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NCT Number: NCT07338448

Electrical Acupoint Stimulation on Gastric Reflux During 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.

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Key information

Conditions

Anesthesia Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Ige Responsiveness, Atopic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transcutaneous electrical acupoint stimulation

Other

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

electrodes attachment

Other

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

Primary outcomes

  1. pH value at middle-esophageal part at end of surgery

    Time frame: at end of surgery

Secondary outcomes

  1. number of gastric reflux episodes

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

  2. total duration of gastric reflux episodes

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

  3. longest duration of gastric reflux episodes

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

  4. pH value at glottis at the end of surgery

    Time frame: at end of surgery

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

    Time frame: from end of surgery to 24 hours after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Zhihong Lu

CONTACT

[email protected]

86-13891975018

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

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

Acronym: ASGARD-igel

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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