Non-pharmacological Auditory and Somatosensory Stimulation in Anesthetic Emergence

NCT07339618 | Recruiting DMC

• 1 other identifier: WestChinaHospital 2025（1900）
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

General Anesthetic; Electroencephalographic

Keywords

General anesthesia; Emergence; Verbal stimulation; Somatosensory stimulation; EEG; Recovery of consciousness

Outcome Measures

Primary Outcomes (1)

• Time to first eye opening

  defined as the interval from discontinuation of anesthetic agents to the moment the patient opens both eyes in response to a verbal command and is able to keep them open for at least 5 seconds.

  Perioperative

Secondary Outcomes (11)

• Changes in EEG power

  Perioperative

• Time to target BIS values

  Perioperative

• Extubation time

  Perioperative

• Emergence agitation

  Perioperative

• Sedation depth after extubation

  Perioperative

Study Arms (5)

Verbal Stimulation Group:

ACTIVE COMPARATOR

Behavioral: Verbal Stimulation

Shoulder Tapping Group

EXPERIMENTAL

Behavioral: Shoulder Tapping

Shoulder Shaking Group

EXPERIMENTAL

Behavioral: Shoulder Shaking

Combined Verbal + Shoulder Tapping Group

EXPERIMENTAL

Behavioral: Verbal Stimulation; Behavioral: Shoulder Tapping

Combined Verbal + Shoulder Shaking Group

EXPERIMENTAL

Behavioral: Verbal Stimulation; Behavioral: Shoulder Shaking

Interventions

Verbal Stimulation BEHAVIORAL

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.

Combined Verbal + Shoulder Shaking Group; Combined Verbal + Shoulder Tapping Group; Verbal Stimulation Group:

Shoulder Tapping BEHAVIORAL

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.

Combined Verbal + Shoulder Tapping Group; Shoulder Tapping Group

Shoulder Shaking BEHAVIORAL

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.

Combined Verbal + Shoulder Shaking Group; Shoulder Shaking Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 18 to 65 years, with American Society of Anesthesiologists (ASA) physical status I-III;
• Scheduled for laparoscopic abdominal surgery, including gastric, colorectal, or biliary procedures;

You may not qualify if:

• ASA physical status IV;
• Body mass index (BMI) greater than 30 kg/m²;
• Presence of underlying neurological dysfunction, cognitive impairment, or auditory disorders;
• Neurological, cardiovascular, hepatic, or renal dysfunction;
• Current use of antipsychotic medications or a history of psychiatric illness;
• History of alcohol abuse or substance dependence;
• Exposure to general anesthesia or sedation within 1 month prior to surgery;
• Presence of intracranial implants or a history of epilepsy;
• Known allergy to any drugs used in this study;
• Preoperative use of electronic hearing aids or implanted auditory devices;
• Refusal to participate in the study.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

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Central Study Contacts

Prof. Du

CONTACT

+86 18980602213; duguizhi@scu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 14, 2026
• Study Start: October 11, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)