Electrical Acupoint Stimulation on Gastric Reflux During I-gel Ventilation

NCT07338448 | Not Yet Recruiting

• 1 other identifier: XJH-A-20251021
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anesthesia

Keywords

acupoint stimulation; general anesthesia; gastric reflux; igel

Outcome Measures

Primary Outcomes (1)

• pH value at middle-esophageal part at end of surgery

  at end of surgery

Secondary Outcomes (5)

• number of gastric reflux episodes

  from intubation of igel to end of surgery, at an average of 2 hours

• total duration of gastric reflux episodes

  from intubation of igel to end of surgery, at an average of 2 hours

• longest duration of gastric reflux episodes

  from intubation of igel to end of surgery, at an average of 2 hours

• pH value at glottis at the end of surgery

  at end of surgery

• percentage of patients suffering postoperative nausea and vomiting by 24 hours after surgery

  from end of surgery to 24 hours after surgery

Study Arms (2)

Electrical stimulation

EXPERIMENTAL

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; Other: electrodes attachment

Control

PLACEBO COMPARATOR

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

Other: electrodes attachment

Interventions

transcutaneous electrical acupoint stimulation OTHER

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

Electrical stimulation

electrodes attachment OTHER

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

Control; Electrical stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

MeSH Terms

Conditions

Gastroesophageal Reflux; Ige Responsiveness, Atopic

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Zhihong Lu

CONTACT

86-13891975018; deerlu23@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 3, 2026
• First Posted: January 13, 2026
• Study Start: January 12, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01