General AnestheticNCT07339618
Non-pharmacological Auditory and Somatosensory Stimulation in Anesthetic Emergence
A study testing Verbal Stimulation, Shoulder Tapping and Shoulder Shaking in people with General Anesthetic and Electroencephalographic, run by West China Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- General Anesthetic, Electroencephalographic
- What is being tested?
- Verbal Stimulation, Shoulder Tapping and Shoulder Shaking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteChina
- Study dates
- 11 Oct 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Prof. Du, +86 18980602213, duguizhi@scu.edu.cn
About this study
Official title: Effects of Non-pharmacological Auditory and Somatosensory Stimulation on the Efficiency and Quality of Emergence From General Anesthesia
This study intends to employ verbal stimulation, tactile stimulation, and kinetic stimulation as interventions during the emergence phase from general anesthesia to facilitate recovery.
Read the detailed description
General anesthesia is an indispensable component of modern surgical practice. While its induction mechanisms have been relatively well elucidated, the mechanisms underlying emergence-namely the restoration of consciousness following anesthesia-remain incompletely understood. Emergence from anesthesia represents a critical stage of anesthetic management, with its efficiency and quality directly influencing postoperative recovery, patient safety, and the incidence of complications. Traditionally, anesthesia induction and emergence were considered to be symmetrical and passive processes, with emergence regarded as the reverse of induction that naturally occurs as anesthetic drug concentrations decline. However, recent advances in neuroscience suggest that anesthetic emergence is not merely a passive reversal but rather an actively regulated, multidimensional neurophysiological process with modulatory potential, and it is not entirely symmetrical to induction. Studies have demonstrated that neuronal activity in the cortex, activation patterns of brain regions, and neurotransmitter regulation during emergence differ substantially from those observed during induction. Key regulatory pathways implicated in this process include orexinergic neurons and the locus coeruleus-noradrenergic system. These findings provide a theoretical foundation for strategies aimed at facilitating emergence from general anesthesia.
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
- General Anesthetic, Electroencephalographic
- Being tested
- Verbal Stimulation, Shoulder Tapping, Shoulder Shaking
- Keywords
- General anesthesia, Emergence, Verbal stimulation, Somatosensory stimulation, EEG, Recovery of consciousness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verbal StimulationBehavioural
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 TappingBehavioural
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 ShakingBehavioural
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 group | Role | What they receive |
|---|---|---|
| Verbal Stimulation Group: | Active comparator | Not described Receives: Behavioral: Verbal Stimulation |
| Shoulder Tapping Group | Experimental | Not described Receives: Behavioral: Shoulder Tapping |
| Shoulder Shaking Group | Experimental | Not described Receives: Behavioral: Shoulder Shaking |
| Combined Verbal + Shoulder Tapping Group | Experimental | Not described Receives: Behavioral: Verbal Stimulation; Behavioral: Shoulder Tapping |
| Combined Verbal + Shoulder Shaking Group | Experimental | Not described Receives: Behavioral: Verbal Stimulation; Behavioral: Shoulder Shaking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Perioperative
Secondary outcomes (11)
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
Measured: Perioperative
Time to target BIS values
Time required for the BIS to reach 70, 80, and 90 after discontinuation of desflurane
Measured: Perioperative
Extubation time
Interval from discontinuation of desflurane to removal of the endotracheal tube
Measured: Perioperative
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.
Measured: Perioperative
Sedation depth after extubation
Sedation level assessed using the Richmond Agitation-Sedation Scale (RASS) during emergence from anesthesia.
The RASS ranges from -5 (unarousable) to +4 (combative), with higher scores indicating more agitation and lower scores indicating deeper sedation.
Assessed from extubation to 30 minutes after arrival in the post-anesthesia care unit.
Measured: Perioperative
Hemodynamic parameters
Mean arterial pressure (MAP) and heart rate (HR) recorded
Measured: Perioperative
Length of stay in PACU
Length of stay in PACU
Measured: Perioperative
Postoperative analgesic use
Total amount of analgesic administered in the PACU
Measured: Perioperative
Use of antiemetics
Antiemetic medications administered in the PACU
Measured: Perioperative
Incidence of agitation in the PACU
Proportion of patients with a Riker Sedation-Agitation Scale score ≥ 5. Assessed in the first 30 minutes after arrival in the post-anesthesia care unit.
Measured: Perioperative
Pain scores in the PACU
Pain intensity assessed using the Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst possible pain.
Higher scores indicate more severe pain. Assessed at 10 minutes, 20 minutes, and 30 minutes after arrival in the post-anesthesia care unit.
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start11 Oct 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for General AnestheticStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 205 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guizhi Du, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339618
- Sponsor's protocol ID
- WestChinaHospital 2025(1900)
- Status last verified
- Jan 2026
- First submitted
- 15 Dec 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data will be available upon reasonable request from the corresponding author after publication and ethical approval. Data will be shared via email request to the corresponding author within 6 months after publication.
