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

Air Force Military Medical University of People's Liberation Army

Status: Not yet enrolling

Conditions: Anesthesia

Treatments: Other: electrodes attachment; Other: transcutaneous electrical acupoint stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07338448

XJH-A-20251021

Details and patient eligibility

About

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.

Enrollment: 116 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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116 participants in 2 patient groups, including a placebo group

Electrical stimulation

Experimental group

Description:

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

Treatment:

Other: transcutaneous electrical acupoint stimulation

Other: electrodes attachment

Control

Placebo Comparator group

Description:

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

Treatment:

Other: electrodes attachment