| CTRI Number |
CTRI/2019/02/017716 [Registered on: 19/02/2019] Trial Registered Prospectively |
| Last Modified On: |
01/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of 2 doses of Magnesium sulphate in patients undergoing awake fiberoptic laryngoscopy |
|
Scientific Title of Study
|
A comparative study between two doses of magnesium sulphate as sedative during awake fiberoptic intubation for patients undergoing maxillofacial surgeries: a randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Armaanjeet Singh |
| Designation |
Junior resident |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Anesthesiology
Institute of Medical Sciences
BHU,
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9487245061 |
| Fax |
|
| Email |
dr.armaanjeetsingh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kavita Meena |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Dept of Anesthesiology
IMS BHU
Varanas
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9711897587 |
| Fax |
|
| Email |
kvtamn68@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Armaanjeet Singh |
| Designation |
Junior resident |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Dept of Anesthesiology,
Institute of Medical Sciences
BHU
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9487245061 |
| Fax |
|
| Email |
dr.armaanjeetsingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical SCiences, Banaras Hindu University |
|
|
Primary Sponsor
|
| Name |
IMS BHU |
| Address |
Lanka Nagwa,
Varanasi |
| 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 |
| Armaanjeet Singh |
BHU Trauma Centre |
Operation Theatre Complex,
Dept of Anesthesiology
IMS BHU
Nagwa Lanka
Varanasi
Varanasi
UTTAR PRADESH |
9487245061
dr.armaanjeetsingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S024||Fracture of malar, maxillary and zygoma bones, (2) ICD-10 Condition: S026||Fracture of mandible, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Magnesium Sulphate 30mg/kg |
To administer 30 mg/kg Magnesium sulphate over 15 minutes, 20 minutes before attempting awake fiberoptic laryngoscopy |
| Comparator Agent |
Magnesium sulphate 45mg/kg |
To administer 45 mg/kg magnesium sulphate over 15 minutes, 20 minutes before attempting awake fiberoptic laryngoscopy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade I and II |
|
| ExclusionCriteria |
| Details |
ASA Grade III and IV
Allergy/Hypersensitivity to magnesium sulphate
Cardiac arrhythmia/CHD/Cardiopulmonary disease
Presence of cervical spine |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Ramsay Sedation Score |
During awake fiberoptic laryngoscopy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in blood pressure and heart rate |
During awake fiberoptic laryngoscopy |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2019 |
| Date of Study Completion (India) |
26/07/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a randomized, double blind, parallel group trial comparing the safety and efficacy of Magnesium sulphate 30 mg/kg and Magnesium sulphate 45 mg/kg in 80 patients with maxillofacial injuries undergoing awake fiberoptic laryngoscopy that will be conducted in India. The primary outcome measures will be Ramsay Sedation Score during fiberoptic laryngoscopy. The secondary outcomes will be hemodynamic changes during fiberoptic laryngoscopy
|