| CTRI Number |
CTRI/2018/04/013106 [Registered on: 09/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
03/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study To Compare Efficacy Of Dexmedetomidine And Midazolam For Sedation And Reduction Of Dose Of Propofol In Minor Gynaecological Day Care Surgeries |
|
Scientific Title of Study
|
A Study To Compare Efficacy Of Dexmedetomidine And Midazolam As Premedicants For Sedation And Propofol Sparing Effect In Minor Gynaecological Day Care Surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ruchi Gupta |
| Designation |
Professor and Head Dept Of Anaesthesia |
| Affiliation |
Sri Guru Ram Das Medical Colege |
| Address |
Dept Of Anaesthesiology and Critical Care
Sri Guru Ram Das Institute Of Medical Sciences And Research Vallah Amritsar
Dept Of Anaesthesiology and Critical Care
Sri Guru Ram Das Institute Of Medical Sciences And Research Vallah Amritsar
Amritsar
PUNJAB
143501
India |
| Phone |
9814320805 |
| Fax |
|
| Email |
drruchisgrd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anita Kumari |
| Designation |
Professor Dept Of Anaesthesia |
| Affiliation |
Sri Guru Ram Das Medical Colege |
| Address |
Dept Of Anaesthesiology and Critical Care
Sri Guru Ram Das Institute Of Medical Sciences And Research Vallah Amritsar
Dept Of Anaesthesiology and Critical Care
Sri Guru Ram Das Institute Of Medical Sciences And Research Vallah Amritsar
Amritsar
PUNJAB
143501
India |
| Phone |
9815632909 |
| Fax |
|
| Email |
kumarianitadr1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti Vidhan |
| Designation |
PG Resident |
| Affiliation |
Sri Guru Ram Das Medical Colege |
| Address |
Shri Guru Ram Dass Medical College Institute Of Medical Sciences And Research ,
Dept Of Anaesthesia
Vallah , Amritsar
Shri Guru Ram Dass Medical College Institute Of Medical Sciences And Research ,
Dept Of Anaesthesia
Vallah , Amritsar
Amritsar
PUNJAB
146001
India |
| Phone |
9464091324 |
| Fax |
|
| Email |
vidhanjyoti@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri guru ram dass Medical Institute of health and research |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| Nil |
Nil |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ruchi Gupta |
SGRDIMSR |
Dept Of Gynaecology And Obstetrics. Sri Guru Ram Das Medical Institute Of Science And reseach. Vallah Amritsa
Amritsar
PUNJAB |
9464091324
drruchisgrd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethic committee SGRDIMSR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Gynaecological patients, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| additional dose of propofol required, sedation scores and recovery characteristics. |
two hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic parameters and side effects of study drug |
two hours |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/04/2016 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |