Labetalol Infusion and Dexmedetomidine Infusion in Hypotensive Anesthesia

NCT06752863 | Recruiting Phase 4 DMC

• 1 other identifier: FMASU MD105/2024
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypotensive Anesthesia; Ear, Nose and Throat Procedure

Keywords

Hypotensive anesthesia; Labetalol; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

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

  12 months

Secondary Outcomes (4)

• 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

Study Arms (2)

Patients undergoing ear, nose and throat surgeries who will receive dexmedetomidine infusion

ACTIVE COMPARATOR

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

Patients undergoing ear, nose and throat surgeries who will receive Labetalol infusion

ACTIVE COMPARATOR

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

Interventions

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

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

Patients undergoing ear, nose and throat surgeries who will receive Labetalol infusion; Patients undergoing ear, nose and throat surgeries who will receive dexmedetomidine infusion

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams university

Cairo, Cairo Governorate, 11517, Egypt

RECRUITING

Central Study Contacts

Nourhan Osama, Master degree

CONTACT

002 01064764758; NourhanosamaMohamed@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: data collector is also masked in the clinical trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2024
• First Posted: December 31, 2024
• Study Start: November 27, 2024
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 31, 2024

Record last verified: 2024-06

Locations

EG (1)