| CTRI Number |
CTRI/2024/03/063806 [Registered on: 07/03/2024] Trial Registered Prospectively |
| Last Modified On: |
22/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of 2 drug combinations for sedation in cervical cancer patients undergoing radiotherapy |
|
Scientific Title of Study
|
Comparative evaluation of Dexmedetomidine-Ketamine versus Ketamine-Propofol for sedation and
analgesia in cervical cancer patients for intra cavitary brachytherapy: A prospective randomized
double blind 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 |
Dr Sakshi |
| Designation |
Assistant Professor |
| Affiliation |
Ananta institute of medical sciences |
| Address |
Department of anesthesia, OT complex, 2nd floor, Room no.
2041,Ananta institute of medical sciences, Rajsamand
Rajsamand
RAJASTHAN
313202
India
Rajsamand
RAJASTHAN
313202
India |
| Phone |
9571241824 |
| Fax |
|
| Email |
drsakshiarora88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nirdesh Thakore |
| Designation |
Assistant Professor |
| Affiliation |
Ananta institute of medical sciences |
| Address |
Department of anesthesia, OT complex, 2nd floor, Room no.
2041,Ananta institute of medical sciences, Rajsamand
Rajsamand
RAJASTHAN
313202
India
Rajsamand
RAJASTHAN
313202
India |
| Phone |
9461347316 |
| Fax |
|
| Email |
drnirdeshthakore87@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nirdesh Thakore |
| Designation |
Assistant Professor |
| Affiliation |
Ananta institute of medical sciences |
| Address |
Department of anesthesia, OT complex, 2nd floor, Room no.
2041,Ananta institute of medical sciences, Rajsamand
Rajsamand
RAJASTHAN
313202
India
Rajsamand
RAJASTHAN
313202
India |
| Phone |
9461347316 |
| Fax |
|
| Email |
drnirdeshthakore87@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ananta institute of Medical Sciences, Rajasamand RAJASTHAN |
|
|
Primary Sponsor
|
| Name |
Ananta institute of medical sciences |
| Address |
NH8, village Kaliwas, Rajsamand, rajasthan 313202 |
| 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 Nirdesh Thakore |
Ananta institute of medical sciences and research centre |
Ananta institute of Medical Sciences, Department of anesthesia, 2nd floor OT Complex, Room
no. 2041, Rajasamand RAJASTHAN
Rajsamand
RAJASTHAN |
9461347316
drnirdeshthakore87@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Ananta Institute of Medical Science and Research Centre Rajsamand 313202, Rajasthan |
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 |
IV Drug combination (Dexket) |
Dexmedetomidine 0/5mic per kg and ketamine 1 mg per kg IV over 2 minutes. Hemodynamics were followed every 5 min for 30 min and hourly for 6 hours. |
| Comparator Agent |
IV drugs for sedation (Ketofol) |
Ketamine 1mg per kg and Propofol 1 mg per kg IV over 2 minutes. Hemodynamics were followed every 5 min for 30 min and hourly for 6 hours. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Patients of cervical cancer scheduled for elective
brachytherapy
Patients aged between 20-70 years
ASA I, II |
|
| ExclusionCriteria |
| Details |
History of cardiovascular diseases e.g. ischaemic heart disease,conduction defects, etc.
History of compromised renal / hepatic / neuronal functions.
Uncontrolled hypertension and Diabetes
Pregnant or lactating women.
History alcohol, substance abuse, chronic use of analgesic and
sedatives, psychiatric disorders
Patients on b blocker or having persistent bradycardia with HR30
min |
|
|
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 |
| Onset and recovery of sedation |
Baseline, 1,2,5,7,10,15,20,25 and 30 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intraoperative Haemodynamics (Heart
Rate,Blood Pressure, Spo2, Respiratory rate)
Post op recovery score (Modified Aldrete Score)
Duration of analgesia |
Baseline, 1, 2,5,7,10,15,20,25 & 30 minutes & then hourly for 6 hours. |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
15/03/2024 |
| 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
|
Patients will be allocated to one of the following two groups as per randomization:.Group DK( 23): inj dexmedetomidine (0.5 mic/kg) and ketamine (1 mg/kg) and Group KP ( 23) : inj ketamine 1mg/kg and propofol 1 mg/kg diluted to total volume of 10 ml will be given before beginning the procedure over the period of 2 minutes. Time is recorded to achieve RSS score of 6 that will indicate onset of sedation. Patients are then placed inlithotomy position and procedure is started which consists of dilation of cervical canal and insertion of applicators and adequate vaginal packing. After completion of procedure patient is again made supine and time is recorded till patients achieve RSS 3, and then shifted to post op area and followed for 6 hours post operatively |