Early Oral Hydration After Thoracoscopic Surgery

Anesthesia Clinical Trial

Official title:

Safety and Feasibility of Early Oral Hydration After Video-assisted Thoracoscopic Surgery: A Prospective, Randomized, and Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06297720
• Other study ID #: 2401110013
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anesthesia
• Intubation Complication

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)