Early Oral Hydration After Thoracoscopic Surgery

NCT ID: NCT06297720

Last Updated: 2024-03-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-06-30

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.

Conditions

Anesthesia; Intubation Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral hydration

wet swab-ice cube-small amount of water

Group Type: EXPERIMENTAL

Oral hydration

Intervention Type: BEHAVIORAL

• 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 hydration

According to routine care, no oral fluid supplementation is provided.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

JUN-YU CHEN

Role: STUDY_CHAIR

+886937020809

Locations

ChangGung MH

Taoyuan District, , Taiwan

Countries

Taiwan

Central Contacts

Ting Ting Wang, Master

Role: CONTACT

ttwang94anes@gmail.com

+886978316935

Facility Contacts

JUN-YU CHEN

Role: primary

Other Identifiers

2401110013

Identifier Type: -

Identifier Source: org_study_id