the Impact of Ketamine Gargling on the Incidence of Post Intubation Sore Throat

Not yet recruiting

• Conditions: Postoperative Sore Throat
• Interventions: Drug: Gargle with ketamine

• Registration Number: NCT06368843
• Lead Sponsor: Al-Azhar University

Brief Summary

Tracheal intubation often causes trauma to the airway mucosa, leading to postoperative sore throat (POST), which has been reported to occur in 21-65% of cases. While considered a minor complication, POST can contribute to postoperative discomfort and patient dissatisfaction.

Detailed Description

Patients have ranked POST as the eighth most adverse effect during the postoperative period. Various methods, both non-pharmacological and pharmacological, have been explored to mitigate POST with varying degrees of success. Non-pharmacological approaches include using smaller-sized endotracheal tubes, lubricating the tube with water-soluble jelly, employing careful airway instrumentation, ensuring intubation after full relaxation, employing gentle oropharyngeal suctioning, minimizing intracuff pressure, and deflating the tracheal tube cuff completely before extubation, all of which have been reported to reduce the incidence of POST.

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-12
• Study First Submitted QC: 2024-04-12
• Last Update Submitted: 2024-04-12
• Study First Posted: 2024-04-16
• Last Update Posted: 2024-04-16
• Study Start: 2024-04-25
• Primary Completion: 2024-08-15
• Study Completion: 2024-09-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Adult patients from both sex and aged between 18 and 45 years.
• All participants were scheduled for elective laparoscopic appendectomy or cholecystectomy under general anesthesia.
• Classified as ASA (American Society of Anesthesiologists) I or II.
• Intubation duration is less than 90 minutes.

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Exclusion Criteria

• Patients classified as ASA III or higher.
• Patients exhibiting symptoms of sore throat prior to entering the operating room, or presenting with any respiratory illness or signs of respiratory infection.
• Patients who smoke.
• Patients with a history of allergy to drugs used in this study.
• Patients who are addicted to steroid drugs (inhaled or oral).
• Patients with predicted difficult airway and intubation, indicated by a Mallampati score of II or higher.
• Obese patients with a BMI exceeding 35.
• Patients with neurological diseases.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
the 1st group (K group)	Gargle with ketamine	the 1st group (K group) consisted of 46 patients who were instructed to gargle with a ketamine solution

Primary Outcome Measures

Name	Time	Method
Sore throat	2, 6, 12, and 24 hrs. postoperatively	A sore throat is characterized by pain, scratchiness, or irritation in the throat, typically aggravated by swallowing.

Secondary Outcome Measures

Name	Time	Method
Cough	2, 6, 12, and 24 hrs. postoperatively	Coughing and bucking while intubated on emergence from general anesthesia unfortunately occurs in approximately 40% of patients
Hoarseness of voice	2, 6, 12, and 24 hrs. postoperatively	Hoarseness of voice is a common complication after tracheal intubation and may be very limiting for a patient after anesthesia.

Trial Locations

Locations (1)

Ministry of Health; 🇮🇶 Baghdad, Thi-Qar, Iraq