the Impact of Ketamine Gargling on the Incidence of Post Intubation Sore Throat

NCT ID: NCT06368843

Last Updated: 2024-04-16

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

NOT_YET_RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-25

Study Completion Date

2024-09-20

Brief Summary

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Tracheal intubation often causes trauma to the airway mucosa, leading to postoperative sore throat (POST), which has been reported to occur in 21-65% of cases. While considered a minor complication, POST can contribute to postoperative discomfort and patient dissatisfaction.

Detailed Description

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Patients have ranked POST as the eighth most adverse effect during the postoperative period. Various methods, both non-pharmacological and pharmacological, have been explored to mitigate POST with varying degrees of success. Non-pharmacological approaches include using smaller-sized endotracheal tubes, lubricating the tube with water-soluble jelly, employing careful airway instrumentation, ensuring intubation after full relaxation, employing gentle oropharyngeal suctioning, minimizing intracuff pressure, and deflating the tracheal tube cuff completely before extubation, all of which have been reported to reduce the incidence of POST.

Conditions

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Postoperative Sore Throat

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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the 1st group (K group)

the 1st group (K group) consisted of 46 patients who were instructed to gargle with a ketamine solution

Gargle with ketamine

Intervention Type DRUG

The patients asked to gargling with ketamine solution in the preoperative waiting area after explain the whole procedure and the goals of the study.

Interventions

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Gargle with ketamine

The patients asked to gargling with ketamine solution in the preoperative waiting area after explain the whole procedure and the goals of the study.

Intervention Type DRUG

Other Intervention Names

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Placebo

Eligibility Criteria

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Inclusion Criteria

* Adult patients from both sex and aged between 18 and 45 years.
* All participants were scheduled for elective laparoscopic appendectomy or cholecystectomy under general anesthesia.
* Classified as ASA (American Society of Anesthesiologists) I or II.
* Intubation duration is less than 90 minutes.

Exclusion Criteria

* Patients classified as ASA III or higher.
* Patients exhibiting symptoms of sore throat prior to entering the operating room, or presenting with any respiratory illness or signs of respiratory infection.
* Patients who smoke.
* Patients with a history of allergy to drugs used in this study.
* Patients who are addicted to steroid drugs (inhaled or oral).
* Patients with predicted difficult airway and intubation, indicated by a Mallampati score of II or higher.
* Obese patients with a BMI exceeding 35.
* Patients with neurological diseases.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Hussein Ali

lecturer in anesthesiology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ministry of Health

Baghdad, Thi-Qar, Iraq

Site Status

Countries

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Iraq

Central Contacts

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Ministry O Health

Role: CONTACT

07811593388

Hussein A Al-Jaberi, PhD

Role: CONTACT

07730593388

References

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Christensen AM, Willemoes-Larsen H, Lundby L, Jakobsen KB. Postoperative throat complaints after tracheal intubation. Br J Anaesth. 1994 Dec;73(6):786-7. doi: 10.1093/bja/73.6.786.

Reference Type BACKGROUND
PMID: 7880666 (View on PubMed)

Loeser EA, Bennett GM, Orr DL, Stanley TH. Reduction of postoperative sore throat with new endotracheal tube cuffs. Anesthesiology. 1980 Mar;52(3):257-9. doi: 10.1097/00000542-198003000-00011. No abstract available.

Reference Type BACKGROUND
PMID: 7369513 (View on PubMed)

Al-Qahtani AS, Messahel FM. Quality improvement in anesthetic practice--incidence of sore throat after using small tracheal tube. Middle East J Anaesthesiol. 2005 Feb;18(1):179-83.

Reference Type BACKGROUND
PMID: 15830773 (View on PubMed)

Other Identifiers

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Ketamine for POST

Identifier Type: -

Identifier Source: org_study_id

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