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CTRI Number  CTRI/2025/04/084901 [Registered on: 16/04/2025] Trial Registered Prospectively
Last Modified On: 09/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To know the effectiveness of low dose ketamine in postoperative period in patients who are undergoing cesarean section under spinal anesthesia  
Scientific Title of Study   A randomized control study to evaluate the effect of low dose intravenous ketamine on postoperative pain following cesarean section under spinal anesthesia at SMS medical college Jaipur 
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 Trishala Jain  
Designation  Senior Professor  
Affiliation  SMS Medical College and Hospital Jaipur 
Address  Department of Anesthesiology 2nd floor dhanwantari building sms medical college Jaipur Rajasthan

Jaipur
RAJASTHAN
302004
India 
Phone  9414281744  
Fax    
Email  trishala.jain31@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Trishala Jain  
Designation  Senior Professor  
Affiliation  SMS Medical College Jaipur and Hospital Jaipur 
Address  Department of Anesthesiology 2nd floor dhanwantari building sms medical College Jaipur Rajasthan

Jaipur
RAJASTHAN
302004
India 
Phone  9414281744  
Fax    
Email  trishala.jain31@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Neelam Jorwal  
Designation  Junior Resident  
Affiliation  SMS Medical College Jaipur and Hospital Jaipur 
Address  Department of Anesthesiology 2nd floor dhanwantari building sms medical college Jaipur Rajasthan

Jaipur
RAJASTHAN
302004
India 
Phone  9968418159  
Fax    
Email  neelamjorwal70@gmail.com   
 
Source of Monetary or Material Support  
Department of Anesthesiology SMS Medical College and Attached Hospitals Jaipur Rajasthan 302004 
 
Primary Sponsor  
Name  SMS Medical College and Attached Hospitals Jaipur 
Address  Department of Anesthesiology 2nd floor dhanwantari building sms medical college Jaipur Rajasthan 302004 
Type of Sponsor  Government medical college 
 
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 Neelam Jorwal   SMS Medical College and Attached Hospitals   Department of Anesthesiology 2nd floor dhanwantari building sms medical college Jaipur Rajasthan 302001
Jaipur
RAJASTHAN 		 9968418159

neelamjorwal70@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of Ethics Committee, SMS Medical College and Attached Hospitals Jaipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ketamine   After spinal anaesthestia intravenous ketamine is given in dose of 250mcg per kilogram once before skin incision Surgery is started after desired level of anesthesia is achieved and intraoperative hemodynamic are monitored and maintained Examine Patient at 0hr 1hr 2hr 6hr 12hr and 24hr for numeric rating scale ,blood pressure, pulse,and saturation  
Intervention  Normal saline   10 ml normal saline injected intravenous once after spinal anaesthestia before skin incision Surgery started after desired level of anesthesia achieved and intraoperative vitals are monitored and maintained Examine patient at 0hr 1hr 2hr 6hr 12hr and 24hr for numeric rating scale, blood pressure, pulse and saturation  
Comparator Agent  Numeric rating scale Time to first analgesia request Total analgesia consumption Hemodynamic parameter   Examining patient at 0hr 1 hr 2 hr 6hr 12hrand 24 hr for numeric rating score, blood pressure, pulse and saturation Patients given training and instructed to self report pain using wlevn point numeric Rating scale At time from spinal anesthesia given to first time patient request for analgesia is noted Total dose of painkiller given in mg within the first 24hr post surgery  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Elective patients undergoing cesarean section, willing to give informed and written consent, single term pregnancy 
 
ExclusionCriteria 
Details  parturients taking part in other study,non cooperative parturients, BMI more than 30 kilogram per meter square, parturients with Known to ketamine,high blood pressure ,hight intracranial, history of seizure, parturients who took pre or intraoperative analgesic  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess and compare postoperative numerical rating scale between the two groups
To assess and compare the time of first rescue analgesia between the groups
To assess and compare total dose of 24 hours analgesia between the two groups  		 Just and after 1 2 6 12 and 24 hours of completion of surgery  
 
Secondary Outcome  
Outcome  TimePoints 
To assess and compare hemodynamic variables that are blood ,heart rate peripheral capillary oxygen saturation   Just and after every 15 minutes of spinal anesthesia till completion of surgery
Just and after 1 2 6 12 and 24 hours of completion of surgery  
 
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)   23/05/2025 
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="0"
Months="3"
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   A randomized case control  study to evaluate  the effect of low dose intravenous ketamine on postoperative pain following cesarean section under spinal anaesthestia in department of anesthesia . 
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