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临床试验/CTRI/2021/06/034291
CTRI/2021/06/034291尚未招募不适用

Evaluating the effect of Duloxetine premedication on postoperative analgesic requirement in patients undergoing laparoscopic cholecystectomy surgery

Sharda Hospital School of Medical Sciences Research1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年6月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To evaluate the analgesic efficacy of duloxetine premedication on post operative analgesic requirement in laparoscopic cholecystectomies using VAS score(Visual Analogue Scale)

研究概览

简要总结

.Despite recent advances in minimal invasive surgery, postoperative pain controlremains a challenge for both surgeons and anesthesiologists and plays an importantrole in accelerating the improvement of surgical patients’ general condition. Thelaparoscopy technique is a revolutionary in surgical field, presenting severaladvantages such as smaller surgical incisions, less bleeding, shorter hospitalizationtime, and lower hospital costs. However, postoperative pain is still a complication thatresults in an unpleasant experience and delayed discharge.

Considering the benefits of the thiophene derivative ‘Duloxetine’ in suppressing the postoperative pain response, we will be supplementing our general anesthesia technique with preoperative Duloxetine supplementation anticipating better  postoperative pain status of patients undergoing laparoscopic cholecystectomy in the perioperative period and comparing with the control group where the conventional protocols of general anaesthesia & pain management will be followed.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • All the elective cases of Laparoscopic Cholecystectomy of ASA I or II, scheduled for general anesthesia.

排除标准

  • Patient refusal
  • Patients with any known history of cardiovascular diseases 3.Patients with known case of hepatic and renal disease 4.Patients with known history of substance abuse 5.A chronic opioid abuser(>3 months), being on chronic Gabapentin or Pregabalin(>3months) 6.Patients on antidepressant drugs and patients with psychiatric disorders 7.Anticipitated difficult airway on preoperative assessment 8.Patients converted to open cholecystectomy from laparoscopic cholecystectomy
  • Patients in whom drain placement has been done 10.BMI>30 11.Pregnant and lactating females 12.History of allergy to any of the drug to be administered.

结局指标

主要结局

To evaluate the analgesic efficacy of duloxetine premedication on post operative analgesic requirement in laparoscopic cholecystectomies using VAS score(Visual Analogue Scale)

时间窗: 12 hours

次要结局

  • a) Total dose of first and second rescue analgesic (InjParacetamol&InjTramadol) consumption in post operative period.(b) Ramsey Sedation Score in Preoperative & postoperative period)

研究者

发起方
Sharda Hospital School of Medical Sciences Research
申办方类型
Private medical college

研究点 (1)

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