NCT04955158

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

August 19, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2023

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

1.5 years

First QC Date

July 1, 2021

Last Update Submit

April 11, 2023

Conditions

Sore Throat

Outcome Measures

Primary Outcomes (1)

  • Incidence of postoperative sore throat (POST)

    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.

    24 hour after surgery

Secondary Outcomes (1)

  • Postoperative nausea and vomiting (PONV) score

    2 hours postoperative

Study Arms (3)

Dexmedetomidine

EXPERIMENTAL

75 µg dexmedetomidine soaked pharyngeal pack

Drug: Dexmedetomidine

Ketamine

EXPERIMENTAL

50 mg ketamine soaked pharyngeal pack

Drug: Ketamine

Saline placebo

EXPERIMENTAL

20 ml 0.9% saline soaked pharyngeal pack

Other: saline 0.9%

Interventions

DexmedetomidineDRUG

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

Also known as: Precedex
Dexmedetomidine
KetamineDRUG

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

Also known as: ketalar
Ketamine
saline 0.9%OTHER

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

Also known as: Normal saline
Saline placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Omar Soliman

Asyut, Assuit universi, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 12066737BACKGROUND

MeSH Terms

Conditions

Pharyngitis

Interventions

DexmedetomidineKetamineSodium ChlorideSaline Solution

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Omar Soliman, MD

    Omar makram

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia and ICU

Study Record Dates

First Submitted

July 1, 2021

First Posted

July 8, 2021

Study Start

August 19, 2021

Primary Completion

February 1, 2023

Study Completion

February 15, 2023

Last Updated

April 13, 2023

Record last verified: 2023-04

Locations

EG(1)