Intravenous labetalol versus lignocaine to reduce heart rate and blood pressure spikes during intubation for laparoscopic gallbladder removal
Comparative Efficacy of Intravenous Labetalol and Lignocaine in Mitigating Hemodynamic Responses to Laryngoscopy During Laparoscopic Cholecystectomy: A Randomized Controlled Trial
This test will try a single IV dose of labetalol or lignocaine given before intubation to see which better prevents sudden heart rate and blood pressure rises in adults having elective laparoscopic gallbladder surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Lady Reading Hospital, Pakistan Government |
| Locations | 1 site (Peshawar, Khyber Pakhtunkhwa) |
| Trial ID | NCT07192081 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial at Hayatabad Medical Complex in Peshawar will randomly assign 116 adults undergoing elective laparoscopic cholecystectomy to receive either IV labetalol (0.25 mg/kg) or IV lignocaine (1.5 mg/kg) three minutes before laryngoscopy. The primary outcome is maintaining heart rate and mean arterial pressure within ±20% of baseline during and after intubation, with secondary recordings of perioperative blood pressure trends, intubation details, rescue medications, and adverse events. Eligible participants are ASA I–II adults aged 18–60 who provide consent, with exclusions for current antihypertensive therapy, significant cardiovascular or systemic disease, pregnancy, high BMI, or predicted difficult airway. The trial directly compares two commonly used peri-intubation drugs to inform safer anesthetic choices.
Who should consider this trial
Good fit: Adults aged 18 to 60 with ASA physical status I or II scheduled for elective laparoscopic cholecystectomy who are not on antihypertensive medications and can give informed consent.
Not a fit: People with significant cardiovascular, renal, hepatic, or endocrine disease, those on antihypertensives, pregnant or lactating patients, those with BMI ≥35, or those with an anticipated difficult airway are excluded and may not benefit from the study's findings.
Why it matters
Potential benefit: If successful, the results could help anesthesiologists choose the safer and more effective drug to keep heart rate and blood pressure stable during intubation and reduce perioperative cardiovascular risk.
How similar studies have performed: Both labetalol and IV lignocaine have been shown in prior studies to blunt intubation-related sympathetic surges, but direct head-to-head evidence specifically in laparoscopic cholecystectomy is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Peshawar, Khyber Pakhtunkhwa
- Hayatabad Med Complex — Peshawar, Khyber Pakhtunkhwa, Pakistan (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.