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 Mar 2025

Sponsor / Collaborator

Boston Medical Center

CTR20244831

/ Active, not recruitingNot Applicable

盐酸拉贝洛尔片在健康成年受试者中空腹状态及高脂餐后单次口服给药的随机、开放、四周期、两序列、重复交叉设计生物等效性试验方案

[Translation] A randomized, open-label, four-period, two-sequence, repeated crossover bioequivalence study of labetalol hydrochloride tablets in healthy adult subjects after single oral administration in the fasting state and after a high-fat meal

主要研究目的：研究重庆圣华曦药业股份有限公司生产的盐酸拉贝洛尔片（200mg）在中国健康受试者中空腹状态及高脂餐后以口服途径单次给药的药代动力学特征，并以Aspen Pharma Schweiz GmbH持有，Aspen Pharma Schweiz GmbH生产的盐酸拉贝洛尔片（商品名：Trandate®；规格：200mg）为参比制剂，进行生物等效性评价。次要研究目的：初步考察盐酸拉贝洛尔片受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetic characteristics of labetalol hydrochloride tablets (200 mg) produced by Chongqing Shenghuaxi Pharmaceutical Co., Ltd. in Chinese healthy subjects after a single oral administration in the fasting state and after a high-fat meal, and to evaluate the bioequivalence of labetalol hydrochloride tablets (trade name: Trandate®; specification: 200 mg) owned by Aspen Pharma Schweiz GmbH and produced by Aspen Pharma Schweiz GmbH as the reference preparation. The secondary purpose of the study is to preliminarily investigate the safety of the test preparation and reference preparation of labetalol hydrochloride tablets in healthy subjects.

Start Date04 Jan 2025

Sponsor / Collaborator

Chongqing Shenghuaxi Pharmaceutical Co. Ltd.

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

4,120

Literatures (Medical) associated with Labetalol Hydrochloride

01 Apr 2025·SEPARATION AND PURIFICATION TECHNOLOGY

Using artificial neural networks to elucidate retention interactions on stationary phases with amine moieties dedicated to supercritical fluid chromatography

Author: Plachka, Katerina ; Gazarkova, Tatana ; Pilarova, Veronika ; Plachká, Kateřina ; Nováková, Lucie ; Pilařová, Veronika ; Svec, Frantisek ; Švec, František ; Garrigues, Jean-Christophe ; Novakova, Lucie ; Gazárková, Taťána

The retention mechanisms of small mols. on a wide range of stationary phases using different mobile phase compositions are one of the most discussed topics in current state-of-the-art supercritical fluid chromatog. (SFC).Although various theories have been published on retention behavior, prediction, and stability over time, an in-depth insight into the mechanisms is still lacking.Our study focused on the description of the retention mechanisms on columns with amine moieties, i.e., 2-ethylpyridine, 2-picolylamine, 1-aminoanthracene, and diethylamine, dedicated to SFC, using three different compositions of organic modifier, i.e., methanol, methanol + 10 mmol/L NH₃, and methanol + 2% H₂O, in CO₂.An extensive set of analytes characterized by more than 200 mol. descriptors was used.The importance of the effect of each mol. descriptor on the retention behavior was determined by artificial neural networks.Thus, the descriptors increasing and/or decreasing retention on individual columns using different mobile phase compositions were defined.The data collected over one year of column use were statistically evaluated to describe the retention behavior of small mols. on the tested stationary phases using three organic modifiers and to describe the changes in retention behavior over time.As the development of the SFC method can be laborious and time-consuming, this publication offers a detailed description of the interactions taking place between the analyte and the SFC stationary phase.Understanding these fundamental processes will enable faster development of SFC methods using quality-by-design principles.

01 Mar 2025·Pregnancy Hypertension-An International Journal of Womens Cardiovascular Health

Is there a relationship between visit-to-visit blood pressure variability and adverse perinatal outcomes?

Article

Author: Renwick, Beth ; Myers, Jenny E ; Shawkat, Emma ; Ormesher, Laura ; Stewart, Jill

OBJECTIVE:

To explore the relationship between blood pressure (BP) variability and perinatal outcomes.

STUDY DESIGN:

This was a retrospective study of 996 pregnant women with hypertension/risk factors for hypertension in pregnancy. BP variability was calculated by visit-to-visit standard deviation (SD) and mean difference (MD). Logistic regression explored the relationship between BP variability and perinatal outcome, adjusting for confounders.

MAIN OUTCOME MEASURES:

Correlation between BP variability and i) fetal growth restriction (FGR) and ii) preterm birth (PTB).

RESULTS:

FGR and PTB complicated 128/996 (13 %) and 233/996 (23 %) pregnancies. At visit 1, 61 (6 %) women were taking labetalol, 125 (13 %) were taking calcium channel blockers and 780 (78 %) were not taking antihypertensives. Increased BP variability was associated with FGR and PTB. These relationships persisted after adjustment for number of antihypertensives, pre-pregnancy BP, BMI, ethnicity and previous FGR for systolic but not diastolic BP variability (adjusted OR for FGR: 1.16 [95 % C.I. 1.03-1.30]; PTB: 1.16 [1.05-1.29]). However, statistical significance was lost after adjustment for maximum BP. Nifedipine was associated with increased BP variability, compared with labetalol, despite adjustment for ethnicity and pre-existing hypertension (adjusted difference: 1.93 mmHg [0.13-3.73], p = 0.04).

