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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorDr. Waseem Ullah

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ASA Grade I and II

Age 18 to 60 years

Elective laparoscopic cholecystectomy

Both genders

Disqualifiers

Hypersensitivity to labetalol/lignocaine

Hypertensive on antihypertensives

ASA Grade III or more

Cardiovascular, renal, hepatic, or endocrine issues

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

116 Participants
are divided into 2 treatment groups
Group A: Labetalol GroupExperimental treatment 1 intervention
Group B: Lignocaine GroupActive comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Change in Diastolic Blood Pressure (DBP)

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

Time frame
From 5 minutes before induction to 10 minutes after intubation.
2

Change in Mean Arterial Pressure (MAP)

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

Time frame
From 5 minutes before induction to 10 minutes after intubation..
3

Change in Heart Rate

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

Time frame
From 5 minutes before induction to 10 minutes after intubation.
4

Incidence of Adverse Events

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr. Waseem Ullah

Lead sponsor

Lady Reading Hospital, Pakistan

Sponsor institution

Hayatabad Medical Complex

Collaborator