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

NCT07192081 | Recruiting

• 1 other identifier: CPSP/REU/ANS-2023-021-3099
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intubation; Anesthesia; Laparoscopic Cholecystectomy; Hemodynamic Response to Laryngoscopy

Keywords

Attenuation of Sympathetic Response; Perioperative Management; Randomized Controlled Trial; Endotracheal Intubation; Hemodynamic Stability; Lignocaine; Labetalol

Outcome Measures

Primary Outcomes (1)

• Change in Systolic Blood Pressure (SBP) Following Laryngoscopy

  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.

  From 5 minutes before induction to 10 minutes after intubation.

Secondary Outcomes (4)

• Change in Diastolic Blood Pressure (DBP)

  From 5 minutes before induction to 10 minutes after intubation.

• Change in Mean Arterial Pressure (MAP)

  From 5 minutes before induction to 10 minutes after intubation..

• Change in Heart Rate

  From 5 minutes before induction to 10 minutes after intubation.

• Incidence of Adverse Events

  From induction through recovery (approx. 1 hour)

Study Arms (2)

Labetalol Group

EXPERIMENTAL

Patients in this arm will receive intravenous labetalol at a dose of 0.25 mg/kg over 60 seconds, 3 minutes prior to laryngoscopy and intubation.

Drug: Labetalol

Lignocaine Group

ACTIVE COMPARATOR

Patients in this arm will receive intravenous lignocaine at a dose of 1.5 mg/kg over 60 seconds, 3 minutes prior to laryngoscopy and intubation.

Drug: Lignocaine

Interventions

Labetalol DRUG

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

Labetalol Group

Lignocaine DRUG

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

Lignocaine Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Waseem Ullah: lead
• Hayatabad Medical Complex: collaborator

Study Sites (1)

Hayatabad Med Complex

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

RECRUITING

MeSH Terms

Interventions

Labetalol; Lidocaine

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Salicylamides; Amides; Amines; Acetanilides; Anilides; Aniline Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will be blinded to group allocation. The anesthesiologist administering the intervention will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Registrar

Model Details: Single-center, randomized, single-blind, parallel-arm trial comparing IV labetalol and lignocaine in adult patients undergoing laparoscopic cholecystectomy.

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 25, 2025
• Study Start: June 5, 2025
• Primary Completion: January 4, 2026
• Study Completion: February 28, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)