Clinical trial NCT06368843: the Impact of Ketamine Gargling on the Incidence of Post Intubation Sore Throat
Official title: Evaluating the Impact of Ketamine Gargling on Post Intubation Sore Throat: A Randomized Controlled Trial.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Postoperative Sore Throat
Keywords: ketamine gargling
Post-operative sore throat
endotracheal tube complications
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients undergoing appendectomy or cholecystectomy under general anesthesia with endotracheal intubation in Al-Nasiriyah Teaching Hospital.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sore throat
timeFrame: 2, 6, 12, and 24 hrs. postoperatively
Secondary outcomes:
measure: Cough
timeFrame: 2, 6, 12, and 24 hrs. postoperatively
measure: Hoarseness of voice
timeFrame: 2, 6, 12, and 24 hrs. postoperatively
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Ministry of Health
state: Thi-Qar
Study officials:
References:
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.
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.
citation: 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.