Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
ID07192081

Comparative Efficacy of Intravenous Labetalol and Lignocaine in Mitigating Hemodynamic Responses to Laryngoscopy During Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Led by Dr. Waseem Ullah · Updated on 2025-09-25

116

Participants Needed

1

Research Sites

7 weeks

Total Duration

On this page

Sponsors

D

Dr. Waseem Ullah

Lead Sponsor

H

Hayatabad Medical Complex

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to compare the effects of two medications, intravenous labetalol and lignocaine, on heart rate and blood pressure changes during laryngoscopy and intubation in patients undergoing elective laparoscopic cholecystectomy. The study focuses on adults with good physical status (ASA Grade I and II) aged 18 to 60, investigating which drug better maintains cardiovascular stability during this procedure by limiting heart rate and mean arterial pressure changes to within ±20% of baseline values. Participants will be randomly assigned to receive either labetalol at a dose of 0.25 mg/kg or lignocaine at 1.5 mg/kg. Both drugs are administered intravenously over 60 seconds, three minutes before laryngoscopy and intubation. The study will track blood pressure and heart rate from five minutes before induction until ten minutes after intubation, recording any adverse events such as bradycardia, hypotension, or allergic reactions. During the study, researchers will monitor systolic and diastolic blood pressures, mean arterial pressure, and heart rate closely around the time of airway instrumentation. They will also observe the use of any rescue medications and note adverse events from induction through recovery, approximately one hour. The findings aim to guide anesthesiologists in selecting the safer and more effective medication to control hemodynamic responses during laparoscopic surgery.

CONDITIONS

Brief Title

Comparative Efficacy of Intravenous Labetalol and Lignocaine in Mitigating Hemodynamic Responses to Laryngoscopy During Laparoscopic Cholecystectomy

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • ASA Grade I and II
  • Age 18 to 60 years
  • Scheduled for elective laparoscopic cholecystectomy
  • All genders
  • Provided informed consent
Not Eligible

You will not qualify if you...

  • Allergy to labetalol or lignocaine
  • Currently on antihypertensive medications for high blood pressure
  • ASA Grade III or higher
  • Known cardiovascular, kidney, liver, or endocrine disorders
  • Pregnant or breastfeeding
  • Body mass index (BMI) of 35 or higher
  • Expected difficult airway during intubation

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single day (perioperative period)

Participants receive a single intravenous dose of either labetalol or lignocaine 3 minutes before laryngoscopy during laparoscopic cholecystectomy to mitigate hemodynamic responses.

1 treatment visit (in-person during surgery)

Follow-up

Duration - Approximately 1 hour post-treatment

Participants are monitored for approximately 1 hour after induction for heart rate, blood pressure changes, and any adverse events.

1 post-operative monitoring visit (in-person)

Trial Site Locations

Total: 1 location

1

Hayatabad Med Complex

Peshawar, Khyber Pakhtunkhwa, Pakistan, 25000

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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