Comparison of Dexmedetomidine-Ketamine-Propofol combination versus Ketamine-Propofol combination for recovery characteristics in gynecological procedure: A randomized controlled study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- To compare post procedure recovery characteristics for:
研究概览
简要总结
Moderate sedation is required for various short procedure such as endoscopy, gynaecological procedure, ECT, fracture reduction, incision and drainage, debridement etc. to ease discomfort while intervention with minimization of recovery agitations in variety of patients. ASA 1,2 and 3 undergoing gynaecological procedure of age between 18 to 65 years with BMI < 30 kg/m^2 will be randomized to receive Dexmedetomidine-ketamine-propofol (n=32) or Ketamine-propofol (n=32) to compare recovery profile. The aim of this study was to evaluate and compare the ketamine-propofol with and without dexmedetomidine for post procedure recovery characteristics in patients undergoing gynaecological procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.patients posted for gynaecological procedure having procedure time less than 30 minutes 2.ASA I, II, III 3.age/ sex 18-65 years, female 4.BMI less than 30kg/ m2 5.patient belonging to mallamppati grading I- II on airway assessment.
排除标准
- •Inability or refusal to follow the study protocol
- •Patient with uncontrolled medical conditions like hypertension, diabetes mellitus, renal failure, active seizure, raised intracranial pressure etc.
- •Patient with sever cardiovascular or pulmonary pathology, sever renal or liver disorders.
- •Patient having neuro psychiatric disorders, H/o drug or alcohol abuse etc.
结局指标
主要结局
To compare post procedure recovery characteristics for:
时间窗: At end of procedure
a)Recovery time (Time to achieve University of Michigan sedation scale 1 (UMSS 1))
时间窗: At end of procedure
b)Post procedure Emergence agitation: yes/no
时间窗: At end of procedure
c)Over all patient satisfaction score
时间窗: At end of procedure
次要结局
- 1.To monitor stability by monitoring systolic blood pressure, diastolic blood pressure, mean arterial pressure, pulse rate, peripheral oxygen saturation during procedure & maintain them within 20% of baseline value(2.To record total requirement of incremental dose of ketamine-propofol during procedure)
研究者
Girish Vadhel
Baroda Medical College