NCT06297720

Brief Summary

The goal of this clinical trial is to learn about the safety and feasibility of early oral hydration in patients receiving video-assisted thoracoscopic surgery after general anesthesia. The main questions aims to answer:

  • the safety and feasibility of oral hydration supplementation in the recovery room following general anesthesia.
  • the degree of improvement in sore throat and dry mouth after oral hydration.
  • the side effects and risks of oral hydration supplementation, such as the incidence of postoperative nausea and vomiting.
  • the impact of oral hydration supplementation in the recovery room following general anesthesia on hemodynamics.
  • patient satisfaction with oral hydration supplementation in the recovery room following general anesthesia. Participants will receive a series of oral hydration from swab moistening, and ice cube hydration to water hydration in the recovery room. Researchers will compare with the standard, no-hydration group to see if it is safe and feasible to hydrate patients in the recovery room.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
unknown

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

February 5, 2024

Completed
25 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

March 7, 2024

Status Verified

January 1, 2024

Enrollment Period

12 months

First QC Date

February 5, 2024

Last Update Submit

February 29, 2024

Conditions

AnesthesiaIntubation Complication

Keywords

Early oral hydrationSore throat

Outcome Measures

Primary Outcomes (2)

  • sore throat level by VAS (Visual Analogue Scale)

    sore throat level by VAS (Visual Analogue Scale) measured by 0-10 point-scale

    From patient arrived at the PACU (Postanesthesia Care Unit) to patient being discharged, about 1-3 hours

  • Mouth dryness

    Modified Schirmer tear strip test

    From patient arrived at the PACU (Postanesthesia Care Unit) to patient being discharged, about 1-3 hours

Secondary Outcomes (7)

  • post-operative nausea and vomiting (PONV)

    From patient been sent to PACU (Postanesthesia Care Unit) until discharge, about 1-3 hours

  • timing of post-operative nausea and vomiting (PONV)

    From patient been sent to PACU (Postanesthesia Care Unit) until discharge, about 1-3 hours

  • duration of post-operative nausea and vomiting (PONV)

    From patient been sent to PACU (Postanesthesia Care Unit) until discharge, about 1-3 hours

  • management of post-operative nausea and vomiting (PONV)

    From patient been sent to PACU (Postanesthesia Care Unit) until discharge, about 1-3 hours

  • Heart Rate in PACU (Postanesthesia Care Unit)

    From patient been sent to PACU (Postanesthesia Care Unit) until discharge in every 5 minutes, about 1-3 hours

  • +2 more secondary outcomes

Study Arms (2)

Oral hydration

EXPERIMENTAL

wet swab-ice cube-small amount of water

Behavioral: Oral hydration

No hydration

NO INTERVENTION

According to routine care, no oral fluid supplementation is provided.

Interventions

Oral hydrationBEHAVIORAL

* Researchers moisten the patient's throat with a wet cotton swab. If no nausea or vomiting occurs after five minutes, proceed to the next stage. * Provide an ice cube of potable water for the patient to hold in their mouth. If no nausea or vomiting occurs after ten minutes, proceed to the next stage. * Offer 10-20ml of potable water for the patient to drink under medical supervision. If no nausea or vomiting occurs and the patient requests more water, administer 10-20ml every ten minutes, assessing for any adverse effects each time. The total water intake should not exceed 500ml.

Oral hydration

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females aged 18 to 70.
  • Anesthesia physical status classification III or below
  • Body Mass Index 30 or below
  • Elective video-assisted thoracoscopic surgery

You may not qualify if:

  • Pre-operative throat pain
  • Impaired mental status
  • Tendency to choke (inc. dysphagia, stroke hx.)
  • Nil Per Os (NPO) less than 8 hours
  • Pregnancy
  • Nausea and vomiting in Operating room or Post-anesthesia care unit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ChangGung MH

Taoyuan District, 33380, Taiwan

Location

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • JUN-YU CHEN

    +886937020809

    STUDY CHAIR

Central Study Contacts

Ting Ting Wang, Master

CONTACT

+886978316935ttwang94anes@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2024

First Posted

March 7, 2024

Study Start

March 1, 2024

Primary Completion

February 28, 2025

Study Completion

June 30, 2025

Last Updated

March 7, 2024

Record last verified: 2024-01

Locations

TW(1)