An interventional study of Labetalol and Lignocaine in Intubation, Anesthesia and Laparoscopic Cholecystectomy, sponsored by Dr. Waseem Ullah. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-09-25.
Sponsored by Dr. Waseem Ullah · Not applicable, Interventional, and Treatment
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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.
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.
Dr. Waseem Ullah is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Labetalol 0.25 mg/kg intravenous bolus over 60 seconds, administered 3 minutes before laryngoscopy.
Lignocaine 1.5 mg/kg intravenous bolus over 60 seconds, administered 3 minutes before laryngoscopy.
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.
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.
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..
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.
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)
Plan to share: No — The individual participant data (IPD) will not be shared due to institutional policies, privacy concerns, and limitations in data-sharing infrastructure.
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Jan 2026, 6 months after the start.
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Studies of the drug tested here: Labetalol