains low (22.6%) and only around 30% of patients benefit from the treatment. Recently, endovascular thrombectomy using stent retrievers or catheters has proven to be more effective, with a success rate of nearly 80%. However, only 50% of patients experience clinical improvement, highlighting the need for new treatment strategies to enhance outcomes. Current guidelines recommend maintaining systolic blood pressure (BP) below 180 mmHg after thrombectomy, but there is a lack of evidence regarding optimal blood pressure management post-reperfusion.
Four randomized clinical trials, including the OPTIMAL-BP trial, have examined blood pressure control following thrombectomy. Meta-analyses showed that intensive BP lowering did not reduce symptomatic hemorrhage and was associated with worse functional outcomes at 3 months. Specifically, lowering BP too aggressively after successful reperfusion could worsen outcomes by reducing perfusion to the ischemic penumbra. Therefore, this study will investigate whether a more targeted blood pressure elevation strategy could improve patient prognosis compared to standard BP control in those with post-thrombectomy systolic BP below 140 mmHg.
This is a prospective, randomized, open-label trial with blinded endpoint assessment (PROBE) design, aimed at comparing intensive and standard BP control strategies in acute ischemic stroke patients. Participants will be randomized 1:1 into either an intensive BP control group (targeting a 20% systolic BP increase, capped at 180 mmHg) or a standard BP control group (systolic BP below 180 mmHg).

Start Date01 Dec 2024

Sponsor / Collaborator

Yonsei University

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

100 Clinical Results associated with Labetalol Hydrochloride

100 Translational Medicine associated with Labetalol Hydrochloride

100 Patents (Medical) associated with Labetalol Hydrochloride

2,332

Literatures (Medical) associated with Labetalol Hydrochloride

01 Dec 2024·Pregnancy Hypertension-An International Journal of Womens Cardiovascular Health

Optimal treatment for women with acute hypertension in pregnancy; a randomized trial comparing intravenous labetalol versus nicardipine

Article

Author: de Groot, Christianne J M ; Bij de Weg, Jeske M ; bij de Weg, Jeske M. ; de Groot, Christianne J.M. ; Ganzevoort, Wessel ; de Boer, Marjon A. ; Willem Mol, Ben ; Hermes, Wietske ; de Boer, Marjon A ; van Bel, Frank ; Gravesteijn, Benjamin Y ; Gravesteijn, Benjamin Y.

OBJECTIVES:

Blood pressure control in severe hypertension of pregnancy is crucial for mother and neonate. In absence of evidence, guidelines recommend either intravenous labetalol or nicardipine. We compared the effectiveness and safety of these two drugs in women with severe hypertension in pregnancy.

STUDY DESIGN:

We performed an open label randomized controlled trial. Women with a singleton pregnancy complicated by severe hypertension (systolic ≥ 160 mmHg and/or diastolic ≥ 110 mmHg) requiring intravenous antihypertensive treatment were randomized to intravenous labetalol or intravenous nicardipine. The primary outcome was a composite adverse neonatal outcome defined as severe Respiratory Distress Syndrome (RDS), Broncho Pulmonary Dysplasia (BPD), Intraventricular Hemorrhage (IVH) IIB or worse, Necrotizing Enterocolitis (NEC), or perinatal death defined as fetal death or neonatal death before discharge from the neonatal intensive care unit (NICU). Based on a power analysis, we estimated that 472 women (236 per group) needed to be included to detect a difference of 15% in the primary outcome with 90% power. The study was halted prematurely at 30 inclusions because of slow recruitment and trial fatigue.

RESULTS:

Between August 2018 and April 2022, we randomized 30 women of which 16 were allocated to intravenous nicardipine and 14 to intravenous labetalol. The composite adverse neonatal outcome was not significantly different between the two groups (25 % versus 43 % OR 0.28 (95 % CI 0.05-1.43), p = 0.12)). Respiratory distress syndrome occurred more often in the labetalol group than in the nicardipine group (42.9 % versus 12.5 %). Neonatal hypoglycemia occurred more often in the nicardipine group than in the labetalol group (31 % versus 7 %). Time until blood pressure control was faster in women treated with nicardipine than in women treated with labetalol (45 (15-150 min vs. 120 (60-127,5) min).

CONCLUSION:

In our prematurely halted small RCT, we were unable to provide evidence for the optimal choice of treatment for severe hypertension to improve neonatal outcome and/or to obtain faster blood pressure control. Differences in Respiratory distress syndrome and neonatal hypoglycemia between the groups might be the result of coincidental finding due to the small groups included in the study. A larger randomized trial would be needed to determine the safest and most efficacious (intravenous) therapy for severe hypertension in pregnancy. This study emphasizes the challenges of conducting a RCT for the optimal treatment for these women.

