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Clinical Trials/CTRI/2023/08/056990
CTRI/2023/08/056990Not yet recruitingNot Applicable

To compare the efficacy of magnesium sulphate gargles and ketamine gargles on incidence and severity of post-operative sore throat following endotracheal intubation.

Dr. Ramesh Kumar P B1 site in 1 country120 target enrollmentStarted: April 9, 2023Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
120
Locations
1
Primary Endpoint
Post-operative sore throat

Study Overview

Brief Summary

Post-operativesore throat (POST) is a common adverse event after general anaesthesia. Thoughconsidered as a minor complication, it may cause significant post-operativemorbidity and patient dissatisfaction. Ketamine, an NMDA receptor antagonist,has been used as gargle, for reducing the incidence and severity of POSTfollowing endotracheal intubation. Magnesium sulphate, also an NMDA receptorantagonist has been recently used as gargle and found to attenuate POST moresignificantly than ketamine.This comparison has been made in patients in whomairway was secured using endotracheal tube. Our study was aimed at assessingand comparing the efficacy of magnesium sulphate and ketamine gargles onincidence and severity of post-operative sore throat following endotrachealintubation.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients requiring general anaesthesia with Proseal laryngeal mask airway.
  • Physical status ASA grade I and II.

Exclusion Criteria

  • 1.Patients with history of pre-operative sore throat, asthma, COPD.
  • 2.Patients requiring oropharyngeal, head and neck surgeries.
  • 3.Patients with Body Mass Index > 30 kg/m
  • 4.Patients with full stomach or abdominal distension.
  • 5.Patients with gastroesophageal reflux disease.
  • 6.Patients with modified mallampatti class IV, anticipated difficult airway.
  • 7.Patients having allergy to study drugs.
  • 8.Patients who have recently received NSAIDS.
  • 9.Patients having nausea and vomiting.
  • 10.Expected duration of surgery more than 2 hours.

Outcomes

Primary Outcomes

Post-operative sore throat

Time Frame: Assessed at 0, 2, 4, 24 hrs post-operatively & graded on a four-point scale

Secondary Outcomes

  • Requirement of Analgesics for POST & Side Effects profile of study drugs.(VAS scoring POST to be assessed at 0,2,6,24 hours post operatively)

Investigators

Sponsor
Dr. Ramesh Kumar P B
Sponsor Class
Other [self]

Study Sites (1)

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