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临床试验/NCT07693621
NCT07693621招募中不适用

Intraperitoneal Instillation of Dexmedetomidine Versus Magnesium Sulphate as Adjuvants to Bupivacaine in Laparoscopic Cholecystectomy

Alexandria University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年5月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Quality of recovery

研究概览

简要总结

Although both dexmedetomidine and magnesium sulphate have been individually evaluated as adjuvants to local anesthetics, direct comparisons between the two agents in intraperitoneal instillation during laparoscopic cholecystectomy remain limited. Understanding their relative efficacy and safety could provide valuable guidance for optimizing perioperative analgesia in these patients.

详细描述

Laparoscopic cholecystectomy is one of the most commonly performed minimally invasive procedures worldwide. Despite its advantages over open surgery, such as shorter hospital stay and faster recovery, patients frequently experience postoperative pain, which can delay mobilization, prolong hospital stay, and reduce overall satisfaction [1]. Effective pain management is therefore a critical component of enhanced recovery after laparoscopic cholecystectomy [2].

Intraperitoneal instillation of local anesthetics has been widely used as part of multimodal analgesia to reduce postoperative pain [3]. Bupivacaine, a long-acting amide local anesthetic, is commonly employed due to its favorable safety profile and prolonged duration of action. However, when used alone, its efficacy in providing sustained analgesia is limited, prompting the exploration of adjuvants that may potentiate its effect [4].

Dexmedetomidine, a highly selective α2-adrenergic receptor agonist, has been shown to enhance the analgesic efficacy of local anesthetics by prolonging sensory blockade and providing sedative as well as opioid-sparing effects. Magnesium sulphate, an N-methyl-D-aspartate (NMDA) receptor antagonist, has also been investigated as an adjuvant, with evidence suggesting its role in reducing central sensitization and postoperative pain [5].

Aim of the work The present study aims to compare the analgesic efficacy of intraperitoneal bupivacaine combined with dexmedetomidine versus bupivacaine combined with magnesium sulphate in patients undergoing laparoscopic cholecystectomy.

Primary Outcomes:

研究设计

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

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

  • Patients aged 18-60 years
  • ASA physical status I-II
  • scheduled for elective laparoscopic cholecystectomy under general anesthesia.

排除标准

  • Known hypersensitivity to study drugs
  • history of cardiac arrhythmias or conduction abnormalities
  • severe hepatic/renal impairment
  • chronic opioid or analgesic use
  • pregnancy
  • conversion to open surgery
  • drain insertion.

结局指标

主要结局

Quality of recovery

时间窗: postoperative day 1

QoR-15 questionnaire

Postoperative pain scores (VAS)

时间窗: postoperative day 1

at rest , at movement

次要结局

  • Total postoperative opioid consumption(postoperative day 1)
  • Time to first analgesic request.(postoperative day1)
  • Incidence of postoperative nausea and vomiting(postoperative day 1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

sarah mohamed

lecturer

Alexandria University

研究点 (1)

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