Randomized Controlled Clinical Trial to Examine the Efficacy of Oral Midazolam in Post Operative Pain Reduction in Patients Undergoing Laparoscopic Cholecystectomy

F. Siddiqui, M. Umer, Hiba Moazzam, Sarosh ., Umar Soomro, Shahtaj A Shah
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Abstract

Background: Stressful conditions like surgery and anesthesia trigger neuroendocrine pathway activation, which can have dangerous hemodynamic effects on the patient. One method for minimizing these hemodynamic consequences is maintaining an optimum level of anesthesia. Another option is giving patients a pharmaceutical formulation that modifies how anesthetic agents react. Objective: The current study sought to determine if preoperative oral midazolam could reduce postoperative pain scores and the occurrence of Rescue Analgesia in patients undergoing laparoscopic cholecystectomy. Methods: This is a single-blinded randomized controlled study conducted at the Surgery department of Jinnah Medical College Hospital, Korangi Karachi, on patients undergoing laparoscopic cholecystectomy. Through simple random sampling, participants were divided into two study groups, control (n=32) and 7.5mg receiving preoperative oral midazolam-intervention group. After surgery, the VAS pain score in both group participants was measured at 2, 8, 12, and 24 hours. The frequency of rescue analgesia and duration of hospital stay was also observed. Standard deviation, mean, chi-square test, and T-test was performed to determine the variation in both groups by using SPSS version 26. The P value ≤0.005 was measured significant. Results: No significant difference in the postoperative pain score after oral administration of midazolam in the intervention group compared to the control group at 2, 12, and 24 hrs intervals. Except at 8-hour intervals, a significant change of 0.004 was observed in both study groups. A significant variation of 0.008 was observed in the duration of hospital stay in the intervention group when compared with the control group. Lastly, in the present study, no significant difference in the frequency of rescue analgesics was observed in both study groups. Practical implication: This study will help out to determine the right dosage of oral midazolam which might effectively be used in managing post-operative pain in laparoscopic cholecystectomy patients. Conclusion: Orally administeredmidazolam was not efficient in lowering the pain score in patients undergoing laparoscopic cholecystectomy. Keywords: Midazolam, Post-operative pain, Laparoscopic cholecystectomy, Local anesthetics
观察口服咪达唑仑对腹腔镜胆囊切除术患者术后疼痛减轻效果的随机对照临床试验
背景:手术和麻醉等应激条件会触发神经内分泌通路激活,这可能对患者产生危险的血流动力学影响。减少这些血流动力学后果的一种方法是维持最佳麻醉水平。另一种选择是给病人一种改变麻醉剂反应的药物配方。目的:本研究旨在确定术前口服咪达唑仑是否能降低腹腔镜胆囊切除术患者术后疼痛评分和抢救性镇痛的发生。方法:这是一项在卡拉奇Korangi真纳医学院医院外科对腹腔镜胆囊切除术患者进行的单盲随机对照研究。通过简单随机抽样,将参与者分为对照组(n=32)和7.5mg术前口服咪达唑仑干预组。术后2、8、12、24小时分别测量两组受试者的VAS疼痛评分。观察两组患者抢救镇痛的频率和住院时间。采用SPSS version 26进行标准差、均数、卡方检验和t检验。P值≤0.005为显著性。结果:干预组口服咪达唑仑术后疼痛评分与对照组间隔2、12、24 h无显著差异。除间隔8小时外,在两个研究组中均观察到0.004的显著变化。干预组住院时间与对照组比较差异显著,为0.008。最后,在本研究中,两组患者使用镇痛药的频率没有显著差异。实际意义:本研究将有助于确定口服咪达唑仑的正确剂量,从而有效地控制腹腔镜胆囊切除术患者术后疼痛。结论:口服咪达唑仑不能有效降低腹腔镜胆囊切除术患者的疼痛评分。关键词:咪达唑仑,术后疼痛,腹腔镜胆囊切除术,局麻药
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