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

NCT06368843 | Not Yet Recruiting FDA Drug

• 1 other identifier: Ketamine for POST
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Sore Throat

Keywords

ketamine gargling; Post-operative sore throat; endotracheal tube complications

Outcome Measures

Primary Outcomes (1)

• Sore throat

  A sore throat is characterized by pain, scratchiness, or irritation in the throat, typically aggravated by swallowing.

  2, 6, 12, and 24 hrs. postoperatively

Secondary Outcomes (2)

• Cough

  2, 6, 12, and 24 hrs. postoperatively

• Hoarseness of voice

  2, 6, 12, and 24 hrs. postoperatively

Study Arms (1)

the 1st group (K group)

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

Drug: Gargle with ketamine

Interventions

Gargle with ketamine DRUG

The patients asked to gargling with ketamine solution in the preoperative waiting area after explain the whole procedure and the goals of the study.

Also known as: Placebo

the 1st group (K group)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The patients undergoing appendectomy or cholecystectomy under general anesthesia with endotracheal intubation in Al-Nasiriyah Teaching Hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Ministry of Health

Baghdad, Thi-Qar, 00964, Iraq

Location

Related Publications (3)

• Christensen AM, Willemoes-Larsen H, Lundby L, Jakobsen KB. Postoperative throat complaints after tracheal intubation. Br J Anaesth. 1994 Dec;73(6):786-7. doi: 10.1093/bja/73.6.786.

  PMID: 7880666 BACKGROUND

• Loeser EA, Bennett GM, Orr DL, Stanley TH. Reduction of postoperative sore throat with new endotracheal tube cuffs. Anesthesiology. 1980 Mar;52(3):257-9. doi: 10.1097/00000542-198003000-00011. No abstract available.

  PMID: 7369513 BACKGROUND

• Al-Qahtani AS, Messahel FM. Quality improvement in anesthetic practice--incidence of sore throat after using small tracheal tube. Middle East J Anaesthesiol. 2005 Feb;18(1):179-83.

  PMID: 15830773 BACKGROUND

MeSH Terms

Interventions

Mouthwashes; Ketamine

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Ministry O Health

CONTACT

07811593388; hussein.hussein@alayen.edu.iq

Hussein A Al-Jaberi, PhD

CONTACT

07730593388; hussein.hussein@alayen.edu.iq

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer in anesthesiology department

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 16, 2024
• Study Start: April 25, 2024
• Primary Completion: August 15, 2024
• Study Completion: September 20, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)