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CTRI Number  CTRI/2025/07/091023 [Registered on: 16/07/2025] Trial Registered Prospectively
Last Modified On: 08/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Observation of the sedation practices in the crtically ill patients and development of sedation protocol based on intial obseravtion and expert recommendations  
Scientific Title of Study   Development of a Sedation Protocol for Mechanically Ventilated Patients: A Mixed-Methods 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  Dr Sagar M S 
Designation  Additional Professor  
Affiliation  Kasturba Medical College, Manipal Academy of Higher Education 
Address  Dept of critical care, Kasturba Medial College Manipal

Udupi
KARNATAKA
576104
India 
Phone  9764391100  
Fax    
Email  sagar.ms@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sagar M S 
Designation  Additional Professor  
Affiliation  Kasturba Medical College, Manipal Academy of Higher Education 
Address  Dept of critical care, Kasturba Medial College Manipal

Udupi
KARNATAKA
576104
India 
Phone  9764391100  
Fax    
Email  sagar.ms@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Sagar M S 
Designation  Additional Professor  
Affiliation  Kasturba Medical College, Manipal Academy of Higher Education 
Address  Dept of critical care, Kasturba Medial College Manipal

Udupi
KARNATAKA
576104
India 
Phone  9764391100  
Fax    
Email  sagar.ms@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College and hospital, Manipal, Madhav Nagar, Manipal, Karnataka , Pin 576104 
 
Primary Sponsor  
Name  Kasturba Medical College, MAHE,Manipal, Karnataka 
Address  Kasturba Medical College, MAHE, Manipal, 576104, Udupi District, Karnataka 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sagar M S  Kasturba hospital and Kasturba Medical College , Manipal, Karnatak  Department of critical care, Intensive care unit number 1 and 2, first floor, new trauma block
Udupi
KARNATAKA 
09764391100

sagar.ms@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Implementation of a standardized, validated sedation protocol  This pilot trial evaluates a non-drug interventional sedation protocol using approved sedatives; hence the trial phase is marked as Not Applicable. The intervention involves implementing a standardized sedation protocol for adult ICU patients on mechanical ventilation. This protocol includes the use of sedation assessment tools such as the Richmond Agitation-Sedation Scale (RASS) and Sedation-Agitation Scale (SAS), protocol-based titration of commonly used sedatives (Midazolam, Propofol, Dexmedetomidine, and Fentanyl), and non-pharmacologic measures such as daily sedation interruption, nurse-led assessments, and individualized sedation targets. The goal of the intervention is to optimize sedation depth, enhance patient comfort, minimize sedation-related complications, and support timely ventilator weaning. 
Comparator Agent  Traditional Sedation practices  In this single-arm pilot interventional study. The outcomes will be compared to baseline practices and historical data collected prior to protocol implementation.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patient more than 18 year requiring mechanical ventilation 
 
ExclusionCriteria 
Details  patient with traumatics brain injury, stroke, neurodegenrative disorders 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Feasiblity and adherence to sedation protocol  30 days follow up 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of delirium, ICU length of stay,Mortality rate and Feedback from staff  30 days follow up 
 
Target Sample Size   Total Sample Size="237"
Sample Size from India="237" 
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)   01/08/2025 
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="3"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
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 prospective study will be conducted in three phases following ethical approval and informed consent from patients or their legal guardians. Phase 1 is a quantitative observational study to document current sedation practices in ICU patients, including types and doses of sedatives, frequency and methods of sedation assessment, target sedation levels, and inter-provider variability. Phase 2 includes two components. Phase 2a is a qualitative study using semi-structured interviews and focus group discussions to explore barriers and facilitators to sedation protocol adherence among ICU staff. Phase 2b involves the development of a structured sedation protocol using the modified Delphi method with input from a multidisciplinary expert panel. The protocol will undergo content validation by clinicians, nurses, and psychologists to ensure clarity, relevance, and feasibility. Phase 3 is a single-arm feasibility study to implement the validated sedation protocol in the ICU. The protocol includes RASS-based sedation targets, 4-hourly RASS assessments, twice-daily CAM-ICU delirium checks, standardized sedative titration, daily sedation interruption when appropriate, and a sedation checklist during rounds. ICU staff will receive prior training. Outcomes assessed will include protocol adherence, usability, safety, and staff feedback. Adverse events monitored will include hypotension, bradycardia, respiratory depression, over- or under-sedation, agitation, delirium, and drug-specific complications. Criteria for withdrawal include serious adverse effects or protocol non-compliance. Data collection will include baseline demographic and clinical data, serial RASS assessments every 4 to 6 hours, CAM-ICU assessments twice daily, and follow-up until ICU discharge, including a 7-day post-discharge phone follow-up for delayed adverse effects. The study may be terminated early if significant safety concerns arise. This pilot trial evaluates a non-drug interventional sedation protocol using approved sedatives; hence the trial phase is marked as Not Applicable. This phased approach aims to develop and validate a practical, safe, and effective sedation protocol for ICU patients on mechanical ventilation.

 
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