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Not yet recruiting NCT07338448

Electrical Acupoint Stimulation on Gastric Reflux During I-gel Ventilation

No phase Interventional Anesthesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: transcutaneous electrical acupoint stimulation, electrodes attachment.
Who it may be relevant to
Registry conditions: Anesthesia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • pH value at middle-esophageal part at end of surgery [Time frame: at end of surgery]
Secondary outcome measures (5)
  • number of gastric reflux episodes [Time frame: 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]
  • longest duration of gastric reflux episodes [Time frame: 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]
  • percentage of patients suffering postoperative nausea and vomiting by 24 hours after surgery [Time frame: from end of surgery to 24 hours after surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07338448 · XJH-A-20251021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