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临床试验/NCT07192081
NCT07192081招募中不适用

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

Dr. Waseem Ullah1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2025年6月5日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
116
试验地点
1
主要终点
Change in Systolic Blood Pressure (SBP) Following Laryngoscopy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants and outcome assessors will be blinded to group allocation. The anesthesiologist administering the intervention will not be blinded.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Hypersensitivity to labetalol/lignocaine
  • Hypertensive on antihypertensives
  • ASA Grade III or more
  • Cardiovascular, renal, hepatic, or endocrine issues
  • Pregnant/lactating
  • Anticipated difficult airway

研究组 & 干预措施

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.

干预措施: Labetalol (Drug)

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.

干预措施: Lignocaine (Drug)

结局指标

主要结局

Change in Systolic Blood Pressure (SBP) Following Laryngoscopy

时间窗: From 5 minutes before induction to 10 minutes after intubation.

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.

次要结局

  • Change in Diastolic Blood Pressure (DBP)(From 5 minutes before induction to 10 minutes after intubation.)
  • Change in Mean Arterial Pressure (MAP)(From 5 minutes before induction to 10 minutes after intubation..)
  • Change in Heart Rate(From 5 minutes before induction to 10 minutes after intubation.)
  • Incidence of Adverse Events(From induction through recovery (approx. 1 hour))

研究者

发起方
Dr. Waseem Ullah
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Dr. Waseem Ullah

Registrar

Lady Reading Hospital, Pakistan

研究点 (1)

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