CTRI/2024/02/062836Not yet recruitingPhase 1/2
To study and compare the effect of preoperative nebulized Magnesium sulphate versus Lignocaine in reducing the incidence of post-operative pharyngo-laryngeal complications in patients undergoing surgery under general anaesthesia with cuffed Endotracheal tube - A prospective triple blind randomised control trial
Supriya1 site in 1 country90 target enrollmentStarted: February 28, 2024Last updated:
Trial Snapshot
- Phase
- Phase 1/2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- To evaluate & compare the effectiveness of nebulized Magnesium sulfate & Lignocaine in:
Study Overview
Brief Summary
We will be nebulizing patients with Magnesium sulfate 250mg and Lignocaine 100 mg over 15 minutes and then follow up patients for developing pharyngolaryngeal complications
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •ASA class I-II BMI 18.5-29.9 Undergoing elective surgeries requiring general anaesthesia with cuffed ETT of duration 60-120 minutes.
Exclusion Criteria
- •Patients refusal for participation in study,hemodynamically unstable pt,history of hypersensitivity to drug used,history of active or recent URTI(last 6 weeks),trauma during intubation,patients on analgesics or steroids.
Outcomes
Primary Outcomes
To evaluate & compare the effectiveness of nebulized Magnesium sulfate & Lignocaine in:
Time Frame: 2 hours,6 hours,12 hours, 24 hours, 48 hours
a.Extubation quality score using 5 points extubation quality score.
Time Frame: 2 hours,6 hours,12 hours, 24 hours, 48 hours
b.Post extubation airway related adverse effects like cough,sore throat,hoarseness.
Time Frame: 2 hours,6 hours,12 hours, 24 hours, 48 hours
Secondary Outcomes
- 1.To access the hemodynamic parameter during surgery & extubation.(2.To access the airway dynamics during surgery & extubation.)
Investigators
Study Sites (1)
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