Clinical trial NCT05975346: 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
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Post Operative Sore Throat
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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


Eligibility criteria: 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).

Primary outcomes:
measure: the incidence and severity of POST
timeFrame: at immediate recovery (0 h), 2, 4, 6, 8, 12 and 24 h post-operatively.
Secondary outcomes:
measure: evaluation of side effects including nausea, vomiting, cough, and dry mouth in both groups.
timeFrame: at immediate recovery (0 h), 2, 4, 6, 8, 12 and 24 h post-operatively.
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
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.
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.