A Study To Compare Efficacy Of Dexmedetomidine And Midazolam For Sedation And Reduction Of Dose Of Propofol In Minor Gynaecological Day Care Surgeries
- Conditions
- Gynaecological patients
- Registration Number
- CTRI/2018/04/013106
- Lead Sponsor
- NA
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Female
- Target Recruitment
- 150
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.
- 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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method additional dose of propofol required, sedation scores and recovery characteristics. two hours
- Secondary Outcome Measures
Name Time Method Hemodynamic parameters and side effects of study drug two hours
Trial Locations
- Locations (1)
SGRDIMSR
🇮🇳Amritsar, PUNJAB, India
SGRDIMSR🇮🇳Amritsar, PUNJAB, IndiaDr Ruchi GuptaPrincipal investigator9464091324drruchisgrd@gmail.com