Labetalol Infusion and Dexmedetomidine Infusion in Hypotensive Anesthesia

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.

Study Overview

• Status: Recruiting
• Conditions: Hypotensive Anesthesia; Ear, Nose and Throat Procedure
• Intervention / Treatment: Drug: Hypotensive anesthesia in ear, nose and throat surgeries using labetalol and dexmedetomidine infusions

Detailed Description

Hypotensive anaesthesia is the deliberate lowering of a patient's blood pressure during surgery. It is necessary during ear, nose and throat surgery for drying surgical field, ease in operation procedure and shortening of the duration of surgery. Labetalol is a unique parenteral anti-hypertensive drug that has selective α1 and non- selective β adrenergic antagonist effects. In humans, the β to α blocking potency ratio is 7: 1 for IV labetalol. Dexmedetomidine is highly selective alpha2 adrenergic agonist having several beneficial actions during the perioperative period. Activation of alpha2 adrenergic receptors in the brain and spinal cord inhibits neuronal firing causing hypotension and bradycardia. This study was designed to compare between the role of Labetalol infusion versus Dexmedetomidine infusion in hypotensive anesthesia in Ear, Nose and Throat surgeries.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Nourhan Osama, Master degree; Phone Number: 002 01064764758; Email: NourhanosamaMohamed@med.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 11517
    • Recruiting
    • Ain Shams University
    • Contact: Nourhan Osama, Master degree

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• American Society of Anesthesiologists I, II (ASA I, II) patients who were candidate for Ear, Nose and Throat surgeries.
• Age: between 20 and 50 years

Exclusion Criteria:

• Patients with uncontrolled hypertension, variable degrees of heart block, congestive cardiac failure, coagulopathy, cerebral insufficiency, hepatic or renal abnormality
• Patients on beta blocker or clonidine
• Pregnant or lactating females
• Patients who were allergic to any of the anesthetic or hypotensive drugs used in the study
• Patient refusal to be included in the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patients undergoing ear, nose and throat surgeries who will receive dexmedetomidine infusion; Dexmedetomidine group: the patients will receive deliberate hypotensive anesthesia with dexmedetomidine infusion (precedex ® 200 μg/2 ml; Hospira, Inc., Rocky Mount, USA) via syringe pump by adding 200 mcg (2ml) of dexmedetomidine to 48 ml of normal saline (final concentration of 4 mcg/ml) The patients will receive a loading dose of 1mcg/kg intravenously followed by an infusion of 0.7 mcg/kg/hour as maintenance dose.	Drug: Hypotensive anesthesia in ear, nose and throat surgeries using labetalol and dexmedetomidine infusions; The study compares the role of Labetalol infusion versus Dexmedetomidine infusion in hypotensive anesthesia in patients having ear, nose and throat surgeries
Active Comparator: Patients undergoing ear, nose and throat surgeries who will receive Labetalol infusion; Labetalol groups: the patients will receive deliberate hypotensive anesthesia with labetalol infusion (Labipress 100mg/20ml; Al Debeiky pharma(DBK) pharmaceutical co., Cairo, Egypt) via syringe pump by adding 100 mg (20ml) of Labetalol to 30ml of normal saline (final concentration of 2 mg/ml) The patients will receive a loading dose of 0.4mg/kg intravenously followed by an infusion of 0.04mg/kg/hour as maintenance dose.	Drug: Hypotensive anesthesia in ear, nose and throat surgeries using labetalol and dexmedetomidine infusions; The study compares the role of Labetalol infusion versus Dexmedetomidine infusion in hypotensive anesthesia in patients having ear, nose and throat surgeries

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean arterial blood pressure changes before induction of anesthesia & every 15 min throughout deliberate hypotension	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Heart rate changes before induction of anesthesia and every 15 min	12 months
Surgical site oligaemia will be evaluated by the surgeons by rating the amount of bleeding according to Modena bleeding score that provides five different levels (from "Grade 1 - no bleeding" to "Grade 5")	12 months
Surgeon satisfaction At the end of the surgery will be evaluated by one surgeon and recorded according to a 5-point Likert scale (5: excellent, 4: Good, 3: Satisfactory, 2: Poor, 1: Very poor)	12 months
Total anesthetic consumption including both inhalational anesthetic consumption and narcotics consumption.	12 months

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 21, 2024
• First Submitted That Met QC Criteria: December 21, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 21, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Labetalol; Hypotensive anesthesia
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypotension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Hypnotics and Sedatives; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Adrenergic beta-Antagonists; Adrenergic Antagonists; Sympathomimetics; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Dexmedetomidine; Antihypertensive Agents; Labetalol
• Other Study ID Numbers: FMASU MD105/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No