AnesthesiaNCT06297720
Early Oral Hydration After Thoracoscopic Surgery
A study testing Oral hydration in people with Anesthesia and Intubation Complication, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Intubation Complication
- What is being tested?
- Oral hydration
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Feasibility of Early Oral Hydration After Video-assisted Thoracoscopic Surgery: A Prospective, Randomized, and Controlled Study
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:
- 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.
- 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.
- Conditions
- Anesthesia, Intubation Complication
- Being tested
- Oral hydration
- Keywords
- Early oral hydration, Sore throat
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral hydrationBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Oral hydration | Experimental | wet swab-ice cube-small amount of water Receives: Behavioral: Oral hydration |
| No hydration | No intervention | According to routine care, no oral fluid supplementation is provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
sore throat level by VAS (Visual Analogue Scale)
sore throat level by VAS (Visual Analogue Scale) measured by 0-10 point-scale
Measured: From patient arrived at the PACU (Postanesthesia Care Unit) to patient being discharged, about 1-3 hours
Mouth dryness
Modified Schirmer tear strip test
Measured: 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)
PONV exist or not
Measured: From patient been sent to PACU (Postanesthesia Care Unit) until discharge, about 1-3 hours
timing of post-operative nausea and vomiting (PONV)
PONV or not, if yes, record timing
Measured: From patient been sent to PACU (Postanesthesia Care Unit) until discharge, about 1-3 hours
duration of post-operative nausea and vomiting (PONV)
PONV or not, if yes, record duration
Measured: From patient been sent to PACU (Postanesthesia Care Unit) until discharge, about 1-3 hours
management of post-operative nausea and vomiting (PONV)
PONV or not, if yes, record management
Measured: From patient been sent to PACU (Postanesthesia Care Unit) until discharge, about 1-3 hours
Heart Rate in PACU (Postanesthesia Care Unit)
Heart Rate (/min) in PACU (Postanesthesia Care Unit)
Measured: From patient been sent to PACU (Postanesthesia Care Unit) until discharge in every 5 minutes, about 1-3 hours
Blood pressure in PACU (Postanesthesia Care Unit)
Blood pressure (mmHg) in PACU (Postanesthesia Care Unit)
Measured: From patient been sent to PACU (Postanesthesia Care Unit) until discharge in every 5 minutes, about 1-3 hours
Patient's satisfaction
Patient's satisfaction measured by Likert scale (1-5)
Measured: Through study completion, before patients leaving PACU (Postanesthesia Care Unit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start1 Mar 2024 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- JUN-YU CHEN, Study chair, +886937020809
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297720
- Sponsor's protocol ID
- 2401110013
- Status last verified
- Jan 2024
- First submitted
- 5 Feb 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Early Oral Hydration After Video-assisted Thoracoscopic Surgery: A Prospective, Randomized, and Controlled Study
- ClinicalTrials.gov ID
- NCT06297720
- Acronym / sponsor ID
- 2401110013
- Conditions
- Anesthesia, Intubation Complication
- Keywords
- Early oral hydration, Sore throat
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral hydration | Experimental | Behavioral: Oral hydrationwet swab-ice cube-small amount of water |
| No hydration | No intervention | –According to routine care, no oral fluid supplementation is provided. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Pre-operative throat pain
- Impaired mental status
- Tendency to choke (inc. dysphagia, stroke hx.)
- Nil Per Os (NPO) less than 8 hours
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral 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. | Behavioural | Oral hydration |
Primary outcome
sore throat level by VAS (Visual Analogue Scale)
Time frame: From patient arrived at the PACU (Postanesthesia Care Unit) to patient being discharged, about 1-3 hours
sore throat level by VAS (Visual Analogue Scale) measured by 0-10 point-scale
Mouth dryness
Time frame: From patient arrived at the PACU (Postanesthesia Care Unit) to patient being discharged, about 1-3 hours
Modified Schirmer tear strip test
7 secondary outcomes
post-operative nausea and vomiting (PONV)
Time frame: From patient been sent to PACU (Postanesthesia Care Unit) until discharge, about 1-3 hours
timing of post-operative nausea and vomiting (PONV)
Time frame: From patient been sent to PACU (Postanesthesia Care Unit) until discharge, about 1-3 hours
duration of post-operative nausea and vomiting (PONV)
Time frame: From patient been sent to PACU (Postanesthesia Care Unit) until discharge, about 1-3 hours
management of post-operative nausea and vomiting (PONV)
Time frame: From patient been sent to PACU (Postanesthesia Care Unit) until discharge, about 1-3 hours
Heart Rate 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
Blood pressure 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
Patient's satisfaction
Time frame: Through study completion, before patients leaving PACU (Postanesthesia Care Unit)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JUN-YU CHEN study chair
+886937020809
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral hydration in people with Anesthesia and Intubation Complication, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ting Ting Wang, Master (+886978316935, ttwang94anes@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sore throat level by VAS (Visual Analogue Scale) (time frame: From patient arrived at the PACU (Postanesthesia Care Unit) to patient being discharged, about 1-3 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024; AzTrials last refreshed its copy on 31 Oct 2026.