NCT05542823

Brief Summary

The main objective of this study is to evaluate the association between the duration of intraoperative cuff overpressure and the development of postoperative sore throat.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
337

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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 13, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

October 4, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2025

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2025

Completed
Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

2.8 years

First QC Date

September 13, 2022

Last Update Submit

January 8, 2026

Conditions

Laparoscopic SurgeryTracheal Intubation MorbiditySore-throat

Keywords

Laparoscopic surgeryEndotracheal intubationCuff pressureSore throatHoarseness

Outcome Measures

Primary Outcomes (1)

  • Incidence of postoperative sore throat at 24h postoperatively.

    Incidence of postoperative sore throat (score 1 or more) 0 = no sore throat 1. = mild sore throat (less severe 1 = mild sore throat (less severe than with a cold) 2. = moderate sore throat (as with a cold)2 = moderate sore throat (as with a cold) 3. = severe (more severe than with a cold)3 = severe (more severe than with a cold)

    at 24h postoperatively.

Secondary Outcomes (5)

  • Incidence of postoperative sore throat at 1h postoperatively.

    at 1h postoperatively

  • Incidence of postoperative sore throat at 48h postoperatively.

    at 48h postoperatively

  • Incidence of postoperative hoarseness at 1h postoperatively.

    at 1h postoperatively

  • Incidence of postoperative hoarseness at 24h postoperatively.

    at 24h postoperatively.

  • Incidence of postoperative hoarseness at 48h postoperatively.

    at 48h postoperatively

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients undergoing laparoscopic surgery and endotracheal intubation under general anesthesia

You may qualify if:

  • \- Patients undergoing laparoscopic surgery and endotracheal intubation under general anesthesia

You may not qualify if:

  • Patients who already had sore throat and hoarseness before surgery
  • Patients who were expected to have anticipated difficult airway
  • Surgery duration \< 1 hour

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seoul national university hospital

Seoul, Please Select An Option, 03080, South Korea

Location

Hyun-Kyu Yoon

Seoul, South Korea

Location

MeSH Terms

Conditions

PharyngitisHoarseness

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

Study Officials

  • Hyun-Kyu Yoon

    Seoul National University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

September 13, 2022

First Posted

September 16, 2022

Study Start

October 4, 2022

Primary Completion

August 7, 2025

Study Completion

August 10, 2025

Last Updated

January 12, 2026

Record last verified: 2026-01

Locations

KR(2)