Dexmedetpmidine Versus Ketamine for Postoperative Sore Throat in Sinus Surgery

NCT ID: NCT04955158

Last Updated: 2023-04-13

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-19

Study Completion Date

2023-02-15

Brief Summary

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The aim of this randomized clinical trial is to evaluate the impact of dexmedetomidine versus ketamine soaked pharyngeal packing on postoperative sore throat in functional endoscopic sinus surgery (FESS).

Detailed Description

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A written informed consent was taken from the patients.patients will be randomly assigned to three groups of 40 subjects each; dexmedetomidine or ketamine or saline soaked pharyngeal packs were situated under direct vision. Throat packs made of gauze with a length of 20 cm and a width of 10 cm (folded transverse four times) and medications were diluted with 20 ml normal saline. The packings were placed by the surgeon blinded to the study groups.

1-Dexmedetomidine group: 75 µg dexmedetomidine soaked pharyngeal pack (Group D) putted in the posterior pharyngeal wall after induction of anesthesia and \& endotracheal tube (ETT).

2-Ketamine group: 50 mg ketamine soaked pharyngeal pack (Group K) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.

3-Control group: 20 ml 0.9% saline soaked pharyngeal pack (Group C) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.

Conditions

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Sore Throat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Dexmedetomidine

75 µg dexmedetomidine soaked pharyngeal pack

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

75 µg dexmedetomidine soaked pharyngeal pack (Group D) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.

Ketamine

50 mg ketamine soaked pharyngeal pack

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

50 mg ketamine soaked pharyngeal pack (Group K) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.

Saline placebo

20 ml 0.9% saline soaked pharyngeal pack

Group Type EXPERIMENTAL

saline 0.9%

Intervention Type OTHER

20 ml 0.9% saline soaked pharyngeal pack (Group C) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.

Interventions

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Dexmedetomidine

75 µg dexmedetomidine soaked pharyngeal pack (Group D) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.

Intervention Type DRUG

Ketamine

50 mg ketamine soaked pharyngeal pack (Group K) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.

Intervention Type DRUG

saline 0.9%

20 ml 0.9% saline soaked pharyngeal pack (Group C) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.

Intervention Type OTHER

Other Intervention Names

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Precedex ketalar Normal saline

Eligibility Criteria

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Inclusion Criteria

* Adults of both sex with American Society of Anesthesiologists (ASA) physical status I-II
* Elective functional endoscopic sinus surgery (FESS) with endotracheal intubation.

Exclusion Criteria

* A history of preoperative sore throat.
* Upper respiratory tract illness
* Potentially difficult airway
* Patients with history of neck, respiratory or digestive tract pathology
* Chronic smokers
* Using steroid within the last 48 hour
* Pregnant women
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Omar Makram Soliman

Lecturer of anesthesia and ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Omar Soliman, MD

Role: PRINCIPAL_INVESTIGATOR

Omar makram

Locations

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Omar Soliman

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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Higgins PP, Chung F, Mezei G. Postoperative sore throat after ambulatory surgery. Br J Anaesth. 2002 Apr;88(4):582-4. doi: 10.1093/bja/88.4.582.

Reference Type BACKGROUND
PMID: 12066737 (View on PubMed)

Other Identifiers

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17101486

Identifier Type: -

Identifier Source: org_study_id

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