| CTRI Number |
CTRI/2022/11/047737 [Registered on: 28/11/2022] Trial Registered Prospectively |
| Last Modified On: |
25/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between sedation efficacy of drugs(dexmedetomidine and ketamine)versus (propofol and ketamine) for(ICRT) applicator insertion in cervical cancer patients |
|
Scientific Title of Study
|
Comparison Of Sedative Efficacy Of Dexmedetomidine And Ketamine Vs Propofol And Ketamine For Intra- cavitatory Radiotherapy (ICRT) Applicator Insertion. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SOHINI DATTA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
CHIRAYU MEDICAL COLLEGE AND HOSPITAL |
| Address |
ROOM NO 115 RESIDENT BUILDING FEMALE CHIRAYU MEDICAL COLLEGE AND HOSPITAL BHOPAL
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
9179898227 |
| Fax |
|
| Email |
sohinivenus@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SAURABH TRIVEDI |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
CHIRAYU MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, CHIRAYU MEDICAL COLLEGE AND HOSPITAL, BHOPAL
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
7042461338 |
| Fax |
|
| Email |
drst23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SOHINI DATTA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
CHIRAYU MEDICAL COLLEGE AND HOSPITAL |
| Address |
ROOM NO 115 RESIDENT BUILDING FEMALE CHIRAYU MEDICAL COLLEGE AND HOSPITAL BHOPAL
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
9179898227 |
| Fax |
|
| Email |
sohinivenus@gmail.com |
|
|
Source of Monetary or Material Support
|
| CHIRAYU MEDICAL COLLEGE AND HOSPITAL BHOPAL M.P 462030 |
|
|
Primary Sponsor
|
| Name |
CMCH BHOPAL |
| Address |
CHIRAYU MEDICAL COLLEGE AND HOSPITAL BHOPAL M.P 462030 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| SOHINI DATTA |
CHIRAYU MEDICAL COLLEGE AND HOSPITAL BHOPAL |
3RD FLOOR, DEPARTMENT OF ANAESTHESIOLOGY
Bhopal
MADHYA PRADESH |
9179898227
sohinivenus@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CMCH INSTITUIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C530||Malignant neoplasm of endocervix, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine and ketamine |
2ml(5mcg/cc dexmedetomidine + 2.5 mg/cc ketamine) administered 2-3 times intravascularly,during the period from initiation of procedure till full recovery. |
| Comparator Agent |
Propofol and Ketamine |
2ml(5mg/cc propofol + 5mg/cc ketamine) administered 2-3 times intravascularly during the period from initiation of procedure till full recovery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
All patients belonging to ASA grade 1 and 2 undergoing their first cycle of ICRT applicator insertion at CMCH Bhopal |
|
| ExclusionCriteria |
| Details |
ASA grade 3 and 4
Patients with cardiac diseases(ejection fraction<40%)
Patients with any psychological disorder
Patient with renal disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess the quality of sedation recorded every 5 min and recovery time |
every minute till 3 min follwed by 5 min intervals till recovery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Haemodynamic and respiratory variables
total ketamine consumption
total opiod consumption
incidence of adverse events |
every minute till 3 min follwed by 5 min intervals till recovery for Haemodynamic and respiratory variables
After recovery for total ketamine consumption
total opiod consumption
incidence of adverse events |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
30/11/2022 |
| 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="6"
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
|
The purpose of the study is to compare the effect of Dexmedetomidine and ketamine versus propofol and ketamine on hemodynamic variables, sedation level, recovery period, peri operative adverse events |