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

NCT ID: NCT05975346

Last Updated: 2023-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-31

Study Completion Date

2024-01-31

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

Detailed Description

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Conditions

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Post Operative Sore Throat

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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(K) Ketamine group

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

Ketamine

Intervention Type DRUG

description

(S) Saline group

40 patients will receive saline nebulization (5ml).

saline nebulization

Intervention Type OTHER

description

Interventions

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Ketamine

description

Intervention Type DRUG

saline nebulization

description

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

16 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Doaa Ahmed Abdellatif

Resident-anesthesia,ICU and pain manegment department-sohag hospital university

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Doaa A Abdellatif, resident

Role: CONTACT

01119950167

fawzy A Badawy, assistant professor

Role: CONTACT

01004862474

References

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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.

Reference Type BACKGROUND
PMID: 32642112 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36845340 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30100844 (View on PubMed)

Other Identifiers

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soh-Med-23-07-20MS

Identifier Type: -

Identifier Source: org_study_id

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