Early Oral Hydration After Thoracoscopic Surgery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anesthesia; Intubation Complication
• Intervention / Treatment: Behavioral: Oral hydration

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ting Ting Wang, Master; Phone Number: +886978316935; Email: ttwang94anes@gmail.com

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 33380
    • ChangGung MH
    • Contact: JUN-YU CHEN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral hydration; wet swab-ice cube-small amount of water	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.
No Intervention: No hydration; According to routine care, no oral fluid supplementation is provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
Patient's satisfaction	Patient's satisfaction measured by Likert scale (1-5)	Through study completion, before patients leaving PACU (Postanesthesia Care Unit)

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Study Chair: JUN-YU CHEN, +886937020809

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Sore throat; Early oral hydration
• Other Study ID Numbers: 2401110013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No