To study and compare the efficacy of preoperative Magnesium Sulphate nebulization with Ketamine nebulization In reducing the incidence and severity of post-operative pharyngolaryngeal complications - A prospective triple blinded randomised controlled Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- a. Extubation Quality using 5 point extubation quality score.
Study Overview
Brief Summary
We will be nebulizing patients with magnesium sulfate 250mg and ketamine 50mg over 15 minutes and then follow up patients for developing pharnygolaryngeal complications.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Males and females between the age group 18-60 years.
- •ASA class I-II.
- •Body mass index(BMI) 18.5-29.
- •Undergoing surgeries requiring general anaesthesia with cuffed ETT of duration 60-120 minutes.
Exclusion Criteria
- •Patient’s refusal participation in study.
- •Haemodynamically unstable patients.
- •History of hypertension, asthma, chronic obstructive pulmonary disease(COPD), cardiovascular disease, renal disease, diabetes mellitus, cerebrovascular disease.
- •Patients having known hypersensitivity to drugs under consideration.
- •Patient with three or more attempts at laryngoscopy or bougie for intubation.
- •Patients who sustained trauma while intubation or nasogastric tube insertion as evidenced by blood on cuff after extubation or blood stained secretions while suctioning before extubation.
- •Patient suffering from active or recent (past 6 weeks) upper airway tract infection (preoperative sore throat, cough) and edema/inflammation noticed during laryngoscopy.
- •Surgery requiring placement of nasogastric tube intraopeartively.
- •Patients already on analgesics or steroids (systemic or inhaled).
Outcomes
Primary Outcomes
a. Extubation Quality using 5 point extubation quality score.
Time Frame: 2,4,6,12,24,48 hours
b. Post extubation airway related adverse effects like cough (POC), sore throat (POST) & hoarseness (POH).
Time Frame: 2,4,6,12,24,48 hours
3. To study side effect of study drugs if any.
Time Frame: 2,4,6,12,24,48 hours
4. Patient satisfaction score.
Time Frame: 2,4,6,12,24,48 hours
PRIMARY OBJECTIVES
Time Frame: 2,4,6,12,24,48 hours
1. To Evaluate & compare the effectiveness of nebulised Magnesium sulfate & ketamine in:
Time Frame: 2,4,6,12,24,48 hours
2. To access the airway dynamics during surgery & extubation.
Time Frame: 2,4,6,12,24,48 hours
SECONDARY OBJECTIVES
Time Frame: 2,4,6,12,24,48 hours
1. To access the haemodynamic parameter during surgery & extubation.
Time Frame: 2,4,6,12,24,48 hours
Secondary Outcomes
- SECONDARY OBJECTIVES(1.To access the haemodynamic parameter during surgery and extubation.)