FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/10/074972 [Registered on: 09/10/2024] Trial Registered Prospectively
Last Modified On: 26/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two sedative drugs (dexmeditomidine and remifentanil) with respect to vital signs and recovery time in patients who undergo a camera test of the windpipe (rigid bronchoscopy). 
Scientific Title of Study   A Comparison between Dexmedetomidine and Remifentanil for rigid Bronchoscopic Pulmonary Procedures A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Muralidhara P 
Designation  DM-Senior Resident 
Affiliation  All India Institute Of Medical Sciences- New Delhi 
Address  Dr BR Ambedkar Institute rotary cancer hospital, AIIMS Campus, Ansari Nagar East, New Delhi

New Delhi
DELHI
110029
India 
Phone  8553134764  
Fax    
Email  mdr1205@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Brajesh kumar Ratre 
Designation  Associate Professor 
Affiliation  All India Institute Of Medical Sciences- New Delhi 
Address  Dr BR Ambedkar Institute rotary cancer hospital, AIIMS Campus, Ansari Nagar East, New Delhi

New Delhi
DELHI
110029
India 
Phone  8696156799  
Fax    
Email  brajesh.ratre@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Brajesh kumar Ratre 
Designation  Associate Professor 
Affiliation  All India Institute Of Medical Sciences- New Delhi 
Address  Dr BR Ambedkar Institute rotary cancer hospital, AIIMS Campus, Ansari Nagar East, New Delhi

New Delhi
DELHI
110029
India 
Phone  8696156799  
Fax    
Email  brajesh.ratre@gmail.com  
 
Source of Monetary or Material Support  
Dr BRA IRCH AIIMS, Ansari Nagar NEW DELHI, 110029  
 
Primary Sponsor  
Name  AIIMS, NEW DELHI 
Address  Ansari Nagar, New Delhi - 110029 
Type of Sponsor  Research institution and hospital 
 
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 Muralidhara P  All India Institute Of Medical Sciences- New Delhi  Pulmonary OT, third floor, new private ward, department of Pulmonary, critical care and sleep medicine. All India institute of medical sciences (AIIMS) Ansari nagar, New Delhi- 110029
New Delhi
DELHI 		 85531341764

mdr1205@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Ethics comitee -AIIMS Delhi  Approved 
Ethics comitee -AIIMS Delhi   Approved 
Ethics comitee -AIIMS Delhi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J984||Other disorders of lung,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Dexmeditomidine group  Dexmeditomidine (0.5mcg/kg) for 10 min, f/b dexmedetomidine infusion (0.5-1.4mcg/kg/hour)will be given before and during bronchoscopy. The duration for which the drug will be administered is till the rigid bronchoscopy gets completed, a maximum up to 2 hours. 
Comparator Agent  Remifentanil group  Remifentanil(1mcg/kg) Intravenous over 10 minutes followed by Remifentanil infusion (0.05-0.25μg/kg/min)will be given before and during bronchoscopy. The duration for which the drug will be administered is till the rigid bronchoscopy gets completed, a maximum up to 2 hours. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Age between 18 to 80 years of age and American Society of
Anesthesiologists (ASA) Physical Status Class I, II and III.
2.Patients undergoing rigid bronchoscopic procedures.
3.Patients giving consent for the procedure. 
 
ExclusionCriteria 
Details  1. ASA - 4 AND 5
2. Severe renal, hepatic or heart failure
3. heart blocks
4.severe obesity
5. allergy to any medications
6.refusal to give consent
7.pregnancy
8.Procedure that takes more than 2 hours. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The change in hemodynamic variables between
the groups during rigid bronchoscopy.
 		 Baseline, during rigid bronchoscopy, every 5minutes after that till bronchoscopy is complete.
5, 10, 15, 30 minutes, 1hour, 2 hours, 4 hours, and 6 hours postop 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
The time needed for patients to meet
postanesthesia care unit discharge criteria
(Aldrete score: 9)
 		 till 6hrs postop 
nausea/vomiting  till 6hrs postop 
postop cough  till 6hrs postop 
time taken for BIS score to reach 80  till 6hrs postop 
Post-op Sore throat   till 6hrs postop 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   21/10/2024 
Date of Study Completion (India) 10/08/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   As a subspecialty of Pulmonary medicine, interventional bronchoscopy has been developing in recent years. Various bronchoscopic procedures include foreign body removal, rigid bronchoscopy, tracheal dilation, Endobronchial ultrasound (EBUS), biopsy of mass etc.
For lung neoplasms, it offers minimally invasive Palliative and therapeutic procedures. In lung cancer cases, the interventional bronchoscopy role has been elevated from “diagnosis priority” to “diagnosis and treatment developed together”. Palliative therapy with bronchoscopy for lung cancer eases dyspnea, relieves airway obstruction, prolongs the survival and improves the quality of life.
Bronchoscopy also plays an important part in the periop period. In the preoperative localization of peripheral pulmonary nodules, the management of tracheoesophageal fistula (TEF)/bronchoesophageal fistula (BEF), and postoperative bronchopleural fistula (BPF), which are complications of lung cancer, Bronchoscopy plays a role.
Rigid bronchoscopy requires some form of anesthesia and various drugs are used for anesthesia. In our study we aim to compare Dexmedetomidine vs remiferntanil with general anesthesia with respect to hemodynamic parameters, postoperative recovery, ponv, cough, and any complications in between the drugs.
 
Close