A Randomized Controlled Trial to Evaluate the Efficacy of Intraperitoneal Instillation of Ropivacaine with Dexmedetomidine versus Bupivacaine with Dexmedetomidine for Postoperative Analgesia in Patients Undergoing Laparoscopic Cholecystectomy"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- The time duration (in hours)
研究概览
简要总结
This randomized, double-blind clinical trial aims to compare the analgesic efficacy of intraperitoneal instillation of 0.25% bupivacaine versus 0.25% ropivacaine, both combined with dexmedetomidine (0.5 mcg/kg), in patients undergoing elective laparoscopic cholecystectomy. Conducted at KIMS, Bhubaneswar from August 2025 to July 2027, the study includes 92 ASA I/II patients aged 18–65 years. The primary outcome is the time to first rescue analgesia; secondary outcomes include total analgesic requirement, VAS pain scores, heart rate, and MAP over 24 hours. The study follows standardized anesthesia protocols and pain assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA grade I or II Age between 18 and 65 years Hemodynamically stable Undergoing elective laparoscopic cholecystectomy Provided written informed consent.
排除标准
- •Emergency procedures Significant comorbidities (neurological, cardiac, respiratory, metabolic, hepatic, renal) Coagulation disorders Known allergy to study drugs.
结局指标
主要结局
The time duration (in hours)
时间窗: From the end of surgery (trocar removal) until the first patient request for rescue analgesia, within the first 24 hours postoperatively.
from the completion of
时间窗: From the end of surgery (trocar removal) until the first patient request for rescue analgesia, within the first 24 hours postoperatively.
surgery to the time patient
时间窗: From the end of surgery (trocar removal) until the first patient request for rescue analgesia, within the first 24 hours postoperatively.
requested for first rescue
时间窗: From the end of surgery (trocar removal) until the first patient request for rescue analgesia, within the first 24 hours postoperatively.
analgesic medication.
时间窗: From the end of surgery (trocar removal) until the first patient request for rescue analgesia, within the first 24 hours postoperatively.
次要结局
- 1 .The total rescue analgesic(dose requirements in first 24)
研究者
Dr Prakriti Choudhury
Pradyumna Bal Memorial Hospital, Kalinga Institute of Medical Sciences