Evaluation of the Efficacy of Preoperative Ketamine Nebulization on Postoperative Sore Throat Due to Tracheal Intubation for Adult Patients Under General Anesthesia, A Prospective Randomized Controlled Study

Post Operative Sore Throat Clinical Trial

Official title:

Evaluation of the Efficacy of Preoperative Ketamine Nebulization on Postoperative Sore Throat Due to Tracheal Intubation for Adult Patients Under General Anesthesia, A Prospective Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05975346
• Other study ID #: soh-Med-23-07-20MS
• Status: Not yet recruiting
• Start date: August 2023
• Est. completion date: January 2024

Study information

• Verified date: July 2023
• Source: Sohag University
• Contact: Doaa A Abdellatif, resident
• Phone: 01119950167
• Email: doaaahmed[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Sore throat includes specific symptoms such as dysphagia, dysphonia, hoarseness, continuous throat pain, and pharyngeal dryness. Patients rated postoperative sore throat (POST) as the eighth most undesirable outcome in the postoperative period POST has a reported incidence of up to 62% following general anesthesia (GA). The incidence of POST is more common in GA with tracheal intubation than in GA with the supraglottic airway Ketamine is an N-methyl-D-aspartate (NMDA) receptor antagonist and has been used as a gargle for reducing the incidence and severity of POST due to its anti-nociceptive and anti-inflammatory effects

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Gender: All
• Age group: 16 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Age 16-60 years.

2. Of both sex.

3. American Society of Anesthesiologists Physical Status (ASA PS) I-II.

4. Undergoing general anesthesia with endotracheal intubation with surgery duration less than two hours.

Exclusion Criteria:

• a- History of chronic obstructive History of sore throat or upper respiratory tract infection.

b- Intraoral and intrapharyngeal surgery. c- airway disease or Asthma. d- Mallampati grade more than II. e- Known allergic to study drug. f- More than one attempt is required for intubation. g- Hypertensive patients. h- Epileptic patients. i- cerebral palsy or any neurological disorders. j- Psychiatry patients. k- Cardiac patients. l- Perioperative use of anti-inflammatory drugs (Non-steroidal anti-inflammatory drug or steroids).

Related Conditions & MeSH terms

• Pharyngitis
• Post Operative Sore Throat

Intervention

Drug:
• Ketamine
description

Other:
• saline nebulization
description

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

References & Publications (3)

Cairns A, Battleday FM, Velikova G, Brunelli A, Bell H, Favo J, Patella M, Lindner O, Pompili C. General patient satisfaction after elective and acute thoracic surgery is associated with postoperative complications. J Thorac Dis. 2020 May;12(5):2088-2095. doi: 10.21037/jtd-19-3345b. — View Citation

Hailu S, Shiferaw A, Regasa T, Getahun YA, Mossie A, Besha A. Incidence of Postoperative Sore Throat and Associated Factors Among Pediatric Patients Undergoing Surgery Under General Anesthesia at Hawassa University Comprehensive Specialized Hospital, a Prospective Cohort Study. Int J Gen Med. 2023 Feb 18;16:589-598. doi: 10.2147/IJGM.S397519. eCollection 2023. Erratum In: Int J Gen Med. 2023 Apr 06;16:1237-1238. — View Citation

Thomas D, Bejoy R, Zabrin N, Beevi S. Preoperative ketamine nebulization attenuates the incidence and severity of postoperative sore throat: A randomized controlled clinical trial. Saudi J Anaesth. 2018 Jul-Sep;12(3):440-445. doi: 10.4103/sja.SJA_47_18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence and severity of POST	the study is to measure the incidence and severity of POST at immediate recovery (0 h), 2, 4, 6, 8, 12 and 24 h post-operatively. in adult patients undergoing surgery of a duration less than 2h.	at immediate recovery (0 h), 2, 4, 6, 8, 12 and 24 h post-operatively.
Secondary	evaluation of side effects including nausea, vomiting, cough, and dry mouth in both groups.	evaluation of side effects including nausea, vomiting, cough, and dry mouth in both groups.	at immediate recovery (0 h), 2, 4, 6, 8, 12 and 24 h post-operatively.