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

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05975346
Collaborator
(none)
80
5

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
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
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
(K) Ketamine group

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

Drug: Ketamine
description

(S) Saline group

40 patients will receive saline nebulization (5ml).

Other: saline nebulization
description

Outcome Measures

Primary Outcome Measures

  1. 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

  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.]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 60 Years
Sexes Eligible for Study:
All
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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Doaa Ahmed Abdellatif, Resident-anesthesia,ICU and pain manegment department-sohag hospital university, Sohag University
ClinicalTrials.gov Identifier:
NCT05975346
Other Study ID Numbers:
  • soh-Med-23-07-20MS
First Posted:
Aug 3, 2023
Last Update Posted:
Aug 3, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 3, 2023