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CTRI Number  CTRI/2024/10/074581 [Registered on: 01/10/2024] Trial Registered Prospectively
Last Modified On: 30/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study to compare the effect of lignocaine and ketamine in reducing the analgesic requirement in the first 24 hours 
Scientific Title of Study   Comparative study of the effect of lignocaine and ketamine as intra-operative and post-operative analgesics in elective surgeries under general anaestgesia- A randomized control 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  Buvanesh 
Designation  Post graduate 
Affiliation  Sri Venkateshwaraa medical college Hospital and Research center  
Address  Department of Anaesthesialogy and critical care. Sri Venkateshwaraa medical college Hospital and Research center No. 13-A, pondy-villupuram main road, Ariyur,Pondicherry

Pondicherry
PONDICHERRY
605102
India 
Phone  9944797370  
Fax    
Email  buvaneshsundar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrJayashridevi 
Designation  Professor  
Affiliation  Sri Venkateshwaraa medical college Hospital and Research center  
Address  Department of Anaesthesialogy and critical care. Sri Venkateshwaraa medical college Hospital and Research center No. 13-A, pondy-villupuram main road, Ariyur,Pondicherry

Pondicherry
PONDICHERRY
605102
India 
Phone  8754689690  
Fax    
Email  Dr.jayashridevi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Buvanesh 
Designation  Post graduate 
Affiliation  Sri Venkateshwaraa medical college Hospital and Research center  
Address  Department of Anaesthesialogy and critical care. Sri Venkateshwaraa medical college Hospital and Research center No. 13-A, pondy-villupuram main road, Ariyur,Pondicherry

Pondicherry
PONDICHERRY
605102
India 
Phone  9944797370  
Fax    
Email  buvaneshsundar@gmail.com  
 
Source of Monetary or Material Support  
Sri Venkateshwaraa medical college Hospital and Research center, no. 13-A,pondy-villupuram main road, Ariyur,Pondicherry,India, 605102 
 
Primary Sponsor  
Name  Dr Buvanesh 
Address  Sri Venkateshwaraa medical college Hospital and Research center, no. 13-A,pondy-villupuram main road, Ariyur,Pondicherry,India, 605102 
Type of Sponsor  Other [Self (principal investigator)] 
 
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 Buvanesh  Sri Venkateshwaraa medical college, hospital and research centre  No.1, OT complex, Department of anesthesia, pondy-villupuram main road ,ariyur,puducherry
Pondicherry
PONDICHERRY 		 9944797370

buvaneshsundar@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ketamine and lignocaine  Group A: 1.5 mg/kg IV bolus of lignocaine before induction, followed by a 3 hour continuous infusion of 1.5 mg/kg/hr 
Intervention  ketamine and lignocaine  Group B: 0.5 mg/kg of IV ketamine administered during induction by continuous infusion of 0.5 mg/kg/h for 3 hours and perioperative analgesics requirement is compared. 
Comparator Agent  not applicable  not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients aged between 18 and 60 belonging to either sex undergoing elective surgery under General
anaesthesia.
2. American Society of Anaesthesiologist 1 and 2 
 
ExclusionCriteria 
Details  1. Patients requiring postoperative mechanical ventilation
2. Pregnancy or Breastfeeding
3. Body mass index (≥35 kg/m2)
4. Allergy to study drug
5. Contraindications to use of study medications such as cardiac, renal, hepatic disease,
seizure or other neurological disorder,
6. Chronic substance abuse
7. History of chronic pain 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effects of Ketamine and Lignocaine in reducing the analgesic
requirements in peri-operatively for first 24 hours.
 		 0,15mins,30mins,45mins,60mins,75mins,90mins,105mins,120mins. 
 
Secondary Outcome  
Outcome  TimePoints 
1. VAS scores in post-operative patients.
2. Time of initial rescue analgesia.
3. Total number of analgesics used within the first 24 hours.
4. To observe nausea, vomiting, and shivering post-operatively.
5. To assess intraoperative and postoperative hemodynamic changes.
 		 0,15mins,30mins,45mins,60mins,2hrs,4hrs,6hrs,8hrs,10hrs,12hrs,14hrs,16hrs,18hrs,20hrs,22hrs,24hrs. 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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 2 
Date of First Enrollment (India)   17/10/2024 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [buvaneshsundar@gmail.com].

  6. For how long will this data be available start date provided 03-09-2024 and end date provided 03-03-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The thesis investigates the effectiveness of lignocaine versus ketamine as analgesics during and after elective surgeries conducted under general anesthesia. Through a randomized control trial, the study aims to compare these two medications in terms of their efficacy in managing pain during the operation and in the postoperative period. The objective is to determine which of the two drugs offers better pain relief, potentially leading to improved patient outcomes and reduced reliance on opioids. 
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