| CTRI Number |
CTRI/2025/02/080593 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
26/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the sedative property of two commonly used drugs in surgical patients who are otherwise healthy |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF KETAMINE PROPOFOL AND KETAMINE DEXMEDETOMIDINE FOR IV SEDATION IN SHORT PROCEDURES A RANDOMIZED CONTROL STUDY |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
B.SUNDARI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
TRICHY SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
201,DEPARTMENT OF ANAESTHESIOLOGY, TRICHY SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, IRUNGALUR POST, MANNACHANALLUR TALUK, TIRUCHIRAPALLI
201,DEPARTMENT OF ANAESTHESIOLOGY, TRICHY SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, IRUNGALUR POST, MANNACHANALLUR TALUK, TIRUCHIRAPALLI
Tiruchirappalli
TAMIL NADU
621105
India |
| Phone |
9677596700 |
| Fax |
0431-2258877 |
| Email |
dr.b.sundari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
B.SUNDARI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
TRICHY SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
201,DEPARTMENT OF ANAESTHESIOLOGY, TRICHY SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, IRUNGALUR POST, MANNACHANALLUR TALUK, TIRUCHIRAPALLI
201,DEPARTMENT OF ANAESTHESIOLOGY, TRICHY SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, IRUNGALUR POST, MANNACHANALLUR TALUK, TIRUCHIRAPALLI
Tiruchirappalli
TAMIL NADU
621105
India |
| Phone |
9677596700 |
| Fax |
0431-2258877 |
| Email |
dr.b.sundari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
B.SUNDARI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
TRICHY SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
201,DEPARTMENT OF ANAESTHESIOLOGY, TRICHY SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, IRUNGALUR POST, MANNACHANALLUR TALUK, TIRUCHIRAPALLI
201,DEPARTMENT OF ANAESTHESIOLOGY, TRICHY SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, IRUNGALUR POST, MANNACHANALLUR TALUK, TIRUCHIRAPALLI
Tiruchirappalli
TAMIL NADU
621105
India |
| Phone |
9677596700 |
| Fax |
0431-2258877 |
| Email |
dr.b.sundari@gmail.com |
|
|
Source of Monetary or Material Support
|
| 201,DEPARTMENT OF ANAESTHESIOLOGY, TRICHY SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, IRUNGALUR POST, MANNACHANALLUR TALUK, TIRUCHIRAPALLI , TAMILNADU, INDIA -621105 |
|
|
Primary Sponsor
|
| Name |
Trichy SRM Medical College and Research Centre |
| Address |
201,Department of Anaesthesia, Trichy SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE,Irungalur post, Mannachanallur Taluk, Tiruchirappalli, Tamil Nadu, India- 621105 |
| Type of Sponsor |
Private medical college |
|
|
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 Kirubahar |
Trichy SRM Medical College Hospital and Research Centre |
201, department of anaesthesiology, Trichy SRM medical college, Irungalur post Mannachanallur Taluk
Tiruchirappalli
TAMIL NADU |
9789369474
0431-2258877
rkirubahar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TRICHY SRM IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj.Dexmedetomidine inj.ketamine |
Inj.Dexmedetomidine intravenous administration 0.5microgram/kg single dose
Inj.ketamine 1mg/kg intravenous route single dose |
| Comparator Agent |
Inj.Propofol and inj.ketamine |
Inj.Propofol intravenous administration 1mg/ kg intravenous single dose
Inj.ketamine 1mg/kg intravenous single dose |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
American soceity of anaesthesiologist grade 1&2 patients, weight 40-80kgs, patients undergoing elective short duration daycare surgical procedures |
|
| ExclusionCriteria |
| Details |
Patient refusal,
patients allergic to any drugs,
patients with any uncontrolled systemic illnesses
American soceity of anaesthesiologist grade 3&4
,
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time to first rescue ketamine bolus dose,
total number of rescue boluses,
sedation score,
recovery time after last rescue bolus |
Time of 2nd dose of ketamine after 1st dose of ketamine,
total number of injection ketamine ,
sedation score baseline, 10minutes, 20minutes, 30minutes after propofol or dexmedetomidine injection in both groups,
recovery time and sedation score postoperatively 10minutes, 20minutes, 30minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pulse rate, systolic blood pressure, diastolic blood pressure, oxygen saturation, vomiting, |
Pulse rate , systolic blood pressure, diastolic blood pressure, , oxygen saturation baseline,preinduction, 5,10,20,30,40 minutes intraoperatively,
5,10,20,30 minutes , 2hour postoperatively |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
01/03/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Moderate to deep sedation is a prerequisite for short surgical procedures. It can be achieved by using individual drugs or in combination of drugs. The combination of drugs enhance the desired effect and nullify each other drugs adverse effects. The aim of our study is to compare the safety and efficacy of ketadex( ketamine Dexmedetomidine) intravenously with ketofol ( ketamine propofol) intravenously in short duration procedures with stable hemodynamics and lesser adverse effects. |