Electrical Acupoint Stimulation on Gastric Reflux During I-gel Ventilation (ASGARD-igel)

January 3, 2026 updated by: Zhihong LU, Air Force Military Medical University, China

The Effect of Electrical Acupoint Stimulation on Gastric Reflux During Anesthesia With I-gel Ventilation

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electrical stimulation
Electrodes are pasted at the Neiguan, Zusanli, Gongsun, Taichong acupoints and electrical stimulation is given from anesthesia induction to end of surgery
Other: transcutaneous electrical acupoint stimulation
electrical stimulation at 2Hz/10Hz is given from induction to end of surgery
Other: electrodes attachment
Electrodes are pasted to the skin of Neiguan, Zusanli, Gongsun, Taichong acupoints
Placebo Comparator: Control
Electrodes are pasted at the Neiguan, Zusanli, Gongsun, Taichong acupoints but no electrical stimulation is given
Other: electrodes attachment
Electrodes are pasted to the skin of Neiguan, Zusanli, Gongsun, Taichong acupoints

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pH value at middle-esophageal part at end of surgery
Time Frame: at end of surgery
at end of surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
number of gastric reflux episodes
Time Frame: from intubation of igel to end of surgery, at an average of 2 hours
from intubation of igel to end of surgery, at an average of 2 hours
total duration of gastric reflux episodes
Time Frame: from intubation of igel to end of surgery, at an average of 2 hours
from intubation of igel to end of surgery, at an average of 2 hours
longest duration of gastric reflux episodes
Time Frame: from intubation of igel to end of surgery, at an average of 2 hours
from intubation of igel to end of surgery, at an average of 2 hours
pH value at glottis at the end of surgery
Time Frame: at end of surgery
at end of surgery
percentage of patients suffering postoperative nausea and vomiting by 24 hours after surgery
Time Frame: from end of surgery to 24 hours after surgery
from end of surgery to 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Air Force Military Medical University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 12, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

January 3, 2026

First Submitted That Met QC Criteria

January 3, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 3, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJH-A-20251021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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