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The Effect of Dexmedetomidine Combined With Percutaneous Auricular Vagus Nerve Stimulation on Postoperative Nausea and Vomiting in Female Laparoscopic Patients: A Randomized Controlled Trial
Led by Affiliated Hospital of Nantong University · Updated on 2025-12-09
176
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to explore the effects and possible mechanisms of combining dexmedetomidine with transcutaneous auricular vagus nerve stimulation (taVNS) on reducing postoperative nausea and vomiting in female patients undergoing laparoscopic surgery. The study recruits women aged 18 to 65 who are scheduled for elective laparoscopic surgery under general anesthesia and meet specific health criteria. Participants are randomly assigned to one of two groups: the taVNS group receives stimulation via a device placed on the left ear starting 30 minutes before anesthesia induction and continuing until the surgery ends, combined with intravenous dexmedetomidine infusion. The control group receives a sham stimulation device that does not deliver actual stimulation but follows the same schedule, also combined with dexmedetomidine. The double-blind design ensures that both patients and researchers assessing outcomes remain unaware of group assignments. During the study, patients are monitored for the incidence and severity of nausea and vomiting up to 48 hours after surgery, including the frequency of antiemetic and analgesic use. Additional assessments include pain scores, anxiety and depression scales, and monitoring for adverse effects such as hypotension or skin irritation. The primary outcome is the rate of postoperative nausea and vomiting within the first 24 hours. Overall participation includes preoperative assessments, treatment on the day of surgery, and postoperative follow-up to evaluate safety and efficacy.
CONDITIONS
Brief Title
Effects of taVNS Combined With Dexmedetomidine on POVN
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 65
- Scheduled for elective laparoscopic surgery under general anesthesia
- Classified as American Society of Anesthesiologists (ASA) physical status I to II
- Able to understand study procedures and assessment scales, and communicate effectively with researchers
- Willing to participate and provide written informed consent
You will not qualify if you...
- ASA anesthesia classification III or higher
- Poorly controlled hypertension, second degree or higher atrioventricular block, or obesity (BMI > 30 kg/m2)
- Pregnant or breastfeeding
- Known allergy to study drugs, history of traumatic brain injury, or gastrointestinal surgery
- Liver or kidney dysfunction with elevated enzymes or creatinine, alcoholism, drug abuse, mental illness, or recent use of antiemetics, opioids, psychoactive drugs, or corticosteroids within 24 hours before surgery
- Implanted stimulators (pacemakers, vagus nerve stimulators, deep brain stimulators, spinal cord stimulators), cochlear implants, or metal implants except dental
- Skin lesions or dermatological diseases at the stimulation site
- Preoperative heart rate below 50 bpm or sinoatrial node disease or second-degree or higher atrioventricular block
- Inability to cooperate with assessments
- Participation in other clinical trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants receive dexmedetomidine infusion combined with either active or sham transcutaneous auricular vagus nerve stimulation starting 30 minutes before anesthesia induction and continuing until the end of surgery, terminating after removal of the endotracheal tube in the post-anesthesia care unit (PACU).
1 visit (in-person, on surgery day)
Duration - 48 hours postoperatively
Participants are monitored for postoperative nausea, vomiting, pain, and adverse reactions for up to 48 hours after surgery, including assessments at multiple time points.
Assessments at 2, 6, 24, and 48 hours post-surgery
Trial Site Locations
Total: 1 location
1
Affiliated hospital of Nantong University
Nantong, Jiangsu, China, 226001
Actively Recruiting
Research Team
C
Chao-Chao Zhong, M.D.;P.h.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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