| CTRI Number |
CTRI/2025/06/089426 [Registered on: 24/06/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
To compare effect of Dexmedetomidine and Remitentanil in patients posted for Endoscopic Retrograde cholangiography (ERCP) |
|
Scientific Title of Study
|
A comparative study of effect of Dexmedetomidine and Remifentanil infusion for patients undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP). A Double blind randomized clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deep Trambadiya |
| Designation |
Post Graduate student |
| Affiliation |
Institute of medical science and sum hospital |
| Address |
Department of Anesthesiology,IMS and SUM hospital,Siksha O Anusandham University,Bhubaneswar,Khorda
Khordha
ORISSA
751003
India |
| Phone |
9537492082 |
| Fax |
|
| Email |
deep21patel96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Swastika Swaro |
| Designation |
Professor |
| Affiliation |
Institute of medical science and sum hospital |
| Address |
Department of Anesthesiology,IMS and SUM hospital,Siksha O Anusandham University,Bhubaneswar,Khorda
Khordha
ORISSA
751003
India |
| Phone |
9861628628 |
| Fax |
|
| Email |
drswastika81@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deep Trambadiya |
| Designation |
Post Graduate student |
| Affiliation |
Institute of medical science and sum hospital |
| Address |
Department of Anesthesiology,IMS and SUM hospital,Siksha O Anusandham University,Bhubaneswar,Khorda
Khordha
ORISSA
751003
India |
| Phone |
9537492082 |
| Fax |
|
| Email |
deep21patel96@gmail.com |
|
|
Source of Monetary or Material Support
|
| IMS and SUM Hospital,Siksha O Anusandhan University, Bhubaneswar,Khorda |
|
|
Primary Sponsor
|
| Name |
Institute of medical science and sum hospital |
| Address |
Department of Anesthesiology,IMS and SUM hospital,Siksha O Anusandham University,Bhubaneswar,Khorda. Khordha ORISSA 751003 India |
| Type of Sponsor |
Private 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 Deep Trambadiya |
Institute of medical sciences , Siksha o Anusadhan |
Department of Anesthesiology,IMS and SUM hospital,Siksha O Anusandham University,Bhubaneswar,Khordha
Khordha
ORISSA |
9537492082
deep21patel96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee,IMS and SUM Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine |
Inj.Dexmedetomidine 1 mcg/kg intravenously for 10 minutes followed by infusion of 0.2-0.7 mcg/kg/hour during the surgery. |
| Intervention |
Remifentanil |
Inj.Remifentanil 1 mcg/kg intravenously bolus for 1 minute followed by infusion of 0.15-0.5 mcg/kg/hour during the surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients age between 18 to 60 undergoing for ERCP
2) ASA physical status I-II |
|
| ExclusionCriteria |
| Details |
1) Neurological disease
2) Psychiatric disease
3) Cardiovascular disease (Arrhythmia, Heart failure, coronary artery disease)
4) Anticipated difficult airway
5) Pulmonary disease (asthma, COPD)
6) Pregnant patients
7) Known allergy to study drugs |
|
|
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 estimate the dose of Propofol during procedure |
Duration of Surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate
Haemodynamic stability (MAP, Heart Rate) |
Duration of Surgery |
| Incidence of Respiratory depression (SpO2 less than less 90% or Respiratory rate less than 8 per minute) |
Duration of Surgery |
| Ramsay sedation score |
At the end of procedure and at 1 hour post operative period |
| Incidence of side effect (Nausea, Vomiting and Delirium) |
Post operative period for 1 hour |
|
|
Target Sample Size
|
Total Sample Size="118"
Sample Size from India="118"
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 4 |
|
Date of First Enrollment (India)
|
10/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/07/2025 |
| 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 is a Double blinded randomised clinical trial conducted at our institution in ERCP operation theatre
•The data to be collected are all part of routine care. •
All the Data collected will be entered in Microsoft excel 2007 and further analysed in SPSS VERSION-27.
In this study 118 patients between age 18 years to 60 years posted for ERCP procedure are included
With reference from previous study (Propofol-Dexmedetomidine versus Propofol-Ketamine for Anaesthesia of Endoscopic Retrograde Cholangiopancreatography (ERCP) (Comparative Study), The Egyptian Journal of Hospital Medicine (April 2023) Vol.91) Significance= 0.05 Power= 0.8 Allowable difference= 40 Standard deviation(SD)= 70 Margin= 0 Drop rate(%)= 10 After drop rate sample size: 108 Corrected estimate total sample size: 118, with the help of Cleveland clinic sample size calculator.
After taking written informed consent from patients , patients will be randomized to 2 groups (n= 108 each ) by computer generated random number table. All patients will be thoroughly examined pre-operatively which includes blood pressure, heart rate, respiratory rate and systemic examination, and ASA grading. The patients with a contraindication to procedure like allergic reaction to any drugs, major neurological, cardiovascular, psychology, respiratory abnormalities will be excluded
Physiological parameters such as Heart Rate, Respiratory rate, Oxygen saturation and non invasive blood pressure will be monitored continuously, at the beginning of the procedure, on the first, fifth minute and every 5 minutes until the transfer of the patient to the post anaesthetic care unit. Level of sedation will be assessed using Ramsay sedation score at the end of the Procedure and 1 hour after the procedure in the post anaesthetic care unit. Patients will be observed for occurrence of any side effects like nausea, vomiting, delirium in the post anaesthetic care unit.
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