| CTRI Number |
CTRI/2023/03/050236 [Registered on: 02/03/2023] Trial Registered Prospectively |
| Last Modified On: |
24/02/2023 |
| 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 two drugs for anaesthesia during dilation and curettage in females with abnormal menstrual bleeding |
|
Scientific Title of Study
|
Comparative evaluation of Dexmedetomidine-Ketamine versus Ketamine-Propofol for sedation and analgesia in patients undergoing Dilation and Curettage: A prospective randomized double blind study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankita Kaasat |
| Designation |
Assistant Professor Anaesthesia |
| Affiliation |
Ananta institute of medical sciences |
| Address |
Room no. 2041, second floor, OT complex, Ananta institute of medical science, Rajsamand 313202, rajasthan
NH-8, Village Kaliwas, distt rajsamand 313202, Rajasthan
Rajsamand
RAJASTHAN
313202
India |
| Phone |
6361854732 |
| Fax |
|
| Email |
ankitakaasat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ankita Kaasat |
| Designation |
Assistant Professor Anaesthesia |
| Affiliation |
Ananta institute of medical sciences |
| Address |
Room no. 2041, second floor, OT complex, Ananta institute of medical science, Rajsamand 313202, rajasthan
NH-8, Village Kaliwas, distt rajsamand 313202, Rajasthan
RAJASTHAN
313202
India |
| Phone |
6361854732 |
| Fax |
|
| Email |
ankitakaasat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ankita Kaasat |
| Designation |
Assistant Professor Anaesthesia |
| Affiliation |
Ananta institute of medical sciences |
| Address |
Room no. 2041, second floor, OT complex, Ananta institute of medical science, Rajsamand 313202, rajasthan
NH-8, Village Kaliwas, distt rajsamand 313202, Rajasthan
RAJASTHAN
313202
India |
| Phone |
6361854732 |
| Fax |
|
| Email |
ankitakaasat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ananta Institute of medical sciences. NH8, Village kaliwas,district rajsamand, 313202, rajasthan |
|
|
Primary Sponsor
|
| Name |
Ananta institute of medical sciences |
| Address |
NH-8, Village Kaliwas, Dist Rajsamand 313202, Rajasthan |
| 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 |
| Ankita Kaasat |
ANANTA INSTITUTE OF MEDICAL SCIENCES |
NH-8, Village Kaliwas, Dist Rajsamand
Rajsamand
RAJASTHAN |
6361854732
ankitakaasat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N925||Other specified irregular menstruation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
inj ketamine and propofol |
inj propofol 1 mg/kg and ketamine 1 mg/kg given IV over 2 min |
| Comparator Agent |
inj. Ketamine and Dexmedetomidine |
inj. Ketamine 1 mg/kg and Dexmedetomidine 0.5 mcg/kg given IV slow over 2 min |
| Intervention |
inj propofol and ketamine |
inj propofol 1 mg/kg and ketamine 1 mg/kg given IV over 2 min |
| Intervention |
inj. Ketamine and Dexmedetomidine |
Ketamine 1 mg/kg and Dexmedetomidine 0.5 mcg/kg combined in single syringe given IV slow over 2 min |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Patients of abnormal uterine bleeding scheduled for elective endometrial sampling
American Society of Anaesthesiology I and II
|
|
| ExclusionCriteria |
| Details |
History of cardiovascular diseases e.g. ischemic heart disease, conduction defects, etc.
History of compromised renal / hepatic / neuronal functions.
Uncontrolled Hypertension and Diabetes
History of alcohol, substance abuse, chronic use of analgesic and sedatives, psychiatric disorders
•Patients on beta blocker or having persistent bradycardia with HR<60.
•Drug allergy
•Procedure lasting for >30 min.
•Any surgical complications during D& C e.g. uterine perforation, excessive bleeding etc.
•Viable Pregnancy, acute PID, undiagnosed genital tract bleeding, mass in vagina or cervix, severe arthritis hip bone, bleeding disorders, virgin females
|
|
|
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 |
| Time to onset of sedation (Ramsay sedation score RSS 6) and recovery from sedation (RSS 3) |
Time to onset of sedation (Ramsay sedation score RSS 6) and recovery from sedation (RSS 3) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Intraoperative Haemodynamics (Heart Rate, Blood Pressure, Spo2, Respiratory rate)
2.Post op recovery score ( Modified Aldrete Score)
3.Duration of analgesia
|
0min, 10, 20, 30 min |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
13/03/2023 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Informed consent will
be taken from each patient willing to participate in the study. They will be allocated to one of the following two groups
as per randomization. Group
DK(n=40): will receive inj dexmedetomidine (0.5 mic/kg)
and ketamine (1 mg/kg) and Group
KP (n=40) : will receive inj ketamine 1mg/kg and propofol
1 mg/kg diluted to total volume of 10 ml 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 in
lithotomy position and procedure is started. 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. RSS and
hemodynamic parameters, Spo2 and RR are monitored every 5 min. If sedation
score is <6 then inj. Ketamine 0.5mg/kg is given as rescue drug for sedation
and analgesia.
In post op area patients are shifted to ward as per
Alderete criteria >9.
Duration of analgesia will be recorded for both groups
and inj diclofenac 75 mg will be used as rescue analgesia if VAS>3. |