NCT05069844

Brief Summary

This study aims to evaluate the effect preoperative chewing gums for 2 or 4 minutes on postoperative sore throat after general anesthesia using an endotracheal tube.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 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

September 25, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2022

Completed
Last Updated

November 21, 2022

Status Verified

November 1, 2022

Enrollment Period

1.1 years

First QC Date

September 25, 2021

Last Update Submit

November 18, 2022

Conditions

Gum ChewingSore ThroatEndotracheal IntubationRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • The incidence of moderate/severe postoperative sore throat (POST) within 24 hours after surgery POST within 24 hours after surgery

    The incidence of moderate/severe POST within 24 hours after surgery

    24 hours postoperative

Secondary Outcomes (1)

  • Postoperative sore throat (POST) numeric rating scale (NRS) scores 2, 6, and 24 hours after surgery

    24 hours Postoperative

Study Arms (3)

Gum chewing for 2 minutes

EXPERIMENTAL

Patients will chew 1 piece of herbal sugar-free for 2 minutes and then spat it out.

Dietary Supplement: Gum chewing for 2 minutes

Gum chewing for 4 minutes

EXPERIMENTAL

Patients will chew 1 piece of herbal sugar-free for 4 minutes and then spat it out.

Dietary Supplement: Gum chewing for 4 minutes

Control group

NO INTERVENTION

Patients will be asked to swallow 2 times only.

Interventions

Gum chewing for 2 minutesDIETARY_SUPPLEMENT

In the preoperative waiting area before transfer to the operating room, patients will chew 1 piece of herbal sugar-free for 2 minutes and then spat it out.

Gum chewing for 2 minutes
Gum chewing for 4 minutesDIETARY_SUPPLEMENT

In the preoperative waiting area before transfer to the operating room, patients will chew 1 piece of herbal sugar-free for 4 minutes and then spat it out.

Gum chewing for 4 minutes

Eligibility Criteria

Age21 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Age 21-65 years
  • Females
  • American Society of Anesthesiologists (ASA) physical I-II
  • Scheduled for elective breast surgery
  • Under general anesthesia.

You may not qualify if:

  • Chronic laryngitis
  • Chronic bronchitis
  • Asthma
  • Gastroesophageal reflux
  • Allergies to study drugs
  • Recent use of nonsteroidal anti-inflammatory drugs (NSAIDs)
  • A history of upper respiratory tract infection
  • Smoking and steroid therapy in the past week
  • Failure to communicate normally
  • Mallampati grade \>2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute - Egypt

Cairo, 11561, Egypt

Location

MeSH Terms

Conditions

Pharyngitis

Interventions

Chewing Gum

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Plant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesPlant ExudatesBiological ProductsComplex MixturesCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Patients included in the study will be divided into 3 groups; the gum group2 (group G2), the gum group4 (group G4) and the control group (group C) by a computer-generated random number table before surgery.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer of Anesthesiology and Pain Management

Study Record Dates

First Submitted

September 25, 2021

First Posted

October 6, 2021

Study Start

October 1, 2021

Primary Completion

October 25, 2022

Study Completion

October 26, 2022

Last Updated

November 21, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

The data will be available upon reasonable request from the corresponding author

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
One year after the end of the study

Locations

EG(1)