Non-pharmacological Auditory and Somatosensory Stimulation in Anesthetic Emergence
NCT ID: NCT07339618
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
205 participants
INTERVENTIONAL
2025-10-11
2027-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Battlefield Acupuncture and Its Use In Multimodal Perioperative Anesthesia Care
NCT04615299
Impact of General Anaesthetics on Excitability of the Peripheral Sensory Nerve
NCT00696254
The Effectiveness of Acupressure for Managing Postoperative Pain and Anxiety in Patients With Thoracoscopic Surgery
NCT04595253
Acupuncture for Recovery and Postoperative Nausea and Vomiting After Middle Ear Surgeries
NCT04748133
The Effectiveness of Acupressure on the Physiological and Psychological Improvement of Patients Undergoing Local Anesthesia
NCT06681519
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Evidence further indicates that the sequence of functional recovery across different brain regions is heterogeneous during emergence. Clinical observations suggest that auditory perception is among the earliest sensory modalities to recover during anesthetic emergence. This phenomenon is of notable clinical significance, as it underlies the longstanding use of auditory interventions-such as calling a patient's name or giving verbal commands-in the operating room. Compared with other sensory modalities such as vision or nociception, auditory pathways regain responsiveness earlier. Although the precise neural mechanisms remain unclear, they are likely related to the auditory system, language processing circuits, and higher-order cortical integration of language. Recent advances in neuroimaging techniques, including electroencephalography (EEG) and functional magnetic resonance imaging (fMRI), provide further support for this perspective. For example, a previous study demonstrated via intracranial recordings that during propofol anesthesia, the core auditory cortex continued to generate early auditory evoked potentials and frequency-following responses to 50 Hz sound stimuli, indicating preserved early cortical responses. Similarly, another study showed that following loss of consciousness, the primary auditory cortex retained rapid responses to auditory input, whereas higher-order cortical responses were markedly attenuated. These findings suggest that auditory cortices can respond to external auditory stimuli even in the early stages of emergence when anesthetic concentrations remain pharmacologically significant, thereby supporting the use of auditory stimulation in facilitating recovery. Moreover, recent studies have investigated how specific linguistic content (e.g., a patient's own name) and acoustic characteristics (e.g., familiar voices) influence emergence quality. One study found that calling a patient's name elicited stronger responses and facilitated awakening more effectively than generic verbal cues. Similarly, another research reported that playback of maternal voice recordings shortened extubation time and reduced the incidence of emergence delirium in pediatric patients.
In addition to auditory stimulation, non-verbal somatosensory interventions are also commonly applied in clinical practice to promote emergence. Nevertheless, research on the role of such non-verbal stimulation in emergence from general anesthesia remains limited. Previous research demonstrated that acupuncture at acupoints such as Renzhong and Yongquan could accelerate the recovery of consciousness after general anesthesia. However, standardized protocols and robust evidence supporting the use of mechanical somatosensory stimulation to facilitate emergence are currently lacking. And its specific stimulation methods, intensity, timing of intervention, and safety parameters remain unclear.
Animal studies demonstrated in that electrical stimulation of glutamatergic neurons in the brainstem parabrachial nucleus can induce recovery of the righting reflex and behavioral arousal in mice under sustained isoflurane anesthesia, accompanied by a marked reduction in electroencephalographic δ waves. Subsequent studies further confirmed that stimulating glutamatergic neurons in the parabrachial nucleus accelerated anesthetic emergence, underscoring the critical role of this brainstem pathway in arousal regulation. The parabrachial nucleus is an important node in the central arousal network; its activation drives norepinephrine and dopamine release from the hypothalamus and brainstem, thereby enhancing cortical arousal. These findings suggest that peripheral somatosensory stimulation may ascend via spinal pathways to brainstem structures, thereby activating ascending arousal centers and accelerating recovery of consciousness. This provides a neurobiological basis for the use of peripheral somatosensory or spinal stimulation as non-invasive awakening strategies; however, clinical trials systematically validating such interventions remain lacking.
Although numerous studies have explored pharmacologic and non-pharmacologic approaches to accelerate emergence from general anesthesia, there is a paucity of randomized controlled trials evaluating the effectiveness and safety of non-verbal somatosensory stimulation. This approach is simple to implement, has a favorable safety profile, and does not increase healthcare costs. Its effects on emergence efficiency, emergence quality, and postoperative complications (e.g., delayed emergence, agitation) warrant systematic investigation, and such findings would provide evidence for clinical guidelines on anesthetic emergence.
Furthermore, electroencephalography (EEG), as a non-invasive method for real-time monitoring of brain function, is widely applied in assessing anesthetic depth and recovery of consciousness. Studies have shown that during emergence from general anesthesia, EEG exhibits characteristic changes, such as a reduction in high-amplitude slow waves, reappearance of α oscillations, and a gradual increase in β activity. Incorporating EEG frequency dynamics into the study design may help elucidate the neural mechanisms by which stimulation interventions modulate the arousal process, offering more direct neurophysiological evidence to optimize both monitoring and intervention strategies during anesthetic emergence.
In summary, the investigators propose to conduct a prospective, randomized controlled clinical trial to systematically investigate, in patients undergoing laparoscopic abdominal surgery under combined intravenous and inhalational general anesthesia, the effects of non-verbal somatosensory stimulation, either alone or in combination with verbal stimulation, compared with the conventional approach of verbal name-calling. Outcomes of interest include postoperative emergence time, quality, and safety. This study aims to provide robust scientific evidence to inform optimized intervention strategies for anesthetic emergence.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Verbal Stimulation Group:
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 Group
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 Group
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.
Combined Verbal + Shoulder Tapping Group
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.
Combined Verbal + Shoulder Shaking Group
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 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Scheduled for laparoscopic abdominal surgery, including gastric, colorectal, or biliary procedures;
Exclusion Criteria
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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
West China Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Guizhi Du
Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Zhang D, Wei Y. Distinct Neural Mechanisms Between Anesthesia Induction and Emergence: A Narrative Review. Anesth Analg. 2025 Jul 1;141(1):162-171. doi: 10.1213/ANE.0000000000007114. Epub 2024 Jun 11.
Sessler CN, Gosnell MS, Grap MJ, Brophy GM, O'Neal PV, Keane KA, Tesoro EP, Elswick RK. The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care unit patients. Am J Respir Crit Care Med. 2002 Nov 15;166(10):1338-44. doi: 10.1164/rccm.2107138.
Riker RR, Picard JT, Fraser GL. Prospective evaluation of the Sedation-Agitation Scale for adult critically ill patients. Crit Care Med. 1999 Jul;27(7):1325-9. doi: 10.1097/00003246-199907000-00022.
Rosow C, Manberg PJ. Bispectral index monitoring. Anesthesiol Clin North Am. 2001 Dec;19(4):947-66, xi. doi: 10.1016/s0889-8537(01)80018-3.
Cooper RM, O'Sullivan E, Popat M, Behringer E, Hagberg CA. Difficult Airway Society guidelines for the management of tracheal extubation. Anaesthesia. 2013 Feb;68(2):217. doi: 10.1111/anae.12139. No abstract available.
Jee D, Park SY. Lidocaine sprayed down the endotracheal tube attenuates the airway-circulatory reflexes by local anesthesia during emergence and extubation. Anesth Analg. 2003 Jan;96(1):293-7, table of contents. doi: 10.1097/00000539-200301000-00058.
Lee S, Sohn JY, Hwang IE, Lee HJ, Yoon S, Bahk JH, Kim BR. Effect of a repeated verbal reminder of orientation on emergence agitation after general anaesthesia for minimally invasive abdominal surgery: a randomised controlled trial. Br J Anaesth. 2023 Apr;130(4):439-445. doi: 10.1016/j.bja.2022.12.009. Epub 2023 Jan 23.
Hughes SW, Crunelli V. Thalamic mechanisms of EEG alpha rhythms and their pathological implications. Neuroscientist. 2005 Aug;11(4):357-72. doi: 10.1177/1073858405277450.
Purdon PL, Pierce ET, Mukamel EA, Prerau MJ, Walsh JL, Wong KF, Salazar-Gomez AF, Harrell PG, Sampson AL, Cimenser A, Ching S, Kopell NJ, Tavares-Stoeckel C, Habeeb K, Merhar R, Brown EN. Electroencephalogram signatures of loss and recovery of consciousness from propofol. Proc Natl Acad Sci U S A. 2013 Mar 19;110(12):E1142-51. doi: 10.1073/pnas.1221180110. Epub 2013 Mar 4.
Lipp M, Schneider G, Kreuzer M, Pilge S. Substance-dependent EEG during recovery from anesthesia and optimization of monitoring. J Clin Monit Comput. 2024 Jun;38(3):603-612. doi: 10.1007/s10877-023-01103-4. Epub 2023 Dec 18.
Moody OA, Zhang ER, Vincent KF, Kato R, Melonakos ED, Nehs CJ, Solt K. The Neural Circuits Underlying General Anesthesia and Sleep. Anesth Analg. 2021 May 1;132(5):1254-1264. doi: 10.1213/ANE.0000000000005361.
Purdon PL, Sampson A, Pavone KJ, Brown EN. Clinical Electroencephalography for Anesthesiologists: Part I: Background and Basic Signatures. Anesthesiology. 2015 Oct;123(4):937-60. doi: 10.1097/ALN.0000000000000841.
Kreuer S, Biedler A, Larsen R, Altmann S, Wilhelm W. Narcotrend monitoring allows faster emergence and a reduction of drug consumption in propofol-remifentanil anesthesia. Anesthesiology. 2003 Jul;99(1):34-41. doi: 10.1097/00000542-200307000-00009.
Song D, White PF. Remifentanil as an adjuvant during desflurane anesthesia facilitates early recovery after ambulatory surgery. J Clin Anesth. 1999 Aug;11(5):364-7. doi: 10.1016/s0952-8180(99)00061-6.
Wang TX, Xiong B, Xu W, Wei HH, Qu WM, Hong ZY, Huang ZL. Activation of Parabrachial Nucleus Glutamatergic Neurons Accelerates Reanimation from Sevoflurane Anesthesia in Mice. Anesthesiology. 2019 Jan;130(1):106-118. doi: 10.1097/ALN.0000000000002475.
Muindi F, Kenny JD, Taylor NE, Solt K, Wilson MA, Brown EN, Van Dort CJ. Electrical stimulation of the parabrachial nucleus induces reanimation from isoflurane general anesthesia. Behav Brain Res. 2016 Jun 1;306:20-5. doi: 10.1016/j.bbr.2016.03.021. Epub 2016 Mar 10.
Gemma M, Nicelli E, Gioia L, Moizo E, Beretta L, Calvi MR. Acupuncture accelerates recovery after general anesthesia: a prospective randomized controlled trial. J Integr Med. 2015 Mar;13(2):99-104. doi: 10.1016/S2095-4964(15)60159-5.
Cao X, Wang B, Liu M, Li J. Effect of recorded mother's voice on emergence delirium in pediatric patients: a systematic review with meta-analysis. J Pediatr (Rio J). 2024 May-Jun;100(3):231-241. doi: 10.1016/j.jped.2023.08.008. Epub 2023 Oct 14.
Jung YS, Paik H, Min SH, Choo H, Seo M, Bahk JH, Seo JH. Calling the patient's own name facilitates recovery from general anaesthesia: a randomised double-blind trial. Anaesthesia. 2017 Feb;72(2):197-203. doi: 10.1111/anae.13688. Epub 2016 Oct 27.
Krom AJ, Marmelshtein A, Gelbard-Sagiv H, Tankus A, Hayat H, Hayat D, Matot I, Strauss I, Fahoum F, Soehle M, Bostrom J, Mormann F, Fried I, Nir Y. Anesthesia-induced loss of consciousness disrupts auditory responses beyond primary cortex. Proc Natl Acad Sci U S A. 2020 May 26;117(21):11770-11780. doi: 10.1073/pnas.1917251117. Epub 2020 May 12.
Nourski KV, Banks MI, Steinschneider M, Rhone AE, Kawasaki H, Mueller RN, Todd MM, Howard MA 3rd. Electrocorticographic delineation of human auditory cortical fields based on effects of propofol anesthesia. Neuroimage. 2017 May 15;152:78-93. doi: 10.1016/j.neuroimage.2017.02.061. Epub 2017 Feb 27.
Bonhomme V, Boveroux P, Brichant JF, Laureys S, Boly M. Neural correlates of consciousness during general anesthesia using functional magnetic resonance imaging (fMRI). Arch Ital Biol. 2012 Jun-Sep;150(2-3):155-63. doi: 10.4449/aib.v150i2.1242.
Zion-Golumbic E, Schroeder CE. Attention modulates 'speech-tracking' at a cocktail party. Trends Cogn Sci. 2012 Jul;16(7):363-4. doi: 10.1016/j.tics.2012.05.004. Epub 2012 May 30.
Brown EN, Lydic R, Schiff ND. General anesthesia, sleep, and coma. N Engl J Med. 2010 Dec 30;363(27):2638-50. doi: 10.1056/NEJMra0808281. No abstract available.
Mashour GA, Palanca BJ, Basner M, Li D, Wang W, Blain-Moraes S, Lin N, Maier K, Muench M, Tarnal V, Vanini G, Ochroch EA, Hogg R, Schwartz M, Maybrier H, Hardie R, Janke E, Golmirzaie G, Picton P, McKinstry-Wu AR, Avidan MS, Kelz MB. Recovery of consciousness and cognition after general anesthesia in humans. Elife. 2021 May 10;10:e59525. doi: 10.7554/eLife.59525.
Song XJ, Hu JJ. Neurobiological basis of emergence from anesthesia. Trends Neurosci. 2024 May;47(5):355-366. doi: 10.1016/j.tins.2024.02.006. Epub 2024 Mar 14.
Patel SR, Ballesteros JJ, Ahmed OJ, Huang P, Briscoe J, Eskandar EN, Ishizawa Y. Dynamics of recovery from anaesthesia-induced unconsciousness across primate neocortex. Brain. 2020 Mar 1;143(3):833-843. doi: 10.1093/brain/awaa017.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
WestChinaHospital 2025（1900）
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.