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

Not yet recruiting

• Conditions: Post Operative Sore Throat
• Interventions: Other: saline nebulization; Drug: Ketamine

• Registration Number: NCT05975346
• Lead Sponsor: Sohag University

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-27
• Study First Submitted QC: 2023-07-27
• Last Update Submitted: 2023-07-27
• Study Start: 2023-08
• Study First Posted: 2023-08-03
• Last Update Posted: 2023-08-03
• Primary Completion: 2024-01
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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.

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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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
(S) Saline group	saline nebulization	40 patients will receive saline nebulization (5ml).
(K) Ketamine group	Ketamine	40 patients will receive ketamine 50mg (1.0 ml with 4.0 ml of the saline) nebulization

Primary Outcome Measures

Name	Time	Method
the incidence and severity of POST	at immediate recovery (0 h), 2, 4, 6, 8, 12 and 24 h post-operatively.	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.

Secondary Outcome Measures

Name	Time	Method
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.	evaluation of side effects including nausea, vomiting, cough, and dry mouth in both groups.