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CTRI Number  CTRI/2025/09/094890 [Registered on: 16/09/2025] Trial Registered Prospectively
Last Modified On: 15/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study comparing the effects of ketamine and dexmedetomidine with paracetamol on pain relief after laparoscopic gynecological cancer surgery. 
Scientific Title of Study   Comparative study between preemptive Ketamine and Dexmedetomidine with intravenous Paracetamol for post-operative analgesia in laparoscopic gynecological cancer surgeries: A Double-blinded randomized 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  Shubham Kumar 
Designation  Junior Resident, Department of Anaestheisology 
Affiliation  Indira Gandhi Institute of Medical Sciences, Patna 
Address  Indira Gandhi Institute of Medical Sciences, Patna Department of Anaesthesiology

Patna
BIHAR
800014
India 
Phone  8299632128  
Fax    
Email  Shubhamkumar2324@yahoo.in  
 
Details of Contact Person
Scientific Query  
Name  Puja Kumari 
Designation  Associate Professor, Department of Anaestheisology 
Affiliation  Indira Gandhi Institute of Medical Sciences, Patna 
Address  Indira Gandhi Institute of Medical Sciences, Patna Department of Anaesthesiology

Patna
BIHAR
800014
India 
Phone  8758272237  
Fax    
Email  drpujachoudhary16@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shubham Kumar 
Designation  Junior Resident, Department of Anaestheisology 
Affiliation  Indira Gandhi Institute of Medical Sciences, Patna 
Address  Indira Gandhi Institute of Medical Sciences, Patna Department of Anaesthesiology


BIHAR
800014
India 
Phone  8299632128  
Fax    
Email  Shubhamkumar2324@yahoo.in  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Shubham Kumar 
Address  Indira Gandhi Institute of Medical Sciences, Patna Department of Anaesthesia Pin 800014  
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 Shubham Kumar  Indira Gandhi Institute of Medical Sciences, Patna  Department of Anaesthesiology, 13 ward block, 1st floor IGIMS
Patna
BIHAR 		 08299632128

Shubhamkumar2324@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, IGIMS, Patna- 14  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C55||Malignant neoplasm of uterus, partunspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dexmedetomidine with IV Paracetamol  Dexmedetomidine at a dose of 0.5 mcg/kg, diluted in 10mL of NS and administered intravenously over 10minutes and intravenous Paracetamol 1gm(100ml) is infused, 20min before incision 
Intervention  Ketamine with IV Paracetamol  Ketamine at a dose of 0.5 mg/kg, diluted in 10 mL of NS and administered Intravenously over 10 minutes and intravenous Paracetamol 1gm(100ml) is infused, 20min before incision. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  Female age 18-80 years.
Patients of ASA physical status 1,2 & 3.
Female Undergoing elective laparoscopic gynecological cancer surgeries. 
 
ExclusionCriteria 
Details  Patient’s refusal to participate.
Patients of psychiatric disorders and unable to understand VAS and substance abuse.
Drug allergy.
Pregnant females.
History of any underlying cardiac, hepatic, renal dysfunction. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy and safety of pre-emptive ketamine with Intravenous Paracetamol vs pre-emptive dexmedetomidine with Intravenous paracetamol for postoperative analgesia in patients undergoing laparoscopic gynaecological cancer surgeries.  Immediately after extubating, 0hr, 15min, 30min, 45min, 60min, 2hour, 4hour, 8hour,12 hour, 24hour 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the hemodynamic stability between two groups.

2. To compare time to first rescue analgesic need & total opioids consumption in 24hour after surgery.

3. To observe the incidence of side effects & complication. 		 Immediately after extubating, 0hr, 15min, 30min, 45min, 60min, 2hour, 4hour, 8hour,12 hour, 24hour 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   01/10/2025 
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="6"
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   This is a prospective, randomized, double-blind controlled trial designed to compare the efficacy and safety of preemptive intravenous ketamine with paracetamol versus intravenous dexmedetomedine with paracetamol for post- operative analgesia in female patients undergoing elective laparoscopic gynaecological cancer surgeries. The study will asses postoperative pain scores, total  analgesia consumption and adverse effects associated with each intervention. 
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