NCT04771026

Brief Summary

This study aims to study the effectiveness of preoperatively nebulized dexamethasone in reducing the incidence and severity of Post Operative Sore Throat, POST in patients undergoing surgery under general anesthesia using the Ambu® AuraGainTM SGA device, with secondary aims of determining the effectiveness of dexamethasone in reducing post-operative cough severity and hoarseness of voice

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

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

November 4, 2020

Completed
27 days until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

1.1 years

First QC Date

November 4, 2020

Last Update Submit

September 27, 2023

Conditions

Sore ThroatHoarsenessDexamethasoneSupraglottic Airway Devices

Keywords

DexamethasoneSupraglottic airway devicePost operative Sore throatPost operative hoarseness of voice

Outcome Measures

Primary Outcomes (1)

  • Incidence of POST up to 24 hours post-operatively in patients who received pre-operative nebulized dexamethasone

    Patients will be evaluated using scoring system for sore throat, cough and hoarseness

    up to 24 hours post-operatively

Secondary Outcomes (2)

  • Incidence of cough up to 24 hours post-operatively in patients who received pre-operative nebulized dexamethasone

    up to 24 hours post-operatively

  • Incidence of hoarseness of voice up to 24 hours post-operatively in patients who received pre-operative nebulized dexamethasone

    up to 24 hours post-operatively

Study Arms (2)

Control

NO INTERVENTION

Receiving routine conduct of general anaesthesia for supraglottic airway device

Dexamethasone

EXPERIMENTAL

Receiving pre-operatively single dose nebulised dexamethasone 8mg prior to induction of general anaesthesia

Drug: Dexamethasone

Interventions

DexamethasoneDRUG

Pre-operatively nebuliser dexamethasone 8mg prior to induction of anesthesia

Also known as: Decan
Dexamethasone

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between the ages of 18-70 years
  • American Society of Anaesthesiology (ASA) physical status of 1 and 2
  • Patients undergoing elective procedures under general anaesthesia between the data collection period suitable for SGA device

You may not qualify if:

  • Pre-existing sore throat/hoarseness on pre-operative assessment
  • Patients with history of postoperative nausea or vomiting
  • Recent (2 weeks) upper or lower respiratory tract infection
  • Known hypersensitivity to dexamethasone or on regular steroids
  • Uncontrolled diabetes of capillary blood sugar more than 10mmol/l on pre-operative assessment
  • Morbidly obese with BMI \> 40 kg/m2
  • Procedure exceeding 3 hours duration
  • Procedure requiring prone or Trendelenburg position or manipulation of head post-induction
  • Oral and neck surgeries
  • Pregnant patients
  • Patients with cognitive disabilities
  • Patients requiring nasogastric tube or nasal temperature probe insertion
  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Science Malaysia Hospital

Kubang Kerian, Kelantan, 16150, Malaysia

Location

MeSH Terms

Conditions

PharyngitisHoarseness

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesVoice DisordersLaryngeal DiseasesRespiration DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Respiratory

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • rhendra hardy Mohamad zaini, MD

    Universiti Sains Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 4, 2020

First Posted

February 25, 2021

Study Start

December 1, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)