A randomised controlled trial to compare the effect of carbon dioxide insufflation at different rates on hemodynamic parameters during laparoscopic surgery
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 1. Mean arterial pressure immediately after achieving target intra-abdominal pressure (T2).
研究概览
简要总结
The present study will be a randomized, double arm, parallel group triple blind active controlled trial and will be conducted at Department of Anesthesiology and Critical care at Maharaja Agrasen Medical College, Agroha after approval from institutional ethical committee.
To estimate Mean arterial pressure immediately after achieving target intra-abdominal pressure (T2).
To estimate Heart rate immediately after achieving target intra-abdominal pressure (T2).
Secondary objective of the study will be-
To assess Shoulder pain one hour post-operatively using Visual Analog Scale (VAS) score
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •American Society of Anaesthesiologist (ASA) classification I-II.
- •18-60 years old patients undergoing elective laparoscopic surgery willing to participate in study.
排除标准
- •Patient refusal.
- •Patients for emergency laparoscopy.
- •Hypertensive patients.
- •Patients receiving sympathomimetic/sympatholytic medications.
结局指标
主要结局
1. Mean arterial pressure immediately after achieving target intra-abdominal pressure (T2).
时间窗: every 2 minutes upto 10 minutes after attainment of target pressure
2. Heart rate immediately after achieving target intra-abdominal pressure (T2).
时间窗: every 2 minutes upto 10 minutes after attainment of target pressure
次要结局
- Shoulder pain one hour post-operatively using Visual Analog Scale (VAS) score.(The shoulder pain will be assessed using the Visual Analog Scale (VAS), with 0 being no pain and 10 being the worst possible pain, after 1 hour of completion of surgery)
研究者
Dr Amit
Maharaja Agrasen Medical College Agroha District Hisar