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Clinical Trials in China / NCT07339618
Recruiting Not applicable

Non-pharmacological Auditory and Somatosensory Stimulation in Anesthetic Emergence

NCT07339618 · tracked via the Priya Life Science China tracker
Sponsor
West China Hospital
Phase
Not applicable
Started
2025-10-11
Last updated
2026-01-14

Condition(s) studied

General AnestheticElectroencephalographic

Investigational drug(s) / intervention(s)

Verbal StimulationShoulder TappingShoulder Shaking

Verbal Stimulation: Patients will wear headphones connected to a voice playback device that delivers pre-recorded verbal stimuli. Each voice message will last approximately 3 seconds, with a speech rate of 200-300 ms per character, and the volume will be set at a normal speaking level (60 dB). After each playback, there will be a 10-second interval before the next repetition, and the verbal stimulus will be played three times per intervention cycle.If the patient shows no eye opening or clear response, the standard verbal stimulation procedure will be repeated after a 3-minute interval, until a response is observed.

Shoulder Tapping: No audio will be played through the patient's headphones. Upon discontinuation of anesthetic agents, the investigator will begin tapping the patient's left shoulder. All operators will receive standardized training to ensure procedural consistency. The tapping frequency will be 2 taps per second, i.e., six taps within 3 seconds, paced using a metronome to maintain rhythm uniformity. Each tapping event (six taps over 3 seconds) will last 3 seconds, followed by a 10-second interval before the next tapping event.

Shoulder Shaking: No audio will be played through the patient's headphones. Upon discontinuation of anesthetic agents, the investigator will begin gently shaking the patient's left shoulder.All investigators will undergo standardized training to ensure consistency of operation. Each shaking event (three shakes within 3 seconds) will last 3 seconds, followed by a 10-second interval before the next shaking event. Each intervention cycle will include three shaking events.

Study summary

This study intends to employ verbal stimulation, tactile stimulation, and kinetic stimulation as interventions during the emergence phase from general anesthesia to facilitate recovery.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: 1. Adult patients aged 18 to 65 years, with American Society of Anesthesiologists (ASA) physical status I-III; 2. Scheduled for laparoscopic abdominal surgery, including gastric, colorectal, or biliary procedures; Exclusion Criteria: 1. ASA physical status IV; 2. Body mass index (BMI) greater than 30 kg/m²; 3. Presence of underlying neurological dysfunction, cognitive impairment, or auditory disorders; 4. Neurological, cardiovascular, hepatic, or renal dysfunction; 5. Current use of antipsychotic medications or a history of psychiatric illness; 6. History of alcohol abuse or substance dependence; 7. Exposure to general anesthesia or sedation within 1 month prior to surgery; 8. Presence of intracranial implants or a history of epilepsy; 9. Known allergy to any drugs used in this study; 10. Preoperative use of electronic hearing aids or implanted auditory devices; 11. Refusal to participate in the study.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
West China Hospital of Sichuan University Chengdu Sichuan Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07339618 on ClinicalTrials.gov ↗ ← All trials in China