| CTRI Number |
CTRI/2025/10/095681 [Registered on: 07/10/2025] Trial Registered Prospectively |
| Last Modified On: |
06/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to Find Out Whether Low-Dose Dexmedetomidine Works Better Than Fentanyl in Preventing Confusion and Restlessness When Adults Wake Up After General Anaesthesia. |
|
Scientific Title of Study
|
Low dose Dexmedetomidine versus Fentanyl for Attenuation of Emergence Delirium after General Anaesthesia in Adults: 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 |
Taba Annu |
| Designation |
Junior Resident |
| Affiliation |
Regional Institute of Medical Sciences Imphal Manipur |
| Address |
LH 2, Department of Anaesthesiology, Regional Institute of Medical Sciences Imphalwest Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
9205678194 |
| Fax |
|
| Email |
naneannutaba@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
L Pradipkumar Singh |
| Designation |
Professor |
| Affiliation |
Regional Institute of Medical Sciences Imphal Manipur |
| Address |
Department of Anaesthesiology, Regional Insitute of Medical Sciences Imphalwest Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
7005238251 |
| Fax |
|
| Email |
drlaithangba@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
L Pradipkumar Singh |
| Designation |
Professor |
| Affiliation |
Regional Institute of Medical Sciences Imphal Manipur |
| Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences Imphalwest Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
7005238251 |
| Fax |
|
| Email |
drlaithangba@gmail.com |
|
|
Source of Monetary or Material Support
|
| Regional Institute of Medical Sciences Imphalwest Manipur India 795004 |
|
|
Primary Sponsor
|
| Name |
Taba Annu |
| Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences Imphalwest Manipur India 795004 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Taba Annu |
Regional Institute of Medical Sciences Imphal |
Modular OT complex, Ground floor, Room Number 1, Department of anaesthesia Regional institute of medical sciences imhalwest manipur India
Imphal West
MANIPUR |
09205678194
naneannutaba@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH ETHICS BOARD RIMS |
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 |
Dexmedetomidine |
Patients will be given Fentanyl 1mcg/kg Intravenous bolus plus Dexmedetomidine 0.2mcg/kg/hr intravenous infusion just after induction of anaesthesia till closure of incision. |
| Comparator Agent |
Fentanyl |
Patients will receive a Fentanyl 1mcg/kg Intravenous bolus plus a Fentanyl 1mcg/kg/hr intravenous infusion just after the induction of anaesthesia and will be given till the closure of incision. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex
18- 60 years of age
American Society of Anaesthesiologists physical status I or II
Elective surgery under general anaesthesia
Pre-operative MMSE (Mini-Mental state Examination) score more than or equal to 24
BMI less than or equal to 30 kg per m2
|
|
| ExclusionCriteria |
| Details |
Patient’s refusal to sign a written informed consent.
Severe neurological or psychiatric disorders.
Patients on Tranquilizer or antidepressant medication.
Patients with history of smoking or alcohol consumption during the last 48 hours.
Patients with chronic lung disease.
Oto-laryngological procedures (Which poses additional challenges for emergence
agitation).
Haemodynamically unstable patients.
Anticipated difficult airway (Multiple attempts of endotracheal intubation increases
emergence delirium).
|
|
|
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 mean emergence delirium score in the two study groups |
Post extubation 20 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to first rescue analgesia |
1st hour |
| Extubation time |
End of surgery |
| Postoperative nausea & vomiting (PONV) |
1st hour |
| Emergence time |
1st hour |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
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)
|
17/11/2025 |
| 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="2"
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 study, Low dose Dexmedetomidine versus Fentanyl for attenuation of Emergence Delirium after general anaesthesia in adults: a randomised controlled trial will be undertaken in the Department of Anaesthesiology, RIMS, Imphal, from August 2025 to July 2027. After obtaining institutional ethics committee approval and written informed consents from the patients, 94 patients will be randomized into two groups. Group A patients will be started on Inj. Fentanyl 1mcg per kg IV bolus plus Inj. Dexmedetomidine 0.2 mcg per kg per hr IV infusion. Group B patients will receive a Fentanyl 1 mcg per kg IV bolus plus a Fentanyl 1 mcg per kg per hr infusion following induction of anaesthesia with propofol and maintenance with 50 percent Nitrous oxide in oxygen with Sevoflurane 0.6 to 1.5 percent to titrate the BIS value to 40 – 60 and ETCO2 30-35 mmHg. Infusion drugs will be stopped 15-20 minutes before the end of skin closure and inhalational agents will be cut-off 5-10 minutes before end of skin closure. Reversal of residual neuromuscular blockade will be done when the end tidal anaesthetic agent concentration is less than MAC-Awake. Data will be collected and tabulated in excel format for analysis using SPSS. Data will be analysed using appropriate statistics and a p-value of less than 0.05 will be considered significant |