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Идёт набор NCT07192081

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

Без фазы С лечением Intubation Anesthesia Laparoscopic Cholecystectomy Hemodynamic Response to Laryngoscopy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Labetalol, Lignocaine.
Кому может быть актуально
Состояния в реестре: Intubation, Anesthesia, Laparoscopic Cholecystectomy, Hemodynamic Response to Laryngoscopy. Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Пакистан
Следующий шаг
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Официальное название

Comparative Efficacy of Intravenous Labetalol and Lignocaine in Mitigating Hemodynamic Responses to Laryngoscopy During Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

  • Препарат Labetalol
    Labetalol 0.25 mg/kg intravenous bolus over 60 seconds, administered 3 minutes before laryngoscopy.
  • Препарат Lignocaine
    Lignocaine 1.5 mg/kg intravenous bolus over 60 seconds, administered 3 minutes before laryngoscopy.

Первичные конечные точки

  • Change in Systolic Blood Pressure (SBP) Following Laryngoscopy [Срок оценки: From 5 minutes before induction to 10 minutes after intubation.]
Вторичные конечные точки (4)
  • Change in Diastolic Blood Pressure (DBP) [Срок оценки: From 5 minutes before induction to 10 minutes after intubation.]
  • Change in Mean Arterial Pressure (MAP) [Срок оценки: From 5 minutes before induction to 10 minutes after intubation..]
  • Change in Heart Rate [Срок оценки: From 5 minutes before induction to 10 minutes after intubation.]
  • Incidence of Adverse Events [Срок оценки: From induction through recovery (approx. 1 hour)]

Критерии участия

Критерии включения

  • ASA Grade I and II
  • Age 18 to 60 years
  • Elective laparoscopic cholecystectomy
  • Both genders
  • Informed consent given

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Пакистан · 1 центр
  • Hayatabad Med Complex — Peshawar

Идентификаторы

NCT: NCT07192081 · CPSP/REU/ANS-2023-021-3099

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