01 Dec 2024·European Journal of Obstetrics & Gynecology and Reproductive Biology

Comparative efficacy and safety between intravenous labetalol and intravenous hydralazine for hypertensive disorders in pregnancy: A systematic review and meta-analysis of 19 randomized controlled trials

Review

Author: Kojima, Giovana Schlichta Adriano ; Faria, Hilária Saugo ; de Azevedo, Benjamim Barbosa ; da Silva Júnior, Arlindo Bispo ; Bendaham, Lucas Cael Azevedo Ramos ; Simoni, Gabriel Henrique ; de Macedo Lins, Cynthia Dantas ; Ribeiro, Bianca Leal ; de Abreu, Victoria Städler ; de Araújo Melo, Keliany Carla Duarte ; Soares, Victor Gonçalves ; Gonçalves, Ocílio Ribeiro ; de Araújo Melo, Keliany C. Duarte

INTRODUCTION:

Hypertensive disorders during pregnancy elevate the likelihood of unfavorable outcomes for both mother and fetus. In cases of acute hypertension, several pharmacological interventions are available to lower blood pressure, such as hydralazine, a direct arteriolar vasodilator, and labetalol, a combined alpha and beta-blocker.

OBJECTIVES:

This systematic review and meta-analysis of randomized controlled trials (RCTs) aims to compare the efficacy and safety of intravenous labetalol and intravenous hydralazine for acute hypertensive disorders during pregnancy.

METHODS:

We systematically searched PubMed, Embase and Cochrane for studies comparing labetalol versus hydralazine in pregnant patients. The primary outcomes were median arterial blood pressure (MABP), diastolic blood pressure (DBP) and systolic blood pressure (SBP). We performed statistical analyses using R 4.1.1. Heterogeneity was examined with the Cochran Q test and I² statistics. Risk ratios (RR) and mean differences (MD) with 95% confidence intervals (CI), were computed with a random-effects model.

RESULTS:

Nineteen RCTs were included in this meta-analysis, comprising 2,261 patients. Among them, 1,131 (50 %) received treatment with labetalol. There was no statistically significant difference between groups in terms of SBP (MD -1.74; 95 % CI -6.72 to 3.23; p = 0.49; I² = 93 %), MABP (MD -0.72; 95 % CI -2.34 to 0.90; p = 0.39; I² = 0 %), DBP (MD 0.25; 95 % CI -4.72 to 5.21; p = 0.92; I² = 96 %), tachycardia (RR 0.42; 95 % CI 0.15 to 1.18; p = 0.099; I² = 41 %), and placenta abruption (RR 0.42; 95 % CI 0.15 to 1.16; p = 0.093; I² = 0 %). However, labetalol significantly reduced maternal hypotension (RR 0.26; 95 % CI 0.21 to 0.33; p < 0.001; I² = 41 %) compared with hydralazine.

CONCLUSION:

This systematic review and meta-analysis of RCTs found that labetalol and hydralazine were efficient for hypertension disorders in pregnancy. However, labetalol reduced the incidence of maternal hypotension.

01 Dec 2024·European journal of obstetrics & gynecology and reproductive biology: X

A rapid diagnostic technique based on metabolomics to differentiate between preeclampsia (PE) and chronic kidney disease (CKD) using maternal urine

Article

Author: Zhuang, Xu ; Lv, Xin ; Gao, Boyan ; Hou, Jingli

Similar clinical manifestations between preeclampsia and chronic kidney diseases can lead to potential misdiagnosis. Therefore, it is crucial to investigate effective diagnostic approaches that can reduce misdiagnosis and ensure the well-being of pregnant women. In this study, urine samples collected from 44 individuals with preeclampsia, 37 individuals with chronic kidney disease, and 37 healthy pregnant women were analyzed using metabolomic and proteomic strategies to distinguish between these two diseases. A total of 15 small molecules were tentatively identified as biomarkers to differentiate these two diseases, including potential internally exposed drugs and their metabolites like labetalol and SN-38, metabolites of exogenous substances like 3-phenylpropyl glucosinolate, and endogenous substances related to metabolism such as isoglobotriaose and chitobiose. Metabolic differences between preeclampsia from healthy pregnant women, as well as the differences between chronic kidney disease and healthy pregnant women were also investigated. Major mechanistic pathways were investigated based on the combination of metabolomic and proteomic, amino acid metabolisms and folate metabolism play key roles in distinguishing preeclampsia and chronic kidney disease. Two patients who were initially diagnosed with chronic kidney disease were found to have a closer association with preeclampsia following metabolomic analysis. Subsequent clinical symptoms and manifestations further supported the diagnosis of preeclampsia, and one of patient's pregnancy was ultimately terminated due to severe preeclampsia. Results of this study contribute to a better understanding of the pathogenesis and clinical diagnosis of preeclampsia, offering insights that could potentially improve future diagnostic and management approaches.

