| CTRI Number |
CTRI/2025/11/098180 [Registered on: 28/11/2025] Trial Registered Prospectively |
| Last Modified On: |
27/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Dexmedetomidine vs Ketamine infusion performance characteristics of CLADS |
|
Scientific Title of Study
|
Effect of Dexmedetomidine vs Ketamine infusion on the performance of propofol based closed loop anaesthesia delivery system for controlling depth of sedation in patients undergoing endoscopic retrograde cholangiopancreatography: a parallel arm randomised controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Varun Mahajan |
| Designation |
Assistant professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
4th floor, Nehru Hospital, Sector 12,
Department of Anaesthesia and Intensive Care,
PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9988882149 |
| Fax |
|
| Email |
v.varunm88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suma A Tilavalli |
| Designation |
Junior resident |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
4th floor, Nehru Hospital, Sector 12,
Department of Anaesthesia and Intensive Care,
PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9988882149 |
| Fax |
|
| Email |
sumatilavalli74@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Varun Mahajan |
| Designation |
Assistant professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research |
| Address |
4th floor, Nehru Hospital, Sector 12,
Department of Anaesthesia and Intensive Care,
PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9988882149 |
| Fax |
|
| Email |
v.varunm88@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute of Medical Education and Research |
| Address |
Sector 12
Chandigarh, 160012 |
| 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 |
| Varun Mahajan |
PGIMER, Chandigah |
Endoscopy suite, Department of Hepatology, Level 3, Nehru hospital extension
Chandigarh
CHANDIGARH |
9988882149
v.varunm88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, PGIMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CLADS dexmedetomidine group |
Injection fentanyl 1 mics/kg, dexmed 0.7 mics/kg loading will be given, following which CLADS based propofol infusion will be started to maintain BIS 60 and MOAAS of less than 2. |
| Intervention |
CLADS-ketamine group |
Injection ketamine will be administered at a dose of 0.5 mg/kg after inj fentanyl administration at a dose of 1 µg/kg. Following this induction will be started using propofol based CLADS to target a BIS of 60. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age more than equal to 18
Procedural duration more than 20 min |
|
| ExclusionCriteria |
| Details |
Patients failing to achieve MOAAS less than 2 when BIS of 60 is achieved
Age more than 80
BMI more than 35
History of snoring or OSA
Allergy to any study drug
Hemodynamic instability requiring vasopressors
LVEF less than 25 percent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the percentage of valid CLADS time Bispectral Index (BIS) values remain within the target range 60 ± 10 during sedation maintained by Closed Loop Anaesthesia Delivery System for propofol when supplemented with dexmedetomidine versus ketamine. |
During the ERCP procedural sedation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Percentage of the valid CLADS time for which BIS remains in the range of 60 ± 5. |
During the ERCP procedural sedation |
| Performance error |
During the ERCP procedural sedation |
| Median performance error |
During the ERCP procedural sedation |
| Median absolute performance error |
During ERCP procedural sedation |
| Global score |
During the ERCP procedural sedation |
| Wobble |
During the ERCP procedural sedation |
| Hemodynamic stability – any fall or increase in blood pressure or heart rate ± 25% of the baseline parameters |
During the ERCP procedural sedation |
| Duration for which heart rate or blood pressure remains ± 25% of the baseline |
During the ERCP procedural sedation |
| Episodes of apnea requiring intervention to maintain the airway |
During the ERCP procedural sedation |
| Total propofol used (mg and mg/kg) |
During the ERCP procedural sedation |
| Plasma target concentration of propofol (Marsh model) required to achieve BIS 60 |
During the ERCP procedural sedation |
| Plasma concentration of propofol required to achieve a BIS of 60 |
During the ERCP procedural sedation |
| Total dexmedetomidine used (µg and µg/kg) |
During the ERCP procedural sedation |
| Total ketamine used in mg and mg/kg |
During the ERCP procedural sedation |
| Time to awakening in minutes |
During the ERCP procedural sedation |
| Patient discomfort during the procedure |
During the ERCP procedural sedation |
| Need to give additional intravenous bolus of the study drugs |
During the ERCP procedural sedation |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/12/2025 |
| 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 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
|
This study will assess the anaesthetic depth control using CLADS based on propofol sedation using two interventions. First is the combination of propofol-CLADS with dexmedetomidine infusion and the second is the combination with ketamine infusion. The target BIS for propofol-CLADS will be 60 ± 10. |