| CTRI Number |
CTRI/2025/10/096109 [Registered on: 15/10/2025] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study comparing two ways of giving a medicine called glycopyrrolate by inhaling or by injection to help make awake intubation easier in adults |
|
Scientific Title of Study
|
Comparative efficacy of inhaled glycopyrrolate and intravenous glycopyrrolate for optimizing awake fibreoptic intubation conditions in adult patients a double blind 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 |
ANISH KRISHNA G |
| Designation |
Junior Resident |
| Affiliation |
Armed Forces Medical College |
| Address |
Dept of Anaesthesiology and Critical Care Armed Forces Medical College
Solapur Road
Pune
Maharashtra 411040
Pune
MAHARASHTRA
411040
India |
| Phone |
7907773692 |
| Fax |
|
| Email |
anishkrishnag@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AJIT BHARDWAJ |
| Designation |
PROFESSOR |
| Affiliation |
Armed Forces Medical College |
| Address |
Dept of Anaesthesiology and Critical Care
Armed Forces Medical College
Solapur Road
Pune
Maharashtra 411040
Wanowarie Pune- 411040
Pune
MAHARASHTRA
411040
India |
| Phone |
8171505533 |
| Fax |
|
| Email |
rainaajit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akash Ray Mohapatra |
| Designation |
CLINICAL TUTOR |
| Affiliation |
Dept of Anaesthesiology and Critical Care AFMC |
| Address |
Dept of Anaesthesiology and Critical Care AFMC
Wanowarie Pune- 411040
Pune
MAHARASHTRA
411040
India |
| Phone |
7276632896 |
| Fax |
|
| Email |
araymohapatra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Critical care
Armed Forces Medical College
Solapur road
Pune
Maharashtra
411040
|
|
|
Primary Sponsor
|
| Name |
ANISH KRISHNA G |
| Address |
Department of Anaesthesia and Critical care
Armed Forces Medical College
Solapur road
Pune
Maharashtra
411040
|
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Akash Ray Mohapatra |
Armed Forces Medical College |
1st floor
Department of anaesthesia and critical care
Solapur Road
Pune
Maharashtra 411040
Pune
MAHARASHTRA |
7276632896
araymohapatra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECAFMCPUNE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ICD T88.4 for difficult intubation |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
inhalation |
administering 50mcg glycopyrrolate once in a patient as per randomisation via inhalational route 30 min prior to intubation |
| Intervention |
intravenous |
administering 0.2mg glycopyrrolate once in a patient as per randomisation via intravenous route 30min prior intubation |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with anticipated difficult airway requiring AFOI
and ASA physical status I to III |
|
| ExclusionCriteria |
| Details |
Allergy to glycopyrrolate
Severe cardiac arrhythmias or uncontrolled tachycardia or bradyarrhythmia
History of chronic respiratory disease affecting on treatment with
anticholinergics
Patients with altered mentation unable to comprehend the procedure
cooperate or give consent
Myasthenia gravis
Patients using Contact lenses
Patients with prostatic diseases
Glaucoma |
|
|
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 efficacy of inhaled and intravenous glycopyrrolate in
improving AFOI conditions, assessed using
Secretion Score
Glottic visualization |
outcome will be accessed immediately while 01min to 10min of intubation time
Intraoperative Haemodynamic parameters will be accessed baseline,15min,30min,45min,60min interval
post op side effects will be monitored 15min after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time taken to reach carina
To evaluate the hemodynamic effects heart rate & blood pressure
changes of both administration routes
To assess patient comfort & adverse effects eg dry mouth
tachycardia
To determine the need for additional interventions such as suctioning or
repeat intubation attempts |
time taken to carina will be noted
Intraoperative Haemodynamic parameters will be accessed baseline,15min,30min,45min,60min interval
post op side effects will be monitored 15min after extubation |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/11/2025 |
| 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="6"
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
|
Awake fibreoptic intubation AFOI is a cornerstone of airway management in patients with anticipated difficult intubation such as those with limited mouth opening cervical spine instability or upper airway tumours This is a double blind randomised controlled trial aims to address this gap by comparing the efficacy of inhaled
glycopyrrolate versus intravenous glycopyrrolate in decreasing secretions The study
hypothesizes that nebulized glycopyrrolate may improve the fiberoptic view of upper
airway and glottis by effectively suppressing airway mucus secretion thereby decreasing
cough enhancing patient comfort and facilitating faster tracheal intubation Inhaled glycopyrrolate is primarily used for chronic obstructive pulmonary disease COPD management due to its bronchodilator effects It offers the advantage of
localized airway effects without significant systemic side effects Limited studies suggest
that inhaled glycopyrrolate may provide effective secretion control for AFOI while reducing
systemic anticholinergic side effects There is a paucity of studies comparing inhaled and intravenous glycopyrrolate
specifically in the context of AFOI If inhaled glycopyrrolate proves effective it may offer
an alternative with fewer systemic side effects and better patient comfort This study will
provide evidence to guide anaesthetic practice in optimizing AFOI conditions |