Comparison of oral Tramadol and oral Tapentadol as pre-emptive analgesic on post operative analgesia in laparoscopic cholecystectomy under general anaesthesia
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- 1. To assess and compare the post laparoscopic cholecystectomy analgesia after use of oral
研究概览
简要总结
This study aims to evaluate and compare the analgesic efficacy of oral Tramadol and Tapentadol when administered preemptively prior to anaesthesia induction in patients undergoing laparoscopic cholecystectomy. the objective is to determine which agent provides superior postoperative pain control. Pain intensity will be assessed using the Visual Analogue Scale (VAS), ranging from 0 (no pain ) to 10 (worst imaginable pain ), at specified postoperative intervals: immediately upon arrival at PACU and at 2, 6, 24 hour post operatively. the study will also evaluate the incidence of adverse effects, time of first rescue analgesia, and overall tolerability profile of each medication. Furthermore, perioperative hemodynamic parameters - including heart rate, systolic and diastolic blood pressure, mean arterial pressure, oxygen saturation (SpO2), end tidal carbon dioxide (EtCO2) - will be monitored at pre defined intraoperative and postoperative time points to assess physiological stability and potential drug related influences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA class I or II
- •Age: 18 to 70 years, either sex
- •Body mass index (BMI) of 18-35 kg/m2
- •Patients undergoing elective cholecystectomy under general anaesthesia.
排除标准
- •Major co-existing medical illness (especially severe asthma/COPD, repeat hernia surgery, epilepsy, uncontrolled hypertension or diabetes, liver or renal disease)
- •Patients with paralytic ileus, patients on antidepressants (to avoid risk of developing serotonin syndrome)
- •Known hypersensitivity to any of the study medications
- •Patients that had conversion to open surgery after laparoscopic visualization.
- •Known opioid abusers and patients on opioid antagonist.
结局指标
主要结局
1. To assess and compare the post laparoscopic cholecystectomy analgesia after use of oral
时间窗: After shifting to PACU for postoperative pain, sedation, nausea and vomiting at 0 hour, 2 hours, 6 hours and after 24 hours post-surgery.
Tramadol or oral Tapentadol preemptively before induction of anaesthesia. using Visual
时间窗: After shifting to PACU for postoperative pain, sedation, nausea and vomiting at 0 hour, 2 hours, 6 hours and after 24 hours post-surgery.
Analogue Scale (0- 10).
时间窗: After shifting to PACU for postoperative pain, sedation, nausea and vomiting at 0 hour, 2 hours, 6 hours and after 24 hours post-surgery.
2. To compare the adverse effects after use of oral Tramadol or oral Tapentadol
时间窗: After shifting to PACU for postoperative pain, sedation, nausea and vomiting at 0 hour, 2 hours, 6 hours and after 24 hours post-surgery.
preemptively before induction of anaesthesia in patients of laparoscopic cholecystectomy.
时间窗: After shifting to PACU for postoperative pain, sedation, nausea and vomiting at 0 hour, 2 hours, 6 hours and after 24 hours post-surgery.
3. Time of rescue analgesia administered
时间窗: After shifting to PACU for postoperative pain, sedation, nausea and vomiting at 0 hour, 2 hours, 6 hours and after 24 hours post-surgery.
次要结局
- To compare the hemodynamic parameters like heart rate (HR), systolic blood pressure((SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), pulse oximetry)
研究者
Manpreet Kaur
GMCH, Sector 32, Chandigarh