Clinical trial NCT06297720: Early Oral Hydration After Thoracoscopic Surgery
Official title: Safety and Feasibility of Early Oral Hydration After Video-assisted Thoracoscopic Surgery: A Prospective, Randomized, and Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anesthesia
Intubation Complication
Keywords: Early oral hydration
Sore throat
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: sore throat level by VAS (Visual Analogue Scale)
timeFrame: From patient arrived at the PACU (Postanesthesia Care Unit) to patient being discharged, about 1-3 hours
measure: Mouth dryness
timeFrame: From patient arrived at the PACU (Postanesthesia Care Unit) to patient being discharged, about 1-3 hours
Secondary outcomes:
measure: post-operative nausea and vomiting (PONV)
timeFrame: From patient been sent to PACU (Postanesthesia Care Unit) until discharge, about 1-3 hours
measure: timing of post-operative nausea and vomiting (PONV)
timeFrame: From patient been sent to PACU (Postanesthesia Care Unit) until discharge, about 1-3 hours
measure: duration of post-operative nausea and vomiting (PONV)
timeFrame: From patient been sent to PACU (Postanesthesia Care Unit) until discharge, about 1-3 hours
measure: management of post-operative nausea and vomiting (PONV)
timeFrame: From patient been sent to PACU (Postanesthesia Care Unit) until discharge, about 1-3 hours
measure: Heart Rate in PACU (Postanesthesia Care Unit)
timeFrame: From patient been sent to PACU (Postanesthesia Care Unit) until discharge in every 5 minutes, about 1-3 hours
measure: Blood pressure in PACU (Postanesthesia Care Unit)
timeFrame: From patient been sent to PACU (Postanesthesia Care Unit) until discharge in every 5 minutes, about 1-3 hours
measure: Patient's satisfaction
timeFrame: Through study completion, before patients leaving PACU (Postanesthesia Care Unit)
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: ChangGung MH
Study officials:
affiliation: +886937020809
name: JUN-YU CHEN
role: STUDY_CHAIR
References: