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Not yet recruitingNCT06297720Updated Mar 7, 2024

Early Oral Hydration After Thoracoscopic Surgery

An interventional study of Oral hydration in Anesthesia and Intubation Complication, sponsored by Chang Gung Memorial Hospital. Not yet recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-07.

Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2025, 1 year 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
20 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

Anesthesiologists assess the removal of the endotracheal tube post-surgery and the patient is then transferred to the recovery room for rest. The principal investigator will evaluate the consciousness status and risk of nausea and vomiting to confirm eligibility for the trial. Subsequently, the following grouping will be conducted:

  1. Experimental group

    • First, moisten the patient's throat with a cotton swab dipped in water. If no nausea or vomiting occurs after five minutes, proceed to the next stage.
    • Provide an ice cube 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 water for the patient to drink under medical supervision. If no nausea or vomiting occurs and the patient requests more water, administer 10-20ml of water every ten minutes, assessing for any adverse effects each time. The total water intake should not exceed 500ml.
  2. Comparison group - standard care without any intervention

Evaluate the level of throat pain using VAS (Visual Analogue Scale) score, the incidence, timing, frequency of post-operative nausea and vomiting, the level of mouth dryness, the satisfaction of patients in recovery room, and the vital signs.

02

Conditions studied

  • Anesthesia
  • Intubation Complication

Keywords

  • Early oral hydration
  • Sore throat
03

In context

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Oral hydration

    wet swab-ice cube-small amount of water

    Behavioral: Oral hydration

  • No intervention
    No hydration

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

Interventions

  • BehavioralOral hydration

    * 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.

06

What researchers measure

Primary outcomes

  1. sore throat level by VAS (Visual Analogue Scale)

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

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

  2. Mouth dryness

    Modified Schirmer tear strip test

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

Secondary outcomes

  1. post-operative nausea and vomiting (PONV)

    PONV exist or not

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

  2. timing of post-operative nausea and vomiting (PONV)

    PONV or not, if yes, record timing

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

  3. duration of post-operative nausea and vomiting (PONV)

    PONV or not, if yes, record duration

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

  4. management of post-operative nausea and vomiting (PONV)

    PONV or not, if yes, record management

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

  5. Heart Rate in PACU (Postanesthesia Care Unit)

    Heart Rate (/min) in PACU (Postanesthesia Care Unit)

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

  6. Blood pressure in PACU (Postanesthesia Care Unit)

    Blood pressure (mmHg) in PACU (Postanesthesia Care Unit)

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

  7. Patient's satisfaction

    Patient's satisfaction measured by Likert scale (1-5)

    Time frame: Through study completion, before patients leaving PACU (Postanesthesia Care Unit)

07

Study locations

1 site
  • ChangGung MH
    Taoyuan, 33380, Taiwan
    • JUN-YU CHEN · Contact
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06297720
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Sponsor
First posted
Mar 7, 2024
Start date
Mar 1, 2024 (estimated)
Primary completion
Feb 28, 2025 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
Mar 7, 2024

Study contacts

Ting Ting Wang, Master
Contact
ttwang94anes@gmail.com
+886978316935
JUN-YU CHEN
study chair · +886937020809

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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