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| Name | Class |
|---|---|
| Hayatabad Medical Complex | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Labetalol | Drug | Labetalol 0.25 mg/kg intravenous bolus over 60 seconds, administered 3 minutes before laryngoscopy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Diastolic Blood Pressure (DBP) | To assess diastolic blood pressure response post-laryngoscopy between both groups. | From 5 minutes before induction to 10 minutes after intubation. |
| Change in Mean Arterial Pressure (MAP) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hayatabad Med Complex | Recruiting | Peshawar | Khyber Pakhtunkhwa | 25000 | Pakistan |
The individual participant data (IPD) will not be shared due to institutional policies, privacy concerns, and limitations in data-sharing infrastructure.
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Single-center, randomized, single-blind, parallel-arm trial comparing IV labetalol and lignocaine in adult patients undergoing laparoscopic cholecystectomy.
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Participants and outcome assessors will be blinded to group allocation. The anesthesiologist administering the intervention will not be blinded.
| Lignocaine | Drug | Lignocaine 1.5 mg/kg intravenous bolus over 60 seconds, administered 3 minutes before laryngoscopy. |
|
To compare MAP variations post-induction and post-laryngoscopy.
| 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. | 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. | From induction through recovery (approx. 1 hour) |
| ID | Term |
|---|---|
| D007741 | Labetalol |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D012457 | Salicylamides |
| D000577 | Amides |
| D000588 | Amines |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000814 | Aniline Compounds |
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