| 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
|
|
|
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
|
|
|
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. |