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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Sore Throat
• Intervention / Treatment: Drug: Gargle with ketamine

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 Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Ministry O Health; Phone Number: 07811593388; Email: hussein.hussein@alayen.edu.iq
• Study Contact Backup: Name: Hussein A Al-Jaberi, PhD; Phone Number: 07730593388; Email: hussein.hussein@alayen.edu.iq

Study Locations

• Iraq
  • Thi-Qar
    • Baghdad, Thi-Qar, Iraq, 00964
      • Ministry of health

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; The patients asked to gargling with ketamine solution in the preoperative waiting area after explain the whole procedure and the goals of the study.; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Al-Azhar University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 25, 2024
• Primary Completion (Estimated): August 15, 2024
• Study Completion (Estimated): September 20, 2024

Study Registration Dates

• First Submitted: April 12, 2024
• First Submitted That Met QC Criteria: April 12, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: ketamine gargling; Post-operative sore throat; endotracheal tube complications
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: Ketamine for POST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will not share any data about the participants with other researchers; but we will share the results after doing our analysis.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes