Electrical Acupoint Stimulation on Gastric Reflux During I-gel Ventilation

NCT ID: NCT07338448

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-12

Study Completion Date

2026-07-31

Brief Summary

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This study will compare the effects of transcutaneous acupoint electrical stimulation versus no stimulation on intraoperative gastric reflux in patients undergoing general anesthesia with i-gel airway device ventilation.

Detailed Description

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Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Electrical stimulation

Electrodes are pasted at the Neiguan, Zusanli, Gongsun, Taichong acupoints and electrical stimulation is given from anesthesia induction to end of surgery

Group Type EXPERIMENTAL

transcutaneous electrical acupoint stimulation

Intervention Type OTHER

electrical stimulation at 2Hz/10Hz is given from induction to end of surgery

electrodes attachment

Intervention Type OTHER

Electrodes are pasted to the skin of Neiguan, Zusanli, Gongsun, Taichong acupoints

Control

Electrodes are pasted at the Neiguan, Zusanli, Gongsun, Taichong acupoints but no electrical stimulation is given

Group Type PLACEBO_COMPARATOR

electrodes attachment

Intervention Type OTHER

Electrodes are pasted to the skin of Neiguan, Zusanli, Gongsun, Taichong acupoints

Interventions

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transcutaneous electrical acupoint stimulation

electrical stimulation at 2Hz/10Hz is given from induction to end of surgery

Intervention Type OTHER

electrodes attachment

Electrodes are pasted to the skin of Neiguan, Zusanli, Gongsun, Taichong acupoints

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* age ≥18 years old
* scheduled for surgery under general anesthesia with igel ventilation

Exclusion Criteria

* American society of anesthesiologists status higher than grade 3
* history of gastrointestinal surgery
* Currently taking acidic medications, or medications that affect gastric acid secretion or gastrointestinal motility
* High risk of reflux or aspiration (e.g., symptomatic gastroesophageal reflux disease or hiatal hernia)
* History of postoperative nausea and vomiting (PONV)
* Intraoperative requirement of Trendelenburg position
* Expected surgery duration exceeding 4 hours
* Contraindications for acupoint electrical stimulation, such as patients with implanted electrophysiological devices, or skin infection/lesions at acupoint sites
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Air Force Military Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Zhihong LU

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Zhihong Lu

Role: CONTACT

86-13891975018

Other Identifiers

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XJH-A-20251021

Identifier Type: -

Identifier Source: org_study_id

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