| CTRI Number |
CTRI/2026/04/107441 [Registered on: 02/04/2026] Trial Registered Prospectively |
| Last Modified On: |
01/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
COMPARATIVE STUDY OF KETAMINE-PROPOFOL VS KETAMINE-DEXMEDETOMIDINE IN DAYCARE GYNECOLOGICAL PROCEDURES |
|
Scientific Title of Study
|
COMPARING THE EFFECTIVENESS OF KETAMINE-PROPOFOL VERSUS KETAMINE-DEXMEDETOMIDINE COMBINATION IN PATIENTS UNDERGOING HYSTEROSCOPY AND DILATATION AND CURETTAGE PROCEDURES-A RANDOMISED CONTROLLED TRIAL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ABHILASHA TYAGI |
| Designation |
DNB TRAINEE POST MBBS |
| Affiliation |
NORTHERN RAILWAY CENTRAL HOSPITAL,NEW DELHI |
| Address |
Department of Anaesthesia, Northern Railway Central Hospital , Basant Lane , New Delhi , Delhi- 110055
New Delhi
DELHI
110055
India |
| Phone |
7838110825 |
| Fax |
|
| Email |
i.m.abhilashatyagi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MAMTA CHADHA |
| Designation |
ASSISTANT CHIEF HEALTH DIRECTOR AND HEAD OF DEPARTMENT |
| Affiliation |
NORTHERN RAILWAY CENTRAL HOSPITAL,NEW DELHI |
| Address |
EPARTMENT OF ANAESTHESIA , NORTHERN RAILWAY CENTRAL HOSPITAL, BASANT LANE , NEW DELHI
New Delhi
DELHI
110055
India |
| Phone |
09717630526 |
| Fax |
|
| Email |
mamtachadha@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MAMTA CHADHA |
| Designation |
ASSISTANT CHIEF HEALTH DIRECTOR AND HEAD OF DEPARTMENT |
| Affiliation |
NORTHERN RAILWAY CENTRAL HOSPITAL,NEW DELHI |
| Address |
EPARTMENT OF ANAESTHESIA , NORTHERN RAILWAY CENTRAL HOSPITAL, BASANT LANE , NEW DELHI
New Delhi
DELHI
110055
India |
| Phone |
09717630526 |
| Fax |
|
| Email |
mamtachadha@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Northern Railway Central Hospital , Basant Lane,New Delhi 110055 |
|
|
Primary Sponsor
|
| Name |
NORTHERN RAILWAY CENTRAL HOSPITAL |
| Address |
BASANT LANE ,NEW DELHI 110055 |
| 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 |
| Dr Abhilasha Tyagi |
Northern Railway Central Hospital ,New Delhi |
OT Complex, Ward no -5 ,Department of Anaesthesia, Northern Railway Central Hospital, Basant Lane , Delhi -110055
Central
DELHI |
7838110825
i.m.abhilashatyagi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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: O046||Delayed or excessive hemorrhage following (induced) termination of pregnancy, (3) ICD-10 Condition: N921||Excessive and frequent menstruation with irregular cycle, (4) ICD-10 Condition: N924||Excessive bleeding in the premenopausal period, (5) ICD-10 Condition: O02||Other abnormal products of conception, (6) ICD-10 Condition: N950||Postmenopausal bleeding, (7) ICD-10 Condition: O03||Spontaneous abortion, (8) ICD-10 Condition: N949||Unspecified condition associated with female genital organs and menstrual cycle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine and Ketamine combination |
Dexmedetomidine 0.5 mcg per kg followed by Ketamine 50 mg IV with Midazolam 1 mg IV and Paracervical Block using 2% Lignocaine |
| Comparator Agent |
Propofol and Ketamine combination |
Propofol 0.5 mg per kg followed by Ketamine 50 mg IV with Midazolam 1 mg IV and Paracervical Block using 2% Lignocaine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
American Society of Anaesthesiologists Physical status I and II
Aged 18-65 years
Posted for hysteroscopy or dilatation and curettage procedures
Informed consent obtained |
|
| ExclusionCriteria |
| Details |
American society of Anaesthesiologists physical status III and above
Known allergy to test drugs
History of Obstructive sleep apnea
Body Mass Index greater than 35
Baseline Oxygen saturation (SPO2) less than 90%
Bradycardia (Taken as resting heart rate less than 50 beats per minute to account for individual variations and physiological states)
Patient refusal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Determine the difference in Recovery Times ( Time taken to reach Ramsay Sedation Score of 1 after drug administration) in Ketofol(ketamine-propofol) and Dexket(Ketamine-Dexmedetomidine) groups |
Every 5 minutes intra-operatively and every 15 minutes post operatively till 1 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.)To compare the additional Ketamine bolus requirement to maintain RSS(Ramsay Sedation Score) of 4 or BIS 70 in intraoperative period between the two groups
2.
To compare pain in both groups using VAS (visual analog scale) scoring
3.
To compare changes in hemodynamic parameters in the two groups (Mean Arterial Pressure, Heart Rate)
4.
To compare SPO2 changes in the two groups
5.
To compare incidence of Post Operative Nausea Vomiting between the two groups |
Every 5 minutes intra-operatively & every 15 minutes post operatively till 1 hour |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
14/04/2026 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
In this study , we aim to determine the best possible combination for opioid-free monitored anaesthesia care using minimal drugs in patients posted for routine hysteroscopy and dilatation and curettage , to shorten recovery time , minimise pain , reduce incidence of post operative nausea vomiting , maintain stable hemodynamics and oxygen saturation while increasing patient’s comfort and surgeon’s convenience |