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 Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Post Operative Sore Throat

Intervention / Treatment
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* Drug: Ketamine
* Other: saline nebulization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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).

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| (K) Ketamine group<br>40 patients will receive ketamine 50mg (1.0 ml with 4.0 ml of the saline) nebulization | Drug: Ketamine<br>* description<br>|
| (S) Saline group<br>40 patients will receive saline nebulization (5ml). | Other: saline nebulization<br>* description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |