Labetalol Infusion and Dexmedetomidine Infusion in Hypotensive Anesthesia

Phase 4RecruitingNCT06752863

Ain Shams University80 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Hypotensive Anesthesia Ear, Nose and Throat Procedure

Interventions

Hypotensive anesthesia in ear, nose and throat surgeries using labetalol and dexmedetomidine infusionsDRUG

The study compares the role of Labetalol infusion versus Dexmedetomidine infusion in hypotensive anesthesia in patients having ear, nose and throat surgeries

Eligibility

Sex: ALLMin age: 20 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Ain Shams university

Cairo, Cairo Governorate, Egypt

RECRUITING

Outcomes

Primary Outcomes

Mean arterial blood pressure changes before induction of anesthesia & every 15 min throughout deliberate hypotension

Time frame: 12 months

Secondary Outcomes

Heart rate changes before induction of anesthesia and every 15 min

Time frame: 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")

Time frame: 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)

Time frame: 12 months

Total anesthetic consumption including both inhalational anesthetic consumption and narcotics consumption.

Time frame: 12 months

Central Contacts

Nourhan Osama, Master degree

CONTACT

002 01064764758 NourhanosamaMohamed@med.asu.edu.eg

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.