GABAPENTIN ATTENUATES THE PRESSOR RESPONSE TO DIRECT LARYNGOSCOPY AND TRACHEAL INTUBATION
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 144
- 主要终点
- Mean Arterial Pressure (MAP)
研究概览
简要总结
This study evaluates the effectiveness of oral gabapentin in reducing the pressor response (increased MAP, HR, and BP) during laryngoscopic intubation. It is a prospective, double-blind randomized controlled trial involving 144 patients undergoing elective surgery. Gabapentin 300 mg or placebo will be administered preoperatively, with hemodynamic parameters monitored before and after intubation. The study aims to determine if gabapentin attenuates the sympathetic stress response compared to placebo.
详细描述
Laryngoscopic tracheal intubation often triggers a significant sympathetic response, causing increased heart rate, blood pressure, and other hemodynamic changes, which can pose risks for patients with underlying cardiovascular or cerebrovascular conditions. While various methods and drugs have been employed to mitigate this pressor response, gabapentin-a GABA analog with multimodal effects-has shown promise in reducing such hemodynamic stress. This study aims to evaluate the effectiveness of oral gabapentin as a pretreatment to attenuate the sympathetic response during intubation.
The objective of this study is to compare the effectiveness of gabapentin versus placebo in reducing stress responses, such as mean arterial pressure (MAP), heart rate (HR), and blood pressure (BP), during general anesthesia with endotracheal intubation.
Study Design is Prospective, double-blind, randomized controlled trial and will be conducted in Department of Anesthesia, Liaquat National Hospital.
during 8 months. 144 patients (72 per group), calculated based on prior MAP data, with patients randomized into Gabapentin (Group G) and Placebo (Group P) Patients aged 18-59 years, ASA I or II, undergoing elective surgeries will be included.
Exclusion Criteria is difficult intubation, ASA III or higher, obesity, or use of antihypertensive or sedative drugs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I or II patients (American Society of Anesthesiologists Physical Status Classification).
- •Age between 18 and 59 years.
- •Scheduled for elective surgery under general anesthesia with endotracheal intubation.
排除标准
- •Anticipated difficult intubation.
- •ASA III or greater.
- •Patients with hiatus hernia or gastro-esophageal reflux disease (GERD).
- •Body weight more than 20% of ideal body weight.
- •Patients on antihypertensive drugs, sedatives, hypnotics, or antidepressants.
研究组 & 干预措施
Placebo Group (Group P): Participants receiving a placebo as a pre-treatment.
Placebo Group (Group P): Participants receiving a placebo as a pre-treatment.
干预措施: Placebo Oral Tablet (Other)
结局指标
主要结局
Mean Arterial Pressure (MAP)
时间窗: 2 minutes, and 5 minutes after laryngoscopy and tracheal intubation
The primary outcome is the change in MAP before intubation, 2 minutes, and 5 minutes after laryngoscopy and tracheal intubation. The focus is on whether Gabapentin maintains MAP within 20 mmHg of the patient's baseline reading.
次要结局
未报告次要终点
研究者
SYEDA AEMAN ZUBAIR
DR
Liaquat National Hospital & Medical College