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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06297720
Other study ID # 2401110013
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date June 30, 2025

Study information

Verified date January 2024
Source Chang Gung Memorial Hospital
Contact Ting Ting Wang, Master
Phone +886978316935
Email ttwang94anes@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date June 30, 2025
Est. primary completion date February 28, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 70 Years
Eligibility 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: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
Taiwan ChangGung MH Taoyuan

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 post-operative nausea and vomiting (PONV) PONV exist or not From patient been sent to PACU (Postanesthesia Care Unit) until discharge, about 1-3 hours
Secondary timing of post-operative nausea and vomiting (PONV) PONV or not, if yes, record timing From patient been sent to PACU (Postanesthesia Care Unit) until discharge, about 1-3 hours
Secondary duration of post-operative nausea and vomiting (PONV) PONV or not, if yes, record duration From patient been sent to PACU (Postanesthesia Care Unit) until discharge, about 1-3 hours
Secondary management of post-operative nausea and vomiting (PONV) PONV or not, if yes, record management From patient been sent to PACU (Postanesthesia Care Unit) until discharge, about 1-3 hours
Secondary Heart Rate in PACU (Postanesthesia Care Unit) Heart Rate (/min) in PACU (Postanesthesia Care Unit) From patient been sent to PACU (Postanesthesia Care Unit) until discharge in every 5 minutes, about 1-3 hours
Secondary Blood pressure in PACU (Postanesthesia Care Unit) Blood pressure (mmHg) in PACU (Postanesthesia Care Unit) From patient been sent to PACU (Postanesthesia Care Unit) until discharge in every 5 minutes, about 1-3 hours
Secondary Patient's satisfaction Patient's satisfaction measured by Likert scale (1-5) Through study completion, before patients leaving PACU (Postanesthesia Care Unit)
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