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CTRI Number  CTRI/2022/03/041048 [Registered on: 14/03/2022] Trial Registered Prospectively
Last Modified On: 28/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A trial to assess the effectiveness of inhaled glycopyrrolate in improving the visual clarity during insertion of endotracheal tube with the help of fiberscope.  
Scientific Title of Study   A randomised controlled trial to evaluate the effect of inhaled glycopyrrolate in improving the fibreoptic intubating conditions under general anaesthesia  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr M N Pradhan 
Designation  Post graduate 
Affiliation  AIIMS PATNA 
Address  Room no. 506, Department of Anaesthesiology, IPD, AIIMS Patna, Phulwarisarif

Patna
BIHAR
801507
India 
Phone  9008657262  
Fax    
Email  pradhanbangaloremn@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abhyuday Kumar 
Designation  Assistant Professor 
Affiliation  AIIMS PATNA 
Address  Room no. 15, Department of Anaesthesiology, AIIMS Patna, Phulwarisarif

Patna
BIHAR
801507
India 
Phone  9013512403  
Fax    
Email  drabhyu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr M N Pradhan 
Designation  Post graduate 
Affiliation  AIIMS PATNA 
Address  Room no. 506, Department of Anaesthesiology, IPD, AIIMS Patna, Phulwarisarif

Patna
BIHAR
801507
India 
Phone  9008657262  
Fax    
Email  pradhanbangaloremn@gmail.com  
 
Source of Monetary or Material Support  
AIIMS PATNA 
 
Primary Sponsor  
Name  AIIMS PATNA 
Address  Aurangabad road Phulwarisharif Patna Bihar 801507 
Type of Sponsor  Government 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 M N Pradhan  AIIMS Patna  5th and 6th floor OT complex, IPD Building, Department of Anaesthesiology
Patna
BIHAR 		 9008657262

pradhanbangaloremn@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
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 
Comparator Agent  0.9% Normal saline  Nebulization with 0.9% Normal saline 8 ml 20 min before surgery  
Intervention  Inhaled Glycopyrrolate 25 microgram per ml  nebulisation with Glycopyrrolate 8 ml(200 microgram) over 20 minutes before surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA physical status 1 and 2 of either sex undergoing elective surgery
Age of 18 to 65 years
Anticipated difficult airway in which fibreoptic intubation is planned under general anaesthesia 
 
ExclusionCriteria 
Details  Patients in which other modalities of intubation is planned
Airway obstruction 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the degree of airway secretion with or without use of inhaled glycopyrrolate prior to fibreoptic intubation  Intraoperative at the time of fibreoptic intubation 
 
Secondary Outcome  
Outcome  TimePoints 
Time to reach carina
The change in heart rate and blood pressure 20 min after nebulization
Incidence of laryngospasm or bronchospasm post extubation 		 Intra operative during fibreoptic intubation.
Preoperative after starting nebulization
Post extubation 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/03/2022 
Date of Study Completion (India) 28/03/2023 
Date of First Enrollment (Global)  18/03/2022 
Date of Study Completion (Global) 28/03/2023 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Data will be provided on request who will comply to data access agreement.

  6. For how long will this data be available start date provided 01-03-2023 and end date provided 01-04-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   In this study, inhaled glycopyrrolate is used as a premedication inorder to reduce the airway secretions to improve the fibreoptic visual field during nasotracheal intubation.
According to DAS guidelines for awake tracheal intubation,use of systemic antisialogogue is not mandatory, however its also stated that fibrescopy view  may  be improved with antisialogogue.
Inhaled glycopyrrolate ,currently approved for management of COPD has not been evaluated for its anti secretory effect.Hence usage of inhaled glycopyrrolate is expected to have less systemic side effects and thus can be a better alternative to systemic antisialogogue.
 
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