| CTRI Number |
CTRI/2024/05/067158 [Registered on: 10/05/2024] Trial Registered Prospectively |
| Last Modified On: |
08/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To assess the use of lignocaine alone versus lignocaine and magnesium sulphate together in nebulizing patients with predicted difficult airway for awake fiberoptic- guided nasotracheal intubation |
|
Scientific Title of Study
|
Assessment of intubating conditions with combined Lignocaine and Magnesium Sulphate nebulization versus Lignocaine alone for awake fiberoptic- guided nasotracheal intubation in patients with anticipated difficult airway |
| 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 Archana A |
| Designation |
PG Resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar West, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9791679080 |
| Fax |
|
| Email |
archana.chutty@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suman Saini |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar West, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9891228793 |
| Fax |
|
| Email |
drsainisumannony@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Archana A |
| Designation |
PG Resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar West, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9791679080 |
| Fax |
|
| Email |
archana.chutty@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive Care, Ground floor, Main OT building, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar west, New Delhi |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar West, New Delhi |
| Type of Sponsor |
Government medical college |
|
|
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 Archana A |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Department of Anaesthesia and Intensive Care, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar West, New Delhi
New Delhi
DELHI |
9791679080
archana.chutty@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Protocol Review Committee IPRC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: J398||Other specified diseases of upperrespiratory tract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lignocaine and Magnesium sulphate nebulization |
Nebulization with 4ml of 4% lignocaine and 2ml of Magnesium sulphate 1g (50% w/v) for 20 minutes |
| Comparator Agent |
Lignocaine nebulization |
Nebulization with 4ml of 4% Lignocaine and 2ml of Normal saline for 20 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18-65 years, belonging to American Society of Anaesthesiologists (ASA) physical status I - II with anticipated difficult airway and planned to undergo nasotracheal intubation. |
|
| ExclusionCriteria |
| Details |
Patients with known allergy to local anaesthetics and glottic/ sub glottic obstruction. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cough score |
From the time FOB is inserted in nostril until intubation is accomplished |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vocal cord position |
During the time of intubation |
| Intubation time |
Time from insertion of FOB in the nostril till the appearance of capnogram on the monitor |
| Supplemental dose of midazolam and Local anaesthetic (spray as you go) |
During intubation time |
| Patient comfort score and operator statisfaction score |
During intubation time |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/05/2024 |
| 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 Applicable |
| 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
|
Considering the additional benefits of Magnesium sulphate nebulization, we decided to use it as an adjunct to lignocaine to facilitate awake fiberoptic-guided nasotracheal intubation. As there is paucity of literature on the use of nebulised Magnesium sulphate for awake fiberoptic- guided nasotracheal intubation, this study has been planned to compare intubating conditions achieved using combined Lignocaine- Magnesium sulphate with Lignocaine alone for awake fiberoptic-guided nasotracheal intubation in patients with anticipated difficult airway. |