| CTRI Number |
CTRI/2021/08/035523 [Registered on: 09/08/2021] Trial Registered Prospectively |
| Last Modified On: |
08/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to compare the the sedative drug combination dexmedetomidine plus ketamine and midazolam plus ketamine on patients undergoing short surgical procedures. |
|
Scientific Title of Study
|
Comparative evaluation of the combination of intravenous Ketamine Hydrochloride plus Dexmedetomidine Hydrochloride and Ketamine Hydrochloride plus Midazolam Hydrochloride in procedural sedation for short surgical procedures- A randomized controlled study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Seethal Ann Sunny |
| Designation |
Junior Resident |
| Affiliation |
Gajra Raja Medical College |
| Address |
Department Of Anaesthesiology
G.R Medical College, Gwalior
Gwalior
MADHYA PRADESH
474002
India |
| Phone |
9495280289 |
| Fax |
|
| Email |
seethalannsunny92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dilip Kothari |
| Designation |
Professor and Head of Department |
| Affiliation |
GR Medical College, Gwalior |
| Address |
Department of Anaesthesiology
GR Medical college, Gwalior
Gwalior
MADHYA PRADESH
474002
India |
| Phone |
9827217327 |
| Fax |
|
| Email |
drdilip_kothari@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dilip Kothari |
| Designation |
Professor and Head of Department |
| Affiliation |
Gajra Raja Medical College, Gwalior |
| Address |
Department of Anaesthesiology
GR Medical college, Gwalior
Gwalior
MADHYA PRADESH
474002
India |
| Phone |
9827217327 |
| Fax |
|
| Email |
drdilip_kothari@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| patients undergoing short surgical procedures in gajra Raja Medical college, Gwalior. |
|
|
Primary Sponsor
|
| Name |
Dr Seethal Ann Sunny |
| Address |
Department of Anaesthesiology
GR Medical College, Gwalior |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Seethal Ann Sunny |
GR Medical College Gwalior |
Department of Anaesthesiology
GR Medical college
Gwalior
Gwalior
MADHYA PRADESH |
9495280289
seethalannsunny92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe , Gajra Raja Medical College, Gwalior |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N939||Abnormal uterine and vaginal bleeding, unspecified, (2) ICD-10 Condition: K929||Disease of digestive system, unspecified, (3) ICD-10 Condition: N359||Urethral stricture, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine plus Ketamine |
Infusion of intravenous Dexmedetomidine 0.1 mcg/kg in 100 ml normal saline, followed by intravenous ketamine 1 mg/kg. |
| Comparator Agent |
Ketamine and Midazolam |
Infusion of intravenous Midazolam 0.05mg/kg in 100 ml normal saline, followed by intravenous ketamine 1 mg/kg. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Consent to participate in study
ASA physical Grade 1 and 2
Patients undergoing short surgical procedures |
|
| ExclusionCriteria |
| Details |
Patients refusal.
Pregnancy and lactating women.
History of any significant pulmonary, cardiovascular, neurological, hepatoreanal or metabolic disease.
chronic use or addiction to opiates or sedatives. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| we expect that dexmedetomidine plus ketamine will provide adequate depth of anaesthesia and more stable hemodynamic variables. |
20 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| We expect dexmedetomidine plus ketamine to provide less incidence of postoperative complications |
20 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
14/08/2021 |
| 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="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a prospective, double blinded randomised controlled study comparing the effect of intravenous ketamine hydrochloride plus dexmedetomidine hydrochloride and intravenous ketamine hydrochloride plus midazolam hydrochloride in procedural sedation for short surgical procedures. different drug combinations have been used for sedation in short surgical procedures. Here we tried to compare two drug combinations and try to find out a superior combination which would provide adequate sedation, hemodynamic stability and less postoperative complications. |