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

Not Applicable

Recruiting

• Conditions: Intubation; Anesthesia; Laparoscopic Cholecystectomy; Hemodynamic Response to Laryngoscopy
• Interventions: Drug: Labetalol; Drug: Lignocaine

• Registration Number: NCT07192081
• Lead Sponsor: Dr. Waseem Ullah

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.

Detailed Description

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.

Study Timeline

• Study Start: 2025-06-05
• Status Verified: 2025-09
• Study First Submitted: 2025-09-15
• Study First Submitted QC: 2025-09-21
• Last Update Submitted: 2025-09-21
• Study First Posted: 2025-09-25
• Last Update Posted: 2025-09-25
• Primary Completion: 2026-01-04
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Labetalol Group	Labetalol	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.
Lignocaine Group	Lignocaine	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.

Primary Outcome Measures

Name	Time	Method
Change in Systolic Blood Pressure (SBP) Following Laryngoscopy	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 Outcome Measures

Name	Time	Method
Change in Diastolic Blood Pressure (DBP)	From 5 minutes before induction to 10 minutes after intubation.	To assess diastolic blood pressure response post-laryngoscopy between both groups.
Change in Mean Arterial Pressure (MAP)	From 5 minutes before induction to 10 minutes after intubation..	To compare MAP variations post-induction and post-laryngoscopy.
Change in Heart Rate	From 5 minutes before induction to 10 minutes after intubation.	To evaluate the impact of interventions on HR response to laryngoscopy.
Incidence of Adverse Events	From induction through recovery (approx. 1 hour)	Number of participants experiencing side effects such as bradycardia, hypotension, or allergic reaction.

Trial Locations

Locations (1)

Hayatabad Med Complex; 🇵🇰 Peshawar, Khyber Pakhtunkhwa, Pakistan