| CTRI Number |
CTRI/2025/03/083757 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
In this study, we will compare the effect of two doses of dexmedetomidine, an analgesic and sedative on recovery of gastrointestinal function in postoperative period. |
|
Scientific Title of Study
|
Comparison of effect of two different doses of intraoperative Dexmedetomidine infusion on recovery of gastrointestinal movement in adult patients undergoing emergency abdominal surgery : A randomised clinical 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 |
NITIN KUMAR |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF TRAUMA & EMERGENCY (ANAESTHESIOLOGY) IGIMS CAMPUS SHEIKHPURA PATNA
Patna
BIHAR
800014
India |
| Phone |
8076070302 |
| Fax |
|
| Email |
kumarnitin516@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NITIN KUMAR |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF TRAUMA & EMERGENCY (ANAESTHESIOLOGY) IGIMS CAMPUS SHEIKHPURA PATNA
Patna
BIHAR
800014
India |
| Phone |
8076070302 |
| Fax |
|
| Email |
kumarnitin516@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NITIN KUMAR |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF TRAUMA & EMERGENCY (ANAESTHESIOLOGY) IGIMS CAMPUS SHEIKHPURA PATNA
Patna
BIHAR
800014
India |
| Phone |
8076070302 |
| Fax |
|
| Email |
kumarnitin516@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Institute of Medical Sciences |
| Address |
IGIMS CAMPUS SHEIKHPURA PATNA 800014 |
| Type of Sponsor |
Government medical college |
|
|
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 NITIN KUMAR |
EMERGENCY OPERATION THEATER |
EMERGENCY BLOCK,INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES, IGIMS CAMPUS, SHEIKHPURA
Patna
BIHAR |
8076070302
kumarnitin516@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,IGIMS, PATNA |
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 |
General Anaesthesia |
After arrival in the operating room, routine monitoring devices will be attached. All patients will be premedicated with intravenous glycopyrrolate 0.2mg followed by standardised general anaesthesia consisting of intravenous induction using propofol 2mg/kg, atracurium 0.5mg/kg and fentanyl 2µg/kg. Endotracheal intubation will be performed in all subjects. Following intubation, group A will receive a loading dose of dexmedetomidine hydrochloride as 1µg/kg followed by a maintainance dose 0.5µg/kg/hr while group B will receive a loading dose of 0.5µg/kg followed by a maintainance dose of 0.2µg/kg/hr. Anaesthesia will be maintained with atracurium and a mixture of oxygen, air and isoflurane. |
| Comparator Agent |
Normal dose of dexmedetomidine vs low dose of dexmedetomidine |
Group A - loading dose of 1 µg/kg over 15 minutes followed by maintainance dose of 0.5 µg/kg/hr
Group B - loading dose of 0.5 µg/kg over 15 minutes followed by maintainance dose of 0.2 µg/kg/hr |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Body weight 50 - 70 kg
Patient undergoing emergency abdominal surgeries |
|
| ExclusionCriteria |
| Details |
Patient refusal
Preoperative use of opioids
Bradycardia
Heart block greater than first degree
Preoperative use of antihypertensive drugs containing clonidine or an a2-agonist
Difficulty in communication
Abnormal liver or renal function
Bowel disease (Ulcerative Colitis, Crohns disease and IBS) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| time to first flatus in postoperative periods |
any time during the postoperative period corrected to the nearest hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| postoperative gastrointestinal function measured by I-FEED scoring system |
measure over first 72 hr of postoperative period |
| time to first feces |
any time during the postoperative period corrected to nearest hour |
| time to first oral feeding |
any time during the postoperative period corrected to nearest hour |
| incidence of delirium |
measure twice daily for first 3 days during the postoperative period |
| pain score |
measure for 7 postoperative days |
| sleep quality |
measure for 7 postoperative days |
| postoperative nausea & vomiting |
measure for 7 postoperative days |
| hospital costs |
total amount of money that will spend during hospital stay |
| hospital length of stay |
total number of days patient will spend in hospital |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/05/2025 |
| 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="0"
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 randomised clinical trials aims to compare the effects of two different intraoperative dexmedetomidine infusion doses on postoperative gastrointestinal recovery in adults patients undergoing emergency abdominal surgery. The study will evaluate the impact of a normal dose (loading 1 µg/kg over15 minutes followed by 0.5 µg/kg/h maintenance) versus a low dose (loading 0.5 µg/kg over 15 minutes followed by 0.2 µg/kg/h maintenance).
The primary outcome is the time ti first flatus postoperatively, serving as a key indicator for gastrointestinal recovery. Secondary outcomes include I-FEED score assesment, time to first feces, time to first oral feeding, incidence of delirium, pain scores, sleep quality, postoperative nausea and vomiting, hospital costs and length of hospital stay.
This study aims to provide evidence regarding the optimal dexmedetomidine dosing strategy to enhance gastrointestinal recovery, reduce postoperative complications and improve overall patient outcomes following emergency abdominal surgery. Findings may contribute to improved perioperative management protocols and enhanced recovery strategies in surgical patients. |