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Clinical Trials/CTRI/2021/10/037622
CTRI/2021/10/037622Not yet recruitingPhase 3

Evaluation of magnesium sulphate gargle for post operative sore throat in patients undergoing general anaesthesia with endotracheal intubation

Department of Anaesthesia1 site in 1 country52 target enrollmentStarted: November 13, 2021Last updated:

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Enrollment
52
Locations
1
Primary Endpoint
TO EVALUATE THE INCIDENCE AND SEVERITY OF POST OPERATIVE SORE THROAT IN PATIENTS RECEIVING PREOPERATIVE GARGLE OF MAGNESIUM SULPHATE 20MG/KG DILUTED UPTO 30ML WITH NORMAL SALINE UNDERGOING ELECTIVE LAPAROSCOPIC SURGERY UNDER GENERAL ANAESTHESIA WITH ENDOTRACHEAL INTUBATION

Study Overview

Brief Summary

Primary objective - To evaluate the incidence and severity of post- operative sore throat in patients receiving preoperative gargle magnesium sulphate 20 mg/kg diluted upto 30ml with normal saline

undergoing elective laparoscopic surgery under general anaesthesia with endotracheal intubation.

Secondary objective - To evaluate incidence and severity of cough and hoarseness of voice in patients receiving preoperative gargle with magnesium sulphate 20mg/kg diluted upto 30ml with normal

saline in above study population.

Study Design

Study Type
Interventional
Allocation
Permuted block randomization, fixed
Masking
Participant and Investigator Blinded

Eligibility Criteria

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

Inclusion Criteria

  • belonging to ASA physical status 1 and 2 undergoing laparoscopic surgery under general anaesthesia with endotracheal intubation.

Exclusion Criteria

  • patients with difficult airway.
  • patients with a history of pre-operative sore throat , oral surgeries, asthma , diabetes, chronic obstructive pulmonary disease , head and neck surgeries.
  • patient with known allergies to study drug and rescue drugs.
  • duration of surgery <1hour and >4 hours.
  • patient consuming non steroidal anti inflammatory drugs within 24hours prior to the surgery or on systemic / topical steroid therapy or taken steroid drugs within 5 days prior to surgery.

Outcomes

Primary Outcomes

TO EVALUATE THE INCIDENCE AND SEVERITY OF POST OPERATIVE SORE THROAT IN PATIENTS RECEIVING PREOPERATIVE GARGLE OF MAGNESIUM SULPHATE 20MG/KG DILUTED UPTO 30ML WITH NORMAL SALINE UNDERGOING ELECTIVE LAPAROSCOPIC SURGERY UNDER GENERAL ANAESTHESIA WITH ENDOTRACHEAL INTUBATION

Time Frame: AT 0hr, 2hr, 4hr and 24hr

Secondary Outcomes

  • To evaluate incidence and severity of cough and hoarseness of voice in patients receiving preoperative gargle with magnesium sulphate 20mg/kg diluted upto 30ml with normal saline .(at 0hr, 2hr, 4hr and 24hr)

Investigators

Sponsor Class
Government medical college

Study Sites (1)

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