CONCLUSIONS:

Increased visit-to-visit systolic but not diastolic BP variability is associated with adverse perinatal outcomes. Nevertheless, it is unclear whether BP lability directly influences perinatal outcome, or merely reflects peak BP. The difference in BP variability between antihypertensives may reflect varying effectiveness or factors influencing antihypertensive choice. Prospective research is needed to investigate any potential link between antihypertensive medications, BP variability and perinatal outcome.

01 Jan 2025·INTERNATIONAL JOURNAL OF PHARMACEUTICS

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

Article

Author: Larrañeta, Eneko ; Detamornrat, Usanee ; Donnelly, Ryan F ; 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.

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.

to view more data

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	ywmdjaocmh(svqbidjgzj): P-Value = 0.83	Positive	01 Apr 2024
				Atenolol
NCT04343235 (CTgov)	Phase 4	Hypertension, Pregnancy-Induced	13	labetalol+Furosemide (Labetalol + Furosemide)	xgklxiismp(olcillacwh) = ocmyvszoae uyylfnceie (kdmwleoofo, hmmtazwrdj - vqprrjqybi) View more	-	23 Oct 2023
				labetalol (Labetalol Only)	xgklxiismp(olcillacwh) = vqxbgouhkq uyylfnceie (kdmwleoofo, sdvtzppcmw - dvgelkbvwk) View more
NCT04116112 (BEST-II, CTgov)	Phase 2	Thrombosis \| Stroke	120	Labetalol+Nicardipine+Hydralazine (Higher Systolic Blood Pressure (SBP) Target)	gdmfhulvvs(kbyghotnlv) = zandskjtwo chodasouuv (orwzsicdkq, kjyozxiuil - rghotbqexh) View more	-	12 Oct 2023
				Labetalol+Nicardipine+Hydralazine (Lower SBP (<160 mmHg) Target)	gdmfhulvvs(kbyghotnlv) = lynejouljy chodasouuv (orwzsicdkq, ufthoaklpj - kviexggsno) View more
NCT04539379 (ZU-IRB#: 6353-23-3-2020, Pubmed \| J Clin Monit Comput)	Not Applicable	Pre-Eclampsia	-	Magnesium sulfate	lzbbzbibut(orhfpquxfk) = xwsyciwfig qmskrtxspo (cfzgvmkkds )	Positive	01 Aug 2023
				Labetalol	lzbbzbibut(orhfpquxfk) = dulmirzkva qmskrtxspo (cfzgvmkkds )
NCT03506724 (CTgov)	Phase 4	Pre-Eclampsia	109	Labetalol (Intravenous Labetalol)	rwflmjuglp(qyrtubruoi) = xlhkoczcdt jzeiowsejw (qomkkrtluz, fdclufjivh - efjjbrqsxs) View more	-	24 May 2021
				Nifedipine (Oral Nifedipine)	rwflmjuglp(qyrtubruoi) = nojuawsnjl jzeiowsejw (qomkkrtluz, skyzyagbly - saolfjqrqa) View more
ASN2020	Not Applicable	-	-	Highly dialyzable BB (HDBB)	alozjxcwru(wmqwoiaplf): 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	uhyrymqijk(mrbknfvard) = oxovxlrybs uclyannvdx (gwqlppbkhs ) View more	Positive	01 Mar 2020
				IV Nitroprusside/Nitroglycerine	uhyrymqijk(mrbknfvard) = msdddyypiy uclyannvdx (gwqlppbkhs ) View more
NCT01114971 (CTgov)	Phase 4	Pain, Postoperative	75	Esmolol+Labetalol (Fentanyl)	dtqngzdfeg(bnwbwgcmje) = kbvdiieivq zpchvayole (bghqfvvsag, qwtrfezdgb - ahrkkbznkj) View more	-	20 Feb 2020
				Esmolol+Fentanyl (Labetalol)	dtqngzdfeg(bnwbwgcmje) = yujjmmxutg zpchvayole (bghqfvvsag, iwalbasqgh - lwzxnpzjhx) View more
NCT02168309 (CTgov)	Not Applicable	Hypertension	50	Labetalol (Labetalol)	oynomzmpzi(kptduafnif) = zgqvmcqjtc qhcdrcivyy (aduvxacsgm, waqcfuwbps - gsfokyhqen) View more	-	13 Dec 2017
				Nifedipine (Nifedipine)	oynomzmpzi(kptduafnif) = syvkxmoicl qhcdrcivyy (aduvxacsgm, fmefnwfsty - usqjgvfcvc) View more
ISRCTN40973936 (Pubmed \| Hypertension)	Not Applicable	Hypertension, Pregnancy-Induced First line	112	Labetalol	haygetnojb(skydiqvngv) = 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 hnzwdztwhc (vjyhgeuzgp )	-	01 Nov 2017
				Nifedipine-modified release

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