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CTRI Number  CTRI/2025/06/088012 [Registered on: 02/06/2025] Trial Registered Prospectively
Last Modified On: 22/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   The efficacy of keto-dex medicine as compared to keto-lig medicine for pain management of patients undergoing keyhole surgery for surgery scar site hernia. 
Scientific Title of Study   Comparison of analgesic efficacy of keto-dex versus keto-lig as opioid sparing maintenance analgesics in patient undergoing laparoscopic incisional hernia under entropy guided general anaesthesia: 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  Sudhansu Sekhar Nayak 
Designation  Assistant Professor 
Affiliation  All India Institute Of Medical Sciences , New Delhi 
Address  Room no- 5011,Department of Anesthesiology, Pain medicine and Critical care, Academic building, All India Institute Of Medical Sciences , New Delhi
Ansari Nagar, South Delhi
New Delhi
DELHI
110029
India 
Phone  8874756836  
Fax    
Email  nayak.sudhansusekhar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sudhansu Sekhar Nayak 
Designation  Assistant Professor 
Affiliation  All India Institute Of Medical Sciences , New Delhi 
Address  Room no- 5011,Department of Anesthesiology, Pain medicine and Critical care, Academic building, All India Institute Of Medical Sciences , New Delhi
Ansari Nagar, South Delhi
New Delhi
DELHI
110029
India 
Phone  8874756836  
Fax    
Email  nayak.sudhansusekhar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sudhansu Sekhar Nayak 
Designation  Assistant Professor 
Affiliation  All India Institute Of Medical Sciences , New Delhi 
Address  Room no- 5011,Department of Anesthesiology, Pain medicine and Critical care, Academic building, All India Institute Of Medical Sciences , New Delhi
Ansari Nagar, South Delhi
New Delhi
DELHI
110029
India 
Phone  8874756836  
Fax    
Email  nayak.sudhansusekhar@gmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Medical Sciences ,New Delhi 
 
Primary Sponsor  
Name  All India Institute Of Medical Sciences 
Address  Ansari Nagar, New Delhi, Delhi, PIN- 110029 
Type of Sponsor  Research institution and hospital 
 
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 
Sudhansu Sekhar Nayak  All India Institute Of Medical Sciences, New Delhi   Operation Theatre no.- 2,3,4,5,6,10,11,12. Surgical Block. Department of Anesthesiology, pain medicine and critical care.
South
DELHI 
8874756836

nayak.sudhansusekhar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE ALL INDIA INSTITUTE OF MEDICAL SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group 2(keto-lig) ketamine and lignocaine infusion   After induction of anesthesia, for group 2 (ketamine:0.2mg per kg per hour and lignocaine: 1mg per kg per hour) infusion will be started for maintenance analgesia. Infusion of both drugs will be administered via two separate infusion pumps simultaneously and will be continued till port removal. Extra doses of fentanyl(0.5mcg/kg) bolus will be given to every patient under entropy guided monitoring and if the difference between response entropy (RE) and state entropy (SE) exceed more than 10 and will be noted. 
Comparator Agent  Group 3 (Control): Normal Saline infusion   After induction of anesthesia, for control group 3, normal saline infusion will be started for maintenance analgesia and will be continued till port removal. Extra doses of fentanyl(0.5mcg/kg) bolus will be given to every patient under entropy guided monitoring and if the difference between response entropy (RE) and state entropy (SE) exceed more than 10 and will be noted. 
Intervention  Group1(keto-dex) ketamine and dexmedetomidine infusion  After induction of anesthesia, for group 1 (ketamine:0.2mg per kg per hour and dexmedetomidine: 0.5µg per kg per hour) infusion will be started for maintenance analgesia. Infusion of both drugs will be administered via two separate infusion pumps simultaneously and will be continued till port removal. Extra doses of fentanyl(0.5mcg/kg) bolus will be given to every patient under entropy guided monitoring and if the difference between response entropy (RE) and state entropy (SE) exceed more than 10 and will be noted. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Age 18 years to 60 years
2.American Society of Anaesthesiologists (ASA) physical status 1 and 2
3.Undergoing elective laparoscopic incisional hernia under general anesthesia
 
 
ExclusionCriteria 
Details  1.Presence of any uncontrolled cardiovascular disease (hypertension, conduction block etc)
2.Presence of any cerebrovascular or neurological disease (seizure, past history of stroke etc)
3.Patient on any anti-psychotic drugs or antidepressant drugs
4.Patient on beta blocker
5.Presence of any chronic liver or kidney disease
6.Pregnant and nursing women
7.Surgery duration more than 3 hours
8.BMI more than 35 KG/M2
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare intraoperative fentanyl consumption between two groups  15 minutes,30 minutes,45 minutes,60 minutes,90 minutes,120 minutes, 150 minutes post intubation  
 
Secondary Outcome  
Outcome  TimePoints 
Intra- operative haemodynamic   5 minute, 10 minute, 15 minute, 30 minute ,45 minute, 60 minute, 90 minute,120 minute 150 minute 
Post operative analgesia requirements  15 min, 30 min, 1 hour,2hours,4hours,8hours,12hours 
Post operative sedation score  15 min, 30 min, 1 hour,2hours,4hours,8hours,12hours 
Recovery time   postoperative period  
Post operative nausea & vomiting   Numeber of episodes in postoperative period 
 
Target Sample Size   Total Sample Size="135"
Sample Size from India="135" 
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/ Phase 3 
Date of First Enrollment (India)   07/06/2026 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  
Opioid have been the main stay to provide analgesia for surgeries. These are however associated with numerous side effects varying from simple delayed recovery to precarious complication like respiratory depression, post operative nausea  vomiting. Opioid sparing maintenance analgesia (OSMA) which include non opioid analgesics has now emerged as a feasible and safe alternative to the conventional opioid based general anaesthesia. The drug most commonly used for non opioid analgesics are dexmedetomidine, ketamine, lignocaine ,MgSO4,dexamethasone and paracetamol. Previous studies have proved that this non opioid analgesics are equally efficacious to opioid and can be alternative to opioids. In previous studies, those used either single drug infusion or combination drug (for example., ketamine and dexmedetomidine)  showed they are equally efficacious to fentanyl and can be used as an alternative to opioid. But there is no study comparing the combination of non opioid analgesics. So we thought to conduct a study comparing the combination of non opioid analgesics under entropy guided monitoring. We will divide all the recruited patient into three groups keto-dex, keto-lig and control groups. For keto-dex group(ketamine:0.2mg/kg/hours+ dexmedetomidine :0.5 microgram/kg/hour) and for keto-lig group (ketamine:0.2mg/kg/hour + lignocaine: 1 mg/kg/hour) and for control group normal saline infusion will be started immediately after  intubation for maintenance analgesia in intraoperative period with entropy monitoring. Extra doses of fentanyl (0.5mcg/kg) bolus will be given to every patients under entropy guided monitoring and if the difference between response entropy(RE )and state entropy(SE) exceed more than 10 and will be noted in every patients in all group.   In the postoperative period rescue analgesia will be done by fentanyl and noted. In the postoperative period assessment of pain will be done by VAS, recovery by modified Aldrete’s score, sedation by Ramsay sedation score.
 
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