Stellate Ganglion BlockNCT07274683
Stellate Ganglion Block on Postoperative Sleep Status in Patients With Prolonged Disorders of Consciousness
A study testing stellate ganglion block with 0.5% ropivacaine in people with Stellate Ganglion Block and Prolonged Disorders of Consciousness, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
This is a prospective, single-centre, single-arm, self-controlled, exploratory pilot study. The goal of this clinical trial is to learn about the effect of preoperative administration of stellate ganglion block on postoperative sleep status in patients with prolonged disorders of consciousness. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stellate Ganglion Block, Prolonged Disorders of Consciousness, Sleep
- What is being tested?
- stellate ganglion block with 0.5% ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to Dec 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
- Aged 18-65 years;
- Prolonged disorders of consciousness after acquired brain injury;
- Scheduled to undergo spinal cord electronic stimulator implantation under general anesthesia;
- The skull is intact;
- Informed consent is obtained;
Who cannot join
- Continuous sedation therapy is performed within 72 hours prior to the study;
- The integrity of brain structure is disrupted due to causes such as open head injury and cerebral parenchymal resection;
- Decreased intracranial compliance caused by hydrocephalus and other reasons;
- Airway stenosis or severe dysfunction of ventilation or gas exchange due to various causes;
- Known or suspected severe cardiac, pulmonary, and renal dysfunction;
- History of sedative drug allergy;
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- Complicated by other mental or neurological disorders;
- Local anesthetic allergy;
- Other reasons for ineligibility in this study;
- Informed consent is not obtained;
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Stellate Ganglion Block on Postoperative Sleep Status in Patients With Prolonged Disorders of Consciousness
This is a prospective, single-centre, single-arm, self-controlled, exploratory pilot study.
The goal of this clinical trial is to learn about the effect of preoperative administration of stellate ganglion block on postoperative sleep status in patients with prolonged disorders of consciousness. The main aims to answer are: To explore the feasibility and safety of unilateral SGB in pDOC patients, evaluate its impact on sleep time and sleep architecture from the preoperative night to the night of surgery, compare the cerebral hemodynamic parameters, cerebral oxygen saturation and Coma Recovery Scale-Revised (CRS-R) scores in pDOC patients before and after SGB, and inform the design and sample size calculation of a future definitive RCT.
Participants will be pDoC patients with intact skulls after acquired brain injury who will undergo spinal cord electronic stimulator implantation under general anesthesia at Beijing Tiantan Hospital. Stellate ganglion block will be administrated before the surgery. Polysomnography, total sleep time, cerebral oxygen saturation, cerebral hemodynamic parameters, CRS-R scores will be investigated.
- Being tested
- stellate ganglion block with 0.5% ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stellate ganglion block with 0.5% ropivacaineDrug
A single dose of ultrasound-guided stellate ganglion block with 0.5% ropivacaine was administered to the pDoC patients after induction of general anesthesia but before surgical incision.
| Study group | Role | What they receive |
|---|---|---|
| stellate ganglion block | Experimental | preoperative administration of stellate ganglion block Receives: Drug: stellate ganglion block with 0.5% ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in total sleep time
total sleep time on PSG
Measured: from the baseline night (the night before surgery) to the night of surgery (postoperative night 1)
Secondary outcomes (13)
sleep structure before and after SGB
sleep structure will be measured using polysomnography (PSG)
Measured: from the baseline night (the night before surgery) to the night of surgery (postoperative night 1)
sleep latencies before and after SGB
sleep latencies will be measured using polysomnography (PSG)
Measured: from the baseline night (the night before surgery) to the night of surgery (postoperative night 1)
sleep stage distribution before and after SGB
sleep stage distribution will be measured using polysomnography (PSG)
Measured: from the baseline night (the night before surgery) to the night of surgery (postoperative night 1)
Change in cerebral oxygen saturation
Regional cerebral oxygen saturation (rSO₂) measured by near-infrared spectroscopy (NIRS).
Measured: 30 minutes after stellate ganglion block
Change in cerebral hemodynamic parameters
cerebral hemodynamic parameters measured by Transcranial Doppler（TCD）
Measured: 30 minutes after stellate ganglion block.
the recovery of consciousness
Consciousness recovery will be assessed using the Coma Recovery Scale-Revised (CRS-R). It assesses patients across six functional domains: auditory, visual, motor, oromotor/verbal, communication, and arousal. The total score ranges from 0 to 23, with higher scores indicating a higher level of consciousness.
Measured: 1 and 30 days postoperatively
Length of ICU stay
Measured: 30 days postoperatively
Costs of ICU stay
Measured: 30 days postoperatively
Safety outcomes
SGB-related complications and unanticipated adverse events
Measured: 30 days postoperatively
Feasibility outcomes
Measured: 30 days postoperatively
SGB success rate
Measured: 30 days postoperatively
PSG data completeness
Measured: 30 days postoperatively
adverse event rate
Measured: 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study startOct 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stellate Ganglion BlockStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruquan Han, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07274683
- Sponsor's protocol ID
- LJH20250928
- Status last verified
- Dec 2025
- First submitted
- 15 Nov 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data generated or analysed during this study will be included in published article. The data that support the findings of this study are available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Stellate Ganglion Block on Postoperative Sleep Status in Patients With Prolonged Disorders of Consciousness
- ClinicalTrials.gov ID
- NCT07274683
- Acronym / sponsor ID
- LJH20250928
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Dec 2025 (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 is a prospective, single-centre, single-arm, self-controlled, exploratory pilot study.
The goal of this clinical trial is to learn about the effect of preoperative administration of stellate ganