Health TrialsbyHealthPanel

Non-pharmacological Auditory and Somatosensory Stimulation in Anesthetic Emergence

ConditionsGeneral AnestheticElectroencephalographic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorWest China Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

Treatment groups

205 Participants
are divided into 5 treatment groups
Group A: Verbal Stimulation Group:Active comparator 1 intervention
Group B: Shoulder Tapping GroupExperimental treatment 1 intervention
Group C: Shoulder Shaking GroupExperimental treatment 1 intervention
Group D: Combined Verbal + Shoulder Tapping GroupExperimental treatment 2 interventions
Group E: Combined Verbal + Shoulder Shaking GroupExperimental treatment 2 interventions

Trial outcomes

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.

Time frame
Perioperative

Secondary outcomes

1

Changes in EEG power

Alterations in power across specific EEG frequency bands (e.g., Delta, Theta, Alpha, Beta) at the time of first eye opening

Time frame
Perioperative
2

Time to target BIS values

Time required for the BIS to reach 70, 80, and 90 after discontinuation of desflurane

Time frame
Perioperative
3

Extubation time

Interval from discontinuation of desflurane to removal of the endotracheal tube

Time frame
Perioperative
4

Emergence agitation

Highest score on the Riker Sedation-Agitation Scale (SAS) observed during emergence. The SAS ranges from 1 to 7, with higher scores indicating greater agitation and a worse outcome. Assessed from extubation to time before arrival in the post-anesthesia care unit.

Time frame
Perioperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

West China Hospital

Lead sponsor

Source ClinicalTrials.gov
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