| CTRI Number |
CTRI/2025/03/081692 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Low-Dose Atracurium (Muscle Relaxant) on Laryngeal Mask Airway Insertion |
|
Scientific Title of Study
|
Effect of Low-Dose Atracurium on Laryngeal Mask Airway Insertion |
| 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 Hithashree L |
| Designation |
Resident |
| Affiliation |
Kasturba Medical College, Mangaluru, Manipal Academy of Higher Education |
| Address |
Department of Anaesthesiology
203, Kasturba Medical College, Light House Hill Road, Hampankatta, Mangaluru
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7760890272 |
| Fax |
|
| Email |
hithu3695@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil B V |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Mangaluru, Manipal Academy of Higher Education |
| Address |
Department of Anaesthesiology
203, Kasturba Medical College, Light House Hill Road, Hampankatta, Mangaluru
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9620178559 |
| Fax |
|
| Email |
drsunilbv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil B V |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College, Mangaluru, Manipal Academy of Higher Education |
| Address |
Department of Anaesthesiology
203, Kasturba Medical College, Light House Hill Road, Hampankatta, Mangaluru
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9620178559 |
| Fax |
|
| Email |
drsunilbv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education, Manipal, Dakshina Kannada, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Hithashree L |
| Address |
Department of Anaesthesiology
203, Kasturba Medical College, Light House Hill Road, Hampankatta, Mangaluru, Karnataka 575001 |
| 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 |
| Dr Hithashree L |
Kasturba Medical College |
Department of Anaesthesiology
203, Kasturba Medical College, Light House Hill Road, Hampankatta, Mangaluru, Karnataka 575001
Dakshina Kannada
KARNATAKA |
7760890272
hithu3695@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College, Mangaluru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
- Patients above 18 years of age.
- Patients belonging to American Society of Anaesthesiology (ASA) Grade I-II undergoing short surgical procedures.
|
|
| ExclusionCriteria |
| Details |
- Patients unwilling to participate in the study
- Patients with known allergy to general anaesthetic drugs
- Pregnancy
- History of hiatal hernia
- Gastric oesophageal reflux disease
- Full stomach
- Potential for difficult airway management based on physical examination
- Drug or alcohol abuse
- Obesity
- Patients in whom LMA insertion fails and another airway device will be used
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
- Hemodynamic response
- Number of attempts of insertion
- Leakage of ventilation
|
Baseline
1 minute
3 minutes
5 minutes
15 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post-operative sore throat |
After 1 hour
After 4 hours |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/03/2025 |
| 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="2"
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
|
To assess the effect of low-dose atracurium on laryngeal mask airway insertion. To assess the ease of insertion and ventilation in the intra-operative period. To assess the proportion of sore throat in the post-operative period. |