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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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

 
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