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	US	Schering Corp.	01 Aug 1984
Hypertension	US	Alvogen, Inc.	01 Aug 1984
Essential Hypertension	JP	Sandoz AG	07 Oct 1982

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


DOPPS (ISN WCN2024)	Not Applicable	Maintenance	-	Metoprolol	tjorbndkdw(eorikymgtz): P-Value = 0.83	Positive	01 Apr 2024
				Atenolol
NCT04343235 (CTgov)	Phase 4	Hypertension, Pregnancy-Induced	13	labetalol+Furosemide (Labetalol + Furosemide)	mmbqkpqkqg(epcgjhefrf) = obfhkmzdeu tlsmtmnxzl (uvdefqrjgy, cqivxscqsp - klanfrtydd) View more	-	23 Oct 2023
				labetalol (Labetalol Only)	mmbqkpqkqg(epcgjhefrf) = myhvonsepp tlsmtmnxzl (uvdefqrjgy, kirujwgeam - ztvocquurn) View more
NCT04116112 (BEST-II, CTgov)	Phase 2	Thrombosis \| Stroke	120	Labetalol+Nicardipine+Hydralazine (Higher Systolic Blood Pressure (SBP) Target)	zlhldvmwia(uakxxxbwcn) = awphpyuqfz gbrjkjfubr (kgkqjbwviy, pkswmpiwjc - hckbbowscm) View more	-	12 Oct 2023
				Labetalol+Nicardipine+Hydralazine (Lower SBP (<160 mmHg) Target)	zlhldvmwia(uakxxxbwcn) = howvmlkxvh gbrjkjfubr (kgkqjbwviy, bmvrclqyyn - vxtbhxxwxn) View more
NCT04539379 (ZU-IRB#: 6353-23-3-2020, Pubmed \| J Clin Monit Comput)	Not Applicable	Pre-Eclampsia	-	Magnesium sulfate	ddredidgof(sxxxmyhmjn) = gfftqlmmqg cpisvsztmy (baayrybkfd )	Positive	01 Aug 2023
				Labetalol	ddredidgof(sxxxmyhmjn) = uoftosacjn cpisvsztmy (baayrybkfd )
NCT03506724 (CTgov)	Phase 4	Pre-Eclampsia	109	Labetalol (Intravenous Labetalol)	xyhjbujvql(jndlzogdix) = suvuxriykg kfwewvftll (xakpprnftf, byxjtlgzpp - kzzjdkoiwg) View more	-	24 May 2021
				Nifedipine (Oral Nifedipine)	xyhjbujvql(jndlzogdix) = iieubxaxfo kfwewvftll (xakpprnftf, ugrfdcpboz - kdzxmcqdol) View more
ASN2020	Not Applicable	-	-	Highly dialyzable BB (HDBB)	ccevttnlhk(hrbuxgjdax): RR = 1.03 (95% CI, 0.88 - 1.22) View more	Negative	19 Oct 2020
				Poorly dialyzable BB (PDBB)
ISN WCN2020	Not Applicable	First line \| Add-on	56	IV Labetalol	ezfqdzvlhw(ucyawggjbh) = yujisijqmx meenqgapbu (qchqlqbevk ) View more	Positive	01 Mar 2020
				IV Nitroprusside/Nitroglycerine	ezfqdzvlhw(ucyawggjbh) = bkqtygbnvm meenqgapbu (qchqlqbevk ) View more
NCT01114971 (CTgov)	Phase 4	Pain, Postoperative	75	Esmolol+Labetalol (Fentanyl)	zjhuzcusoo(pjslkxfnkd) = ogwxhnimxg fduqqoehug (qmjnjzrzvn, gtqkzdbwpc - acplszrjfa) View more	-	20 Feb 2020
				Esmolol+Fentanyl (Labetalol)	zjhuzcusoo(pjslkxfnkd) = nvzwesmrap fduqqoehug (qmjnjzrzvn, ytxdlpnpfi - ytneocudue) View more
NCT02168309 (CTgov)	Not Applicable	Hypertension	50	Labetalol (Labetalol)	ipfwwxrese(mojqusrdox) = fmmqnbwlye nqdvfwvdan (mjvqnbihbn, npivqactvp - behpbxnmhp) View more	-	13 Dec 2017
				Nifedipine (Nifedipine)	ipfwwxrese(mojqusrdox) = ngbroraeed nqdvfwvdan (mjvqnbihbn, murgmsfrwq - gtxtbflxpq) View more
ISRCTN40973936 (Pubmed \| Hypertension)	Not Applicable	Hypertension, Pregnancy-Induced First line	112	Labetalol	bbneaqafls(sitzvdqapg) = 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 rvnyurogxw (reimhdmhfy )	-	01 Nov 2017
				Nifedipine-modified release

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