Comparison of Nebulized Ketamine With Nebulized Magnesium Sulfate for the Prevention of Postoperative Sore Throat

Comparison of Nebulized Ketamine With Nebulized Magnesium Sulfate for the Prevention of Postoperative Sore Throat in Adult Surgical Patients Undergoing General Anesthesia: Prospective Randomized Controlled Study

The aim of this study is to compare the efficacy of nebulized ketamine versus nebulized magnesium sulfate in reducing the incidence and severity of POST.

• Primary outcome

  • To compare the incidence of POST method.

• Secondary outcomes

  • Onset, Severity, and duration of POST at 0, 2, 4, 6, 12, 24 hours postoperative.
  • The hemodynamics recording (HR, BP, MBP, pre and post nebulization)
  • Adverse Effects (e.g., sedation, cough, nausea, vomiting, ….)

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Sore Throat
• Intervention / Treatment: Drug: Ketamine nebulizer; Drug: Mg sulfate nebulizer; Drug: Placebo

Detailed Description

Post-operative sore throat (POST) is a common complication seen in patients after general anesthesia with endotracheal intubation although clinicians often regard it as a minor complication. The incidence of POST is estimated to be 21%-65% in different studies . The primary cause of POST is airway irritation and inflammation or trauma caused by an endotracheal tube; however, the airway may be extremely sensitive due to a preexisting comorbid condition. Regardless of its incidence and some preventive measures, POST is listed from the top as patients' most undesirable outcome in the postoperative period. POST is well recognized that reporting of sore throat is affected by the method of questioning that is whether the questions asked directly or indirectly .

The expression of POST constitutes a number of signs and symptoms. For example, sore throat is an ordinary expression of pharyngitis, which by itself can have a number of causes. It may also include a variety of symptoms including pain and discomfort, laryngitis, tracheitis, hoarseness, cough, or dysphagia. This leads to an increase in morbidity and causes further complications in patients .

Various pharmacological and nonpharmacological methods have been tried to decrease the incidence of POST with varying success rates. The pharmacological methods used for the prevention of POST are the use of inhalational, intravenous or topical agents that include beclomethasone gel, magnesium sulfate gargle, ketamine gargle, nebulized ketamine, magnesium sulfate nebulization, and lidocaine spray .

Nebulized medication administration is strongly recommended over intranasal delivery that is inhaled into the lungs and respiratory tract and is an important strategy for various respiratory problems and diseases. It reduces cough, temporary nasal discomfort, and vocal cord irritation. N-methyl-D-aspartate (NMDA) receptors had a crucial part in inflammation and nociception in the body. NMDA receptors exist in both peripheral nervous system (PNS) neurons and the central NS (CNS) .

Ketamine, an NMDA receptor antagonist, is commonly administered as a nebulizer to decline the severity and frequency of POST owing to its antinociceptive and anti-inflammatory properties .

Magnesium is also another NMDA receptor antagonist that plays a significant role in decreasing the incidence of POST. It is used as nebulizer; it is accessible and easily available in hospitals. The efficacy of preoperative nebulization of magnesium sulfate was assessed and found that the incidence and severity of POST were reduced at rest and on swallowing through 24 hours post extubation (8). Some studies showed that ketamine and magnesium can be used for attenuation of postoperative sore throat .

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shahenda AHMED Ali, Resident; Phone Number: 01153378581; Email: Shahenda_ahmed_post@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age from 18 to 65 years old.
• Both sexes.
• American Society of Anesthesiologists (ASA) physical status I-II.

• Elective surgery requiring GA with endotracheal intubation.

  - Exclusion Criteria:

• Surgery involves the oral cavity, nasopharynx, larynx, and neck regions.
• Surgery requires prone position.
• Surgery lasted more than 3 hours.
• History of preoperative sore throat, common cold.
• Anticipated difficult airway.
• Any known allergies to study drugs.
• Recent non-steroidal anti-inflammatory drugs use.
• Pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group	Drug: Placebo; 50 patients will receive preoperative nebulization with 5 ml normal saline.
Experimental: Ketamine group	Drug: Ketamine nebulizer; 50 patients will receive preoperative nebulization with 50 mg ketamine in 5 ml normal saline.
Experimental: Mg sulfate group	Drug: Mg sulfate nebulizer; 50 patients will receive preoperative nebulization with 250 mg magnesium sulfate in 5 ml normal saline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To compare the incidence of Post operative sore throat method.	24 hours

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: January 24, 2026
• First Posted (Actual): February 2, 2026

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 30, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Soh-Med-25-12-7MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No