Sedation/Pain Management in Gastrointestinal Endoscopy
Conditions
Interventions
Control Group :Intravenous sufentanil (0.1 µg/kg) and sham taVNS stimulation were administered (with only an initial 30 seconds of weak stimulation). . All patients received an intravenous dose of cip
Experimental Group :Intravenous saline placebo and true taVNS stimulation were administered. Stimulation began before anesthesia induction and continued for 30 minutes before stopping, followed by ane
Placebo Group :Intravenous saline placebo and sham taVNS stimulation were administered (with only an initial 30 seconds of weak stimulation). All patients received an intravenous dose of ciprofol (ind
Sponsors
Guangzhou University of Traditional Chinese Medicine ShunDe Traditional Chinese Medicine Hospital, Foshan, Guangdong
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2. 18 kg/m² <= BMI <= 30 kg/m²; 3. American Society of Anesthesiologists (ASA) physical status classification I-III; 4. Subject voluntarily participates in this trial and plans to undergo gastrointestinal endoscopy simultaneously.
Exclusion criteria
Exclusion criteria: 1. Use of sedatives, analgesics, or psychotropic drugs within 24 hours prior to surgery; 2. History of taVNS treatment or allergy to any drug component; 3. Patients with severe heart, liver, kidney, brain, or lung diseases, such as NYHA heart function class III-IV, Child-Pugh class C, creatinine clearance <30 mL/min, etc.; 4. Endoscopic operation time exceeding 30 minutes or total examination time (from the insertion of the gastroscope to the withdrawal of the colonoscope) exceeding 60 minutes; 5. Pregnant or breastfeeding women; 6. Patients with psychiatric disorders (schizophrenia, mania, bipolar disorder, psychosis, etc.), a history of long-term use of psychotropic drugs, and cognitive impairment; 7. Presence of ear diseases or skin lesions affecting the placement of the taVNS patch, such as acute otitis externa or ear deformities; 8. Contraindications for taVNS such as the presence of a pacemaker or intracranial metallic implants; 9. History of alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative 24-hour recovery quality; | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative 1-hour recovery quality;Incidence and severity of adverse events during the perioperative period;Intraoperative remifentanil dosages at each stage and the use of propofol rescue.;Depth of sedation (Ramsay score);Satisfaction of Endoscopists and Patients;Operational and Recovery Efficiency Indicators;Blind efficacy assessment; | — |
Countries
China
Contacts
Public ContactHaobin Peng
Guangzhou University of Traditional Chinese Medicine ShunDe Traditional Chinese Medicine Hospital, Foshan, Guangdong
Outcome results
None listed