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CTRI Number  CTRI/2025/07/091216 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 19/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of Ketamine-Dexmedetomidine (KETODEX) and Ketamine-Propofol (KETOFOL) for sedation during flexible bronchoscopy 
Scientific Title of Study   The Effectiveness of comparision of Ketamine and Dexmedetomidine (KETODEX) infusion versus Ketamine and Propofol(KETOFOL) infusion for sedation during flexible bronchoscopy. 
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 Birva Khara 
Designation  Professor 
Affiliation  Pramukhswami Medical college, Bhaikaka University 
Address  Department of Anaesthesiology, Pramukhswami Medical college, Shree Krishna Hospital, Karamsad Anand. GUJARAT 388325

Anand
GUJARAT
388325
India 
Phone  9537122077  
Fax    
Email  Birvank@charutarhealth.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Birva Khara 
Designation  Professor 
Affiliation  Pramukhswami Medical college, Bhaikaka University 
Address  Department of Anaesthesiology, Pramukhswami Medical college, Shree Krishna Hospital, Karamsad Anand. GUJARAT 388325


GUJARAT
388325
India 
Phone  9537122077  
Fax    
Email  Birvank@charutarhealth.org  
 
Details of Contact Person
Public Query  
Name  Dr Pruthil Patel 
Designation  Resident Doctor - Department of Anaesthesiology 
Affiliation  Pramukhswami Medical college, Bhaikaka University 
Address  112,Department of Anaesthesiology,HM patel center for medical care and education,karamsad-388325,Anand GUJARAT,India 388325

Anand
GUJARAT
388325
India 
Phone  8200393464  
Fax    
Email  pruthil2019patel@gmail.com  
 
Source of Monetary or Material Support  
Shree Krishna Hospital, Anand 388325 
 
Primary Sponsor  
Name  Shree Krishna Hospital 
Address  Karamsad, Anand, Gujarat 388325 
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 Birva Khara  Pramukhswami medical college  112,Department of Anaesthesiology,HM patel center for medical care and education,karamsad-388325,Anand GUJARAT,India 388325
Anand
GUJARAT 		 9537122077

Birvank@charutarhealth.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMTTEE-2 Bhaikaka University,Karamsad,Anand,Gujrat-388325  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J989||Respiratory disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  KETODEX (IV infusion of Ketamine 4 mg/ml + Dexmedetomidine 4 mcg/ml)  KETODEX (Intervention Group) Type of Product: Investigational combination of approved drugs Name of Product: KETODEX Dosage Form: Intravenous infusion Composition: Ketamine 4 mg/ml Dexmedetomidine 4 mcg/ml Dosage Regimen: Loading dose: 0.25–0.5 ml/kg, initiated 15–20 minutes prior to procedure in recovery room with monitoring Maintenance dose: 0.025–0.25 ml/kg/hr Additional bolus: 0.0125–0.25 ml/kg as required to achieve Ramsay Sedation Score (RSS) 4 Route of Administration: Intravenous Frequency: Continuous infusion during procedure Indication: Procedural sedation during flexible bronchoscopy 
Comparator Agent  KETOFOL (IV infusion of Ketamine 5 mg/ml + Propofol 5 mg/ml)  KETOFOL Type of Product: Investigational combination of approved drugs Name of Product: KETOFOL Dosage Form: Intravenous infusion Composition: Ketamine 5 mg/ml Propofol 5 mg/ml Dosage Regimen: Loading dose: 0.075–0.1 ml/kg over 30 seconds Maintenance dose: 0.075–0.1 ml/kg/hr Additional bolus: 0.025 ml/kg as required to achieve Ramsay Sedation Score (RSS) 4 Route of Administration: Intravenous Frequency: Continuous infusion during procedure Indication: Procedural sedation during flexible bronchoscopy 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  ASA 1 ,2,3
Spontaneously breathing patients scheduled for flexible bronchoscopy under sedation 
 
ExclusionCriteria 
Details  Allergy to ketamine, propofol, or dexmedetomidine

Tracheostomized or intubated patients

Patients with heart block or recent myocardial infarction

Patients who convert to mechanical ventilation 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effectiveness of Ketamine and Dexmedetomidine (Ketodex) vs. Ketamine and Propofol (Ketofol) for sedation during flexible bronchoscopy.  post procedure for 1 hour 
 
Secondary Outcome  
Outcome  TimePoints 
To assess patient satisfaction, bronchoscopy satisfaction, coughing response of patient, assess the need for other drugs, assess the intraprocedure and post procedure complications   Post procedure 1 hour 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   31/07/2025 
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 study aims to evaluate the effectiveness and safety of two sedative drug combinations—KETODEX and KETOFOL—for sedation in patients undergoing flexible bronchoscopy. Both regimens are used in clinical practice; however, comparative evidence is limited. The primary outcome will be achieving adequate sedation defined by a Ramsay Sedation Score (RSS) >4. Secondary outcomes include patient and bronchoscopist satisfaction, incidence of complications, and requirement for rescue drugs. This randomized, double-blind study will be conducted at a single center in Gujarat, India.

 
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