Publications
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.
PubMed 12421743Riker 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.
PubMed 10446827Rosow 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.
PubMed 11778388Cooper 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.
PubMed 23298360Jee 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.
PubMed 12505969Lee 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.
PubMed 36697272Hughes SW, Crunelli V. Thalamic mechanisms of EEG alpha rhythms and their pathological implications. Neuroscientist. 2005 Aug;11(4):357-72. doi: 10.1177/1073858405277450.
PubMed 16061522Purdon 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.
PubMed 23487781Lipp 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.
PubMed 38108943Moody 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.
PubMed 33857967Purdon 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.
PubMed 26275092Kreuer 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.
PubMed 12826839Song 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.
PubMed 10526805Wang 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.
PubMed 30325744Muindi 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.
PubMed 26971629
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Non-pharmacological Auditory and Somatosensory Stimulation on the Efficiency and Quality of Emergence From General Anesthesia
- ClinicalTrials.gov ID
- NCT07339618
- Acronym / sponsor ID
- WestChinaHospital 2025(1900)
- Conditions
- General Anesthetic, Electroencephalographic
- Keywords
- General anesthesia, Emergence, Verbal stimulation, Somatosensory stimulation, EEG, Recovery of consciousness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 205 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 11 Oct 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study intends to employ verbal stimulation, tactile stimulation, and kinetic stimulation as interventions during the emergence phase from general anesthesia to facilitate recovery.
Detailed description
General anesthesia is an indispensable component of modern surgical practice. While its induction mechanisms have been relatively well elucidated, the mechanisms underlying emergence-namely the restoration of consciousness following anesthesia-remain incompletely understood. Emergence from anesthesia represents a critical stage of anesthetic management, with its efficiency and quality directly influencing postoperative recovery, patient safety, and the incidence of complications. Traditionally, anesthesia induction and emergence were considered to be symmetrical and passive processes, with emergence regarded as the reverse of induction that naturally occurs as anesthetic drug concentrations decline. However, recent advances in neuroscience suggest that anesthetic emergence is not merely a passive reversal but rather an actively regulated, multidimensional neurophysiological process with modulatory potential, and it is not entirely symmetrical to induction. Studies have demonstrated that neuronal activity in the cortex, activation patterns of brain regions, and neurotransmitter regulation during emergence differ substantially from those observed during induction. Key regulatory pathways implicated in this process include orexinergic neurons and the locus coeruleus-noradrenergic system. These findings provide a theoretical foundation for strategies aimed at facilitating emergence from general anesthesia.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verbal StimulationPatients 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. | Behavioural | Combined Verbal + Shoulder Shaking Group, Combined Verbal + Shoulder Tapping Group, Verbal Stimulation Group: |
| Shoulder TappingNo 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. | Behavioural | Combined Verbal + Shoulder Tapping Group, Shoulder Tapping Group |
| Shoulder ShakingNo 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. | Behavioural | Combined Verbal + Shoulder Shaking Group, Shoulder Shaking Group |
Primary outcome
Time to first eye opening
Time frame: Perioperative
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.
11 secondary outcomes
Changes in EEG power
Time frame: Perioperative
Time to target BIS values
Time frame: Perioperative
Extubation time
Time frame: Perioperative
Emergence agitation
Time frame: Perioperative
Sedation depth after extubation
Time frame: Perioperative
Hemodynamic parameters
Time frame: Perioperative
Length of stay in PACU
Time frame: Perioperative
Postoperative analgesic use
Time frame: Perioperative
Use of antiemetics
Time frame: Perioperative
Incidence of agitation in the PACU
Time frame: Perioperative
Pain scores in the PACU
Time frame: Perioperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Background: PubMed 12421743Sessler 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.
- Background: PubMed 10446827Riker 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.
- Background: PubMed 11778388Rosow 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.
- Background: PubMed 23298360Cooper 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.
- Background: PubMed 12505969Jee 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.
- Background: PubMed 36697272Lee 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.
- Background: PubMed 16061522Hughes SW, Crunelli V. Thalamic mechanisms of EEG alpha rhythms and their pathological implications. Neuroscientist. 2005 Aug;11(4):357-72. doi: 10.1177/1073858405277450.
- Background: PubMed 23487781Purdon 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.
- Background: PubMed 38108943Lipp 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.
- Background: PubMed 33857967Moody 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.
- Background: PubMed 26275092Purdon 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.
- Background: PubMed 12826839Kreuer 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.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data will be available upon reasonable request from the corresponding author after publication and ethical approval. Data will be shared via email request to the corresponding author within 6 months after publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verbal Stimulation, Shoulder Tapping and Shoulder Shaking in people with General Anesthetic and Electroencephalographic, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Du (+86 18980602213, duguizhi@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first eye opening (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07339618, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.