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

NCT05975346 | Unknown

• 1 other identifier: soh-Med-23-07-20MS
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Post Operative Sore Throat

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

(K) Ketamine group

40 patients will receive ketamine 50mg (1.0 ml with 4.0 ml of the saline) nebulization

Drug: Ketamine

(S) Saline group

40 patients will receive saline nebulization (5ml).

Other: saline nebulization

Interventions

Ketamine DRUG

description

(K) Ketamine group

saline nebulization OTHER

description

(S) Saline group

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• Age 16-60 years.
• Of both sex.
• American Society of Anesthesiologists Physical Status (ASA PS) I-II.
• Undergoing general anesthesia with endotracheal intubation with surgery duration less than two hours.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sohag University: lead

Related 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.

  PMID: 32642112 BACKGROUND

• 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.

  PMID: 36845340 BACKGROUND

• 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.

  PMID: 30100844 BACKGROUND

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Doaa A Abdellatif, resident

CONTACT

01119950167; doaaahmed@med.sohag.edu.eg

fawzy A Badawy, assistant professor

CONTACT

01004862474

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident-anesthesia,ICU and pain manegment department-sohag hospital university

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 3, 2023
• Study Start: August 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: August 3, 2023

Record last verified: 2023-07