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NCT Number: NCT07192081

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

Laryngoscopy and intubation during laparoscopic cholecystectomy often cause sudden increases in heart rate and blood pressure, which can be harmful in some patients. Medications such as labetalol and lignocaine are commonly used to reduce this hemodynamic response. This randomized controlled trial at Hayatabad Medical Complex, Peshawar, will compare intravenous labetalol (0.25 mg/kg) and lignocaine (1.5 mg/kg), administered 3 minutes before laryngoscopy. A total of 116 patients undergoing elective laparoscopic cholecystectomy will be randomly assigned to either drug group. The primary goal is to determine which drug is more effective in keeping heart rate and mean arterial pressure within ±20% of baseline during and after intubation. The study will also record blood pressure trends, intubation details, rescue medications, and adverse events such as bradycardia or hypotension. Results will help guide anesthesiologists in selecting the safer and more effective option to maintain cardiovascular stability during surgery.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hayatabad Med Complex

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location status: Recruiting

Location contact

Shahkar Khan Trainee Medical Officer, Mbbs

CONTACT

[email protected]

92 310 1185828

About this study

Laparoscopic cholecystectomy is the standard surgical treatment for symptomatic gallstones. However, laryngoscopy and endotracheal intubation during anesthesia often trigger a sympathetic surge, resulting in tachycardia and hypertension. These hemodynamic changes, although short-lived, may increase perioperative risk, especially in patients with limited cardiovascular reserve.

Labetalol, a combined α1- and β-adrenergic antagonist, reduces both heart rate and arterial pressure by blunting sympathetic activity. Lignocaine, an amide local anesthetic, also exhibits sympatholytic effects when given intravenously. Both agents are widely used in anesthesia practice, but direct head-to-head evidence in the setting of laparoscopic cholecystectomy remains limited.

This randomized controlled study will evaluate and compare the efficacy of intravenous labetalol and lignocaine in attenuating pressor and tachycardic responses to laryngoscopy. The trial will include adult ASA I patients scheduled for elective laparoscopic cholecystectomy. Participants will be randomly assigned to receive either labetalol 0.25 mg/kg or lignocaine 1.5 mg/kg intravenously, 3 minutes before laryngoscopy. Hemodynamic variables (heart rate, systolic, diastolic, and mean arterial pressures) will be tracked peri-intubation. The occurrence of adverse events such as bradycardia, hypotension, or allergic reactions will also be monitored.

By directly comparing these two commonly used drugs in a controlled setting, the study aims to clarify which provides superior cardiovascular stability during airway instrumentation. Findings will contribute to evidence-based guidance for anesthesiologists in selecting pharmacologic strategies that minimize perioperative risk in laparoscopic surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA Grade I and II
  • Age 18 to 60 years
  • Elective laparoscopic cholecystectomy
  • Both genders
  • Informed consent given

Exclusion criteria

  • Hypersensitivity to labetalol/lignocaine
  • Hypertensive on antihypertensives
  • ASA Grade III or more
  • Cardiovascular, renal, hepatic, or endocrine issues
  • Pregnant/lactating
  • BMI ≥ 35
  • Anticipated difficult airway

Treatment and study plan

labetalol

Drug

Labetalol 0.25 mg/kg intravenous bolus over 60 seconds, administered 3 minutes before laryngoscopy.

lignocaine

Drug

Lignocaine 1.5 mg/kg intravenous bolus over 60 seconds, administered 3 minutes before laryngoscopy.

Primary outcomes

  1. Change in Systolic Blood Pressure (SBP) Following Laryngoscopy

    Time frame: From 5 minutes before induction to 10 minutes after intubation.

    To evaluate and compare the effect of intravenous labetalol and lignocaine on systolic blood pressure changes in response to laryngoscopy during induction for laparoscopic cholecystectomy.

Secondary outcomes

  1. Change in Diastolic Blood Pressure (DBP)

    Time frame: From 5 minutes before induction to 10 minutes after intubation.

    To assess diastolic blood pressure response post-laryngoscopy between both groups.

  2. Change in Mean Arterial Pressure (MAP)

    Time frame: From 5 minutes before induction to 10 minutes after intubation..

    To compare MAP variations post-induction and post-laryngoscopy.

  3. Change in Heart Rate

    Time frame: From 5 minutes before induction to 10 minutes after intubation.

    To evaluate the impact of interventions on HR response to laryngoscopy.

  4. Incidence of Adverse Events

    Time frame: From induction through recovery (approx. 1 hour)

    Number of participants experiencing side effects such as bradycardia, hypotension, or allergic reaction.

Sponsors and collaborators

Lead sponsor

Dr. Waseem Ullah

Other Gov

Collaborators

  • Hayatabad Medical Complex

Registry information

Official study title

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

Acronym: LAB-LIG RCT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 25, 2025
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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