Dexmedetpmidine Versus Ketamine for Postoperative Sore Throat in Sinus Surgery

Phase 3

Completed

• Conditions: Sore Throat
• Interventions: Other: saline 0.9%; Drug: Ketamine; Drug: Dexmedetomidine

• Registration Number: NCT04955158
• Lead Sponsor: Assiut University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-07-01
• Study First Submitted QC: 2021-07-04
• Study First Posted: 2021-07-08
• Study Start: 2021-08-19
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-15
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline placebo	saline 0.9%	20 ml 0.9% saline soaked pharyngeal pack
Ketamine	Ketamine	50 mg ketamine soaked pharyngeal pack
Dexmedetomidine	Dexmedetomidine	75 µg dexmedetomidine soaked pharyngeal pack

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative sore throat (POST)	24 hour after surgery	On arrival in the post anesthesia care unit, the patient was immediately evaluated for the presence of sore throat (time 0 hour) using a standardized scale. The severity of POST was graded on a 4-point scale ranging from 0 to 3; 0 being no sore throat, 1 being mild discomfort (complains only with questioning), 2 being moderate sore throat (complains on their own), and 3 being severe sore throat (change in voice, hoarseness, and throat pain). Evaluations occurred at 0, 1, 2, 4, 6, 12 and 24 hours postoperatively.

Secondary Outcome Measures

Name	Time	Method
Postoperative nausea and vomiting (PONV) score	2 hours postoperative	PONV score was assessed and documented using a Verbal Descriptive Scale, which correlates to visual analog nausea scores, with an objective measure of severity: 0 = no PONV: patient reports no nausea and has had no emesis episodes; 1 = mild PONV: patient reports nausea but declines antiemetic treatment; 2 = moderate PONV: patient reports nausea and accepts antiemetic treatment; and 3 = severe PONV: nausea with any emesis episode (retching or vomiting). The score was obtained at 0, 30, 60, 90, and 120 minutes after PACU arrival; 4 mg IV ondansetron for occurred nausea \& vomiting.

Trial Locations

Locations (1)

Omar Soliman; 🇪🇬 Assuit, Egypt