| CTRI Number |
CTRI/2024/05/067114 [Registered on: 09/05/2024] Trial Registered Prospectively |
| Last Modified On: |
08/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of face mask ventilation efficiency with early or late administration of muscle relaxant for better airway management: Double blinded randomised control study
|
|
Scientific Title of Study
|
Comparison of face mask ventilation efficiency before and after neuromuscular blockade: Double blinded randomised control study
|
| 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 Varun Kumar S |
| Designation |
Resident |
| Affiliation |
Sri Ramachandra Medical College and Research Hospital |
| Address |
Anaesthesiology Department, Udayar Block and G block, Sri Ramachandra Medical College and Research Hospital, Porur, Chennai-600116
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
9952952255 |
| Fax |
|
| Email |
varun27395@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayaraman V |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Medical College and Research Hospital |
| Address |
Anaethesiology Department, Udayar block and G block, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai-600116.
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
9841219820 |
| Fax |
|
| Email |
vjram2001@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varun Kumar S |
| Designation |
Resident |
| Affiliation |
Sri Ramachandra Medical College and Research Hospital |
| Address |
Anaesthesiology department, Udayar block and G block, Sri Ramachandra Medical College and Research Hospital, Sri Ramachandra University, Porur, Chennai-600116
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
9952952255 |
| Fax |
|
| Email |
varun27395@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Medical College and Research Hospital, Porur, Chennai-600116 |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Medical College and Research Hospital |
| Address |
Sri Ramachandra University Porur, Chennai-600116 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Varun Kumar S |
Sri Ramachandra Medical College and Research Hospital |
OR Complex Udayar block and OT Complex 5th, 4th and 3rd floors G block, Anaesthesiology Department, Porur, Chennai-600116
Thiruvallur
TAMIL NADU |
9952952255
varun27395@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Giving NMBD after checking mask ventilation |
After checking ventilation status, the NMBD is given as 0.1mg/kg for Vecuronium or 0.5mg/kg for Atracurium as bolus and the patient is ventilated for 3 minutes |
| Intervention |
Giving NMBD before checking mask ventilation |
After inducing the patient, the NMDB is also given as bolus of 0.1mg/kg for Vecuronium or 0.5mg/kg for Atracurium without checking status and the patient is ventilated for 3 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of either gender aged 18-65 years of ASA I and II posted for elective surgery under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
Anticipated difficult airway
Patient refusal
Allergy to the study drug
|
|
|
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 |
| Vte at 30, 60, 90, 120, 150 and 180s for a total of 180s of face mask ventilation after cessation of response using mechanical ventilator. |
At 30, 60, 90, 120, 150 and 180 seconds |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Han’s grading for face mask ventilation |
During apneic ventilation |
| Intubation time |
From laryngoscopy to appreance of first capnography wave |
| Ease of laryngoscopy (vocal cord movement, limb movement, and coughing) |
Throughtout intubation |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/05/2024 |
| Date of Study Completion (India) |
27/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Face mask ventilation is essential for general anaesthesia and rescue oxygenation in terms of airway management. The estimated incidence of difficult face mask ventilation is 1%–1.5%. There are methods to improve face mask ventilation, of which neuromuscular blocking drugs (NMBDs) are also reported. But in practice, a NMBD is generally given only after confirmation of satisfactory facemask ventilation. This study hypothesizes that a NMBD will improve face mask ventilation in a patient with a normal airway.
|