Comparing the Effect of Ketamine and Magnesium Sulfate Gargling With Placebo on Post-operative Sore Throat

NCT04705948 | Completed

• 1 other identifier: UTEM POST
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective randomized double-blind study including patients ASA I-II, aged more than 18 years undergoing surgery under general anesthesia (GA) and endotracheal intubation. Patients were randomized allocated into 2 groups: ketamine group received ketamine gargle (0.5 mg/kg up to 30 ml dextrose water) and magnesium group received magnesium sulfate gargle (20 mg/kg up to 30 mL dextrose water ) 15 minutes before the operation. Our primary outcome is sore throat and the secondary judging criteria are cough, dysphonia and satisfaction. A standardized anesthesia protocol was followed for all patients. After extubation, the patients were asked to grade POST, hoarseness, and cough at 15 min, 1h, and 24 h.

Conditions

Postoperative Complications

Keywords

sore throat; Ketamine; magnesium sulfate; endotracheal intubation

Outcome Measures

Primary Outcomes (1)

• severity of post-operative sore throat

  The severity of POST was scored on a three-point score from 0 to 2 (0 = No pain; 1 = Oropharyngeal pain on speaking; 2 = Spontaneous oropharyngeal pain)

  at the twenty-fourth hour postoperatively

Secondary Outcomes (2)

• Patient satisfaction

  at the twenty-fourth hour postoperatively

• the incidence of cough

  at the twenty-fourth hour postoperatively

Study Arms (2)

ketamine group

EXPERIMENTAL

ketamine gargle (0.5 mg/kg up to 30 ml dextrose water) 15 minutes before the operation

Drug: Magnesium sulfate versus ketamine

magnesium sulfate group

EXPERIMENTAL

magnesium sulfate gargle (20 mg/kg up to 30 mL G5%) 15 minutes before the operation.

Drug: Magnesium sulfate versus ketamine

Interventions

Magnesium sulfate versus ketamine DRUG

Magnesium sulfate versus ketamine for of post-operative sore throat after endotracheal intubation

Also known as: postoperative complication

ketamine group; magnesium sulfate group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age is greater than or equal to 18 years
• ASA class 1 or 2
• patients proposed for elective visceral, orthopedic, oncology, ophthalmologic, urologic surgery under general anesthesia with orothracheal intubation

You may not qualify if:

• known allergy to ketamine or maguisuim sulphate
• ASA 3 and more
• cervical surgery
• difficult intubation planned or history of difficult intubation
• malformation of the O.R.L sphere
• the need for multiple laryngoscopies for orotracheal intubation (≥ 2 attempts);
• the need for a postoperative nasogastric tube.

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

Mechaal Benali

Nabeul, Mrezga Hammamet, 8000, Tunisia

Location

MeSH Terms

Conditions

Postoperative Complications; Pharyngitis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• mechaal benali, PROFESSOR

  university manar Tunis tunisia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: January 12, 2021
• Study Start: October 7, 2020
• Primary Completion: February 7, 2021
• Study Completion: February 7, 2021
• Last Updated: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)