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CTRI Number  CTRI/2023/03/050603 [Registered on: 13/03/2023] Trial Registered Prospectively
Last Modified On: 13/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study to compare Midazolam vs. Fentanyl for sedation during Diagnostic bronchoscopy.  
Scientific Title of Study   A Prospective, Randomized, Double Blind Study to compare safety and comfort of Midazolam vs. Fentanyl administration during Diagnostic flexibile bronchoscopy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mohanakrishnan Deivasigamani 
Designation  Postgraduate Resident 
Affiliation  ACS Medical College and Hospital 
Address  Department of Respiratory Medicine, ACS Medical College and Hospital, Poonamalle High Road Velappanchavadi Chennai 600 077 Tamil Nadu, India

Chennai
TAMIL NADU
600077
India 
Phone  9884037716  
Fax    
Email  mohankrisdeiv@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Chockalingam Chandrasekar 
Designation  Professor and Head of the Department 
Affiliation  ACS Medical College and Hospital 
Address  Department of Respiratory Medicine, ACS Medical College and Hospital, Poonamalle High Road Velappanchavadi Chennai 600 077 Tamil Nadu, India

Chennai
TAMIL NADU
600077
India 
Phone  9941198101  
Fax    
Email  drcc.ghtm@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mohanakrishnan Deivasigamani 
Designation  Postgraduate Resident 
Affiliation  ACS Medical College and Hospital 
Address  Department of Respiratory Medicine ACS Medical College and Hospital Poonamalle High Road Velappanchavadi Chennai 600 077 Tamil Nadu, India

Chennai
TAMIL NADU
600077
India 
Phone  9884037716  
Fax    
Email  mohankrisdeiv@gmail.com  
 
Source of Monetary or Material Support  
ACS Medical College and Hospital Poonamalle High Road Velappanchavadi Chennai 600 077 Tamil Nadu, India 
 
Primary Sponsor  
Name  ACS Medical College and Hospital 
Address  Poonamalle High Road Velappanchavadi Chennai 600 077 Tamil Nadu, India 
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 
Mohanakrishnan Deivasigamani  ACS Medical College and Hospital  Bronchoscopy Suite,Department of Respiratory Medicine,ACS Medical college and Hospital,Poonamalle High Road Velappanchavadi Chennai 600 077 Tamil Nadu, India
Chennai
TAMIL NADU 		 9884037716

mohankrisdeiv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee, ACS Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J00-J99||Diseases of the respiratory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intravenous Fentanyl  Intravenous Fentanyl - 0.5 mcg/Kg/dose given at start of bronchoscopy. 
Comparator Agent  Intravenous Midazolam  Intravenous Midazolam - 0.035 mg/kg/dose given at start of bronchoscopy.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients in the age group of 18–70 years who were advised flexible bronchoscopy for diagnostic workup 
 
ExclusionCriteria 
Details  1.Severe cardiac & Respiratory impairment
2.Bleeding diathesis
3.Not willing for procedure
4.Depression of consciousness or cognitive impairment rendering them unable to answer the questionnaires
5.History of hypersensitivity or contraindications to the drugs used in the study.

 
 
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 
1.Haemodynamic and respiratory parameters.

2.Ramsay sedation score(RSS) during the procedure.

3.Composite score of bronchoscopist reported comfort level during the procedure.

4.Composite score of patient‑reported tolerance and satisfaction with the procedure. 		 1.Baseline , every 10 minutes till the end of procedure,10 minutes post procedure

2.10 minutes after intravenous sedation.

3.Questionarie for the bronchoscopist will be administered after procedure

4.Questionarie for the patient will be administered after 6 hours of procedure.  
 
Secondary Outcome  
Outcome  TimePoints 
1.Comparision of Rescue doses across two groups.
2.Lignocaine dose used. 		 During the procedure 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/03/2023 
Date of Study Completion (India) 13/11/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

AIM & OBJECTIVES

 1.To study and compare the safety and comfort of midazolam and fentanyl during flexible bronchoscopy under sedation.

 2.Questionarie of the patient and bronchoscopist will be analysed. 

MATERIALS AND METHODS

STUDY SITE: ACS MEDICAL COLLEGE AND HOSPITALS, DEPARTMENT OF RESPIRATORY MEDICINE.

STUDY DESIGN: RANDOMIZED CONTROL TRIAL – DOUBLE BLINDED, TWO ARM, EQUIVALENCE TRIAL.

PROCEDURE:  

1.Before beginning the procedure, the vital parameters such as pulse rate, blood pressure, respiratory rate, and SpO2 levels will be noted, and continuous monitoring initiated.

2.Participants under study shall undergo computer-generated block randomization with variable block sizes. The respective randomization lists shall be kept in sealed, opaque envelopes for allocation concealment.

3. A member of the bronchoscopy team not involved in the study shall prepare the study drug after picking randomization slip and inject the study drugs away from the vision of the investigators (who shall be blinded to the sedation given).

4.For participants randomized to Arm 1- midazolam 1-2 mg IV (0.035 mg/kg) and for participants randomized to Arm 2 - fentanyl 25- 50 mcg IV (0.5 mcg/Kg) will be given.

5.Two ml of 2% lignocaine jelly will be administered into one of the patent nostrils of the patient.

6.After an additional waiting period of 2 min, the bronchoscope is passed through the patent nostril and then the throat. Two ml of 2% lignocaine spray will be sprayed at the throat and additional 2 ml at vocal cords, by spray as you go technique.

7.The bronchoscope is advanced below the vocal cords and stationed at the level of carina, where 1 ml 2% lignocaine is sprayed.

8.If the Ramsay Sedation Scale (RSS) was 1 at any time after the lignocaine application was completed, the rescue medication in the form of Injection Midazolam 0.5 mg IV  will be administered in a stepwise manner, with a 2 min gap between doses.

7.The bronchoscope is advanced beyond carina where 1 ml of 2% lignocaine is sprayed into each main bronchus, the bronchoscope was advanced into either bronchus to evaluate the bronchial tree, and the sampling procedure for which the patient was scheduled is completed.

8.Vital parameters such as pulse rate, blood pressure, respiratory rate, and SpO2 levels will be recorded at 5 min interval from time zero – i.e., from insertion of bronchoscope.

9.Lidocaine dosage, completeness of the procedure, complications if any, and total duration of procedure will be noted.

10.Vital parameters will be recorded 10 min after completion of the procedure.

11.Six hours after completion of flexible bronchoscopy, a questionnaire – adapted from an earlier study – provided to the patients. This assess patient’s tolerance of the procedure and their satisfaction level.

12. Primary and secondary outcomes will be assed.

Ethical guidelines for biomedical research on human subjects (as perICMR) will be followed.Subjects will be enrolled only after obtaining informed consent and assent. Privacy & confidentiality ofsubjects will be maintained.

 



 
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