| CTRI Number |
CTRI/2025/11/096809 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Which sedation method helps patients recover faster after egg retrieval for IVF? |
|
Scientific Title of Study
|
Comparative study on the effects of two different techniques of combining dexmedetomidine and ketamine on post operative recovery time in patients undergoing oocyte retrieval: a randomised controlled pilot 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 |
Aditi Singh |
| Designation |
Post Graduate resident |
| Affiliation |
Armed Forces Medical College, Pune |
| Address |
Department of Anaesthesiology ,Southern Command , Solapur Pune Hwy near race course ,Wanowrie, Pune , Maharashtra 411040 Department of Anaesthesiology ,Southern Command , Solapur Pune Hwy near race course ,Wanowrie, Pune , Maharashtra 411040 Pune MAHARASHTRA 411001 India |
| Phone |
8890115992 |
| Fax |
|
| Email |
singhdraditi@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Jyoti Joshi |
| Designation |
Professor |
| Affiliation |
Armed Forces Medical College, Pune |
| Address |
Military hospital, range hill road, range hills, Pune, Maharashtra Southern Command, Solapur Pune Hwy near race course, Wanowrie, Pune, Maharashtra 411040 Pune MAHARASHTRA 411020 India |
| Phone |
9644838766 |
| Fax |
|
| Email |
jjoshi00@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Jimna Joy |
| Designation |
Assistant Professor |
| Affiliation |
Armed Forces Medical College |
| Address |
Southern Command, Solapur Pune Hwy near race course, Wanowrie, Pune ,Maharashtra Southern Command,Solapur Pune Hwy near race course, Wanowrie, Pune, Maharashtra 411040 Pune MAHARASHTRA 411040 India |
| Phone |
7896472979 |
| Fax |
|
| Email |
jimnajoy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Armed Forces Medical College , Southern Command , Solapur Pune Hwy near race course ,Wanowrie, Pune , Maharashtra 411040 |
|
|
Primary Sponsor
|
| Name |
Aditi Singh |
| Address |
Department of Anesthesiology,Southern Command , Solapur Pune Hwy, near race course , Wanowrie, Pune , Maharashtra ,India 411040 |
| Type of Sponsor |
Other [Self] |
|
|
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 Jimna Joy |
Command Hospital , Southern Command |
Department of Anaesthesiology ,Southern Command , Solapur Pune Hwy , near race course, Wanowrie, Pune, Maharashtra Pune MAHARASHTRA |
7896472979
jimnajoy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECAFMCPUNE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N970||Female infertility associated withanovulation, (2) ICD-10 Condition: N979||Female infertility, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
In Group A, patients will receive a maintenance dose of 0.7 mcg/kg/hr dexmedetomidine, titrated to maintain sedation |
In Group A, patients will receive an induction dose of 1 mcg/kg dexmedetomidine administered over 10 minutes and induction dose of 0.25 mg/kg Ketamine. This will be followed by a maintenance dose of 0.7 mcg/kg/hr dexmedetomidine, titrated to maintain sedation throughout the procedure. The infusion will be discontinued immediately upon completion of the procedure. |
| Comparator Agent |
In Group B, patients will receive a continuous infusion of 70 mcg/kg/min ketamine, combined with 0.2 mcg/kg/hr dexmedetomidine , titrated to maintain sedation |
In Group B, patients will receive an induction dose of 1 mg/kg ketamine. The maintenance phase will involve a continuous infusion of 70 mcg/kg/min ketamine, combined with 0.2 mcg/kg/hr dexmedetomidine, ensuring a stable level of sedation throughout the procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Women undergoing elective oocyte retrieval.
ASA I & II patients.
Age between 18 years to 40 years.
Patients willing to provide informed consent.
|
|
| ExclusionCriteria |
| Details |
Patients who deny consent will not be included in the study.
ASA III and ASA IV.
Past history of allergy to dexmedetomidine and ketamine.
Chronic sedative and opioid use |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the post operative recovery time measured from procedure end to Modified Aldrete score more than equal to 9 at 10mis, 20 mins and 30 mins |
To compare the post operative recovery time measured from procedure end to Modified Aldrete score more than equal to 9 at 10 mins,20 mins and 30 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate & compare hemodynamic stability in terms of heart rate & blood pressure at various time intervals intraoperatively.
To assess pain score (VAS Score) on complete recovery, at thirty minutes & at sixty minutes from the end of the procedure.
To evaluate the need for rescue analgesia.
To investigate the adverse effects like nausea, vomiting, dizziness, hallucinations during recovery time.
|
complete recovery, at 30 minutes & at 60 minutes from the end of the procedure |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
12/11/2025 |
| 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="1" Months="3" Days="1" |
|
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 vitro fertilization is a common treatment for infertility. Ultrasound guided transvaginal follicle aspiration is the standard method for oocyte retrieval and is the most painful part of the IVF process. Adequate anesthesia is needed to reduce pain and ensure patient comfort. Total intravenous anesthesia has been shown to improve quality of recovery after short ambulatory procedures. The ideal anesthetic technique should provide good pain control, quick recovery, minimal side effects, and should not affect oocyte quality. Dexmedetomidine is an alpha 2 receptor agonist that provides sedation, analgesia, and anxiety relief without depressing respiration. It improves patient satisfaction and reduces the need for opioids but may cause bradycardia, hypotension, and limited deep sedation. Ketamine, an NMDA receptor antagonist, produces strong analgesia and preserves airway reflexes and cardiovascular stability. However, its use alone may lead to hallucinations and agitation. Combining dexmedetomidine with ketamine can balance their effects, offering effective sedation and analgesia while minimizing adverse reactions. This study is designed as a prospective randomized controlled trial to compare postoperative recovery time in patients receiving a combination of dexmedetomidine and ketamine using two different techniques during oocyte retrieval. The objective is to identify the safer and more effective method that provides optimal sedation, stable hemodynamics, minimal side effects, and faster postoperative recovery, thereby improving patient comfort and satisfaction in IVF procedures |