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

Postoperative Sore Throat Clinical Trial

Official title:

Evaluating the Impact of Ketamine Gargling on Post Intubation Sore Throat: A Randomized Controlled Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06368843
• Other study ID #: Ketamine for POST
• Status: Not yet recruiting
• Start date: April 25, 2024
• Est. completion date: September 20, 2024

Study information

• Verified date: April 2024
• Source: Al-Azhar University
• Contact: Ministry O Health
• Phone: 07811593388
• Email: hussein.hussein[@]alayen.edu.iq
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: September 20, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Pharyngitis
• Postoperative Sore Throat

Intervention

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

Locations

Country	Name	City	State
Iraq	Ministry of Health	Baghdad	Thi-Qar

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Iraq, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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