| CTRI Number |
CTRI/2025/08/092608 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two different pain reducing regimens/drugs to reduce pain in patients undergoing abdominal surgery |
|
Scientific Title of Study
|
Intraoperative Dexmedetomidine Versus Ketamine-Dexmedetomidine Infusion For Postoperative Analgesia In Major Abdominal Surgery: A 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 |
Dr Shreem Rawal |
| Designation |
Senior Resident |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Dept. of Anaesthesiology, Institute of Liver and Biliary Sciences
D1 Vasant Kunj, Ghitorni
New Delhi
DELHI
110070
India |
| Phone |
8827058005 |
| Fax |
|
| Email |
shreem.rawal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Udit Dhingra |
| Designation |
Associate Professor |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Dept. of Anaesthesiology,
3rd floor phase 2
Institute of Liver and Biliary Sciences
D1 Vasant Kunj, Ghitorni
New Delhi
DELHI
110070
India |
| Phone |
8861987684 |
| Fax |
|
| Email |
uddh1989@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Udit Dhingra |
| Designation |
Associate Professor |
| Affiliation |
Institute of Liver and Biliary Sciences |
| Address |
Dept. of Anaesthesiology, 3rd floor phase 2
Institute of Liver and Biliary Sciences
D1 Vasant Kunj, Ghitorni
New Delhi
DELHI
110070
India |
| Phone |
8861987684 |
| Fax |
|
| Email |
uddh1989@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Liver and Biliary Sciences D1 Vasant Kunj , Ghitorni, New Delhi , India 110070 |
|
|
Primary Sponsor
|
| Name |
ILBS |
| Address |
D1 Vasant Kunj, New Delhi
110070 |
| 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 |
| Dr Shreem Rawal |
Institute of Liver and Biliary Sciences |
Dept. of Anaesthesiology,
3rd floor phase 2
Institute of Liver and Biliary Sciences D1 Vasant Kunj new Delhi 110070
South
DELHI |
8827058005
shreem.rawal@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Drug:Dexmedetomidine |
Route: Intravenous
Dose: 0.5mcg/kg/hr |
| Intervention |
Drug:Dexmedetomidine with Ketamine |
Route: Intravenous
Dose: 0.3mcg/kg/hr and 0.3mg/kg/hr respectively |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA class 1 & 2 |
|
| ExclusionCriteria |
| Details |
Patient refusal
Contraindication to study drugs
History of drug abuse
Insufficient comprehension to use of PCA
ASA class 3 & 4
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the postoperative fentanyl consumption for the first 24 hours using IV PCA in following two groups of patients undergoing major abdominal surgery
Group A – Intraoperative IV dexmedetomidine infusion
Group B – Intraoperative IV ketodex infusion
|
Post Operative 24hr
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the intraoperative anesthetic requirements |
End of Surgery |
| To compare the intraoperative fentanyl requirements |
End of surgery |
| To compare the postoperative pain scores using NRS |
0,2,4,12,24hrs |
| To compare the time of first rescue analgesia requirement |
Post Operative |
| To record incidence of post operative nausea and vomiting |
Post Operative |
| To record incidence of post operative delirium using CAM ICU score |
post operative |
| - To compare the postoperative sedation score using the Modified Ramsay Sedation Scale(MRSS) |
postoperative |
| To compare the intraoperatively hemodynamic parameters |
15mins |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
25/08/2025 |
| 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="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
|
Effective amelioration of pain following major abdominal surgery remains a fundamental challenge. Acute postoperative pain after abdominal surgery can be a significant problem because it has been shown to alter the metabolic response, delayed recovery with a longer stay and increased morbidity, as well as the development of a chronic pain The intrinsic antinociceptive and anti-hyperalgesia properties of dexmedetomidine reportedly reduces postoperative opioid consumption. Perioperative ketamine has a consistent opioid-sparing effect, minimizes the development of tolerance, and reduces the postoperative pain scores Several pharmacological options exist for adequate perioperative pain management. However, each drug has its pros and cons limiting its broad applicability. Opioids remain the cornerstone of perioperative analgesia but they produce numerous side effects, including respiratory depression,postoperative hyperalgesia, nausea, vomiting, ileus, and urinary retention To the best of our knowledge, no study has assessed the postoperative analgesia produced by the simultaneous use of ketamine and dexmedetomidine (ketodex infusion) as intraoperative anesthetic adjuvants. Multimodal approach to perioperative analgesia is recommended in clinical guidelines and is essential to Enhanced Recovery After Surgery (ERAS) clinical practice |