A clinical trial to study the effects of 2 doses of Magnesium sulphate in patients undergoing awake fiberoptic laryngoscopy

Completed

• Conditions: Fracture of malar, maxillary and zygoma bones, (2) ICD-10 Condition: S026||Fracture of mandible,

• Registration Number: CTRI/2019/02/017716
• Lead Sponsor: IMS BHU

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-03
• Last Update Posted: 2019-01-12
• Study Completion: 2019-07-26

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

ASA Grade I and II.

Exclusion Criteria

ASA Grade III and IV Allergy/Hypersensitivity to magnesium sulphate Cardiac arrhythmia/CHD/Cardiopulmonary disease Presence of cervical spine.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Ramsay Sedation Score	During awake fiberoptic laryngoscopy

Secondary Outcome Measures

Name	Time	Method
Changes in blood pressure and heart rate	During awake fiberoptic laryngoscopy

Trial Locations

Locations (1)

BHU Trauma Centre; 🇮🇳 Varanasi, UTTAR PRADESH, India

BHU Trauma Centre

🇮🇳Varanasi, UTTAR PRADESH, India

Armaanjeet Singh

Principal investigator

9487245061

dr.armaanjeetsingh@gmail.com