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临床试验/CTRI/2018/04/013106
CTRI/2018/04/013106招募中不适用

A Study To Compare Efficacy Of Dexmedetomidine And Midazolam As Premedicants For Sedation And Propofol Sparing Effect In Minor Gynaecological Day Care Surgeries

NA1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2016年6月4日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
additional dose of propofol required, sedation scores and recovery characteristics.

研究概览

简要总结

Ambulatory surgery is  continually evolving speciality in majority of surgical procedures. Dexmedetomidine and midazolam are newer adjuvants for sedation and reducing the dose of anaesthetic agents. Aim of this study was to compare the sedative and propofol sparing effect of dexmedetomidine and midazolam in minor gynaecological day care fitness score were studied as primary outcomes. Hemodynamic parameters and side effects were evaluated as secondary outcomes. Results*:* Sedation score was statistically highly significant between group A and B (p<0.001). Between group A and C, it was statistically significant (p <0.05), however score was non significant  between groups B and C (p  >0.05). During recovery at 120 minutes after surgery, score 5 was achieved equally by all  three groups which was found to be statistically  insignificant (p > 0.05). Mean dose of additional propofol used, was less in group A (14±9.25) than B (25±5.40) and C (53±10.96). On intergroup comparison between all three groups, it was found to be statistically highly significant (p<0.001). Comparison of BIS values between group A and C and group B and C were highly significant p<0.001. However, it was statistically significant between group A and B (p <0.05). Aldrete scoring and Street Fitness Scores were highly significant between groups A and B, B and C and also between group A and C (p<0.001). No significant hemodynamic derangements and side effects were noted in any of three groups. Conclusion : dexmedetomidine had good sedation and better recovery characteristics than midazolam. BIS monitoring was helpful in maintaining surgeries under BIS monitored general anaesthesia. Material and methods*:*  a prospective randomized placebo controlled study was conducted on 150 physical status ASA I and II gynaecological patients between 18 to 50 years were allocated into 3 groups of fifty each. Group A received IV dexmedetomidine 0.1 µ.kg-1, group B received IV midazolam 0.04 mg.kg-1 and group C received normal saline 10 minutes before induction. Observers assessment for activity and sedation score (OAA/S), additional dose of propofol required, recovery characteristics using aldrete and street depth of anesthesia thereby reducing requirement of other anesthetic agents.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Patients undergoing elective minor gynaecological day care surgeries of <1 hour duration like tubectomy, dilatation & curettage, suction & evacuation, endometrial biopsies, cervical biopsies, polypectomies, cervical stitching etc.

排除标准

  • 1 Patients on alpha adrenergic receptor blocker 2 Patient with known hypersensitivity to study drug 3 Compromised cardiac patients, renal or hepatic disease patients 4 Patients with some psychiatric history.
  • 5 Patients with neurological disease with motor and sensory deficit.
  • •Patient allergic to egg •Pregnant patients.

结局指标

主要结局

additional dose of propofol required, sedation scores and recovery characteristics.

时间窗: two hours

次要结局

  • Hemodynamic parameters and side effects of study drug(two hours)

研究者

发起方
NA
申办方类型
Private medical college

研究点 (1)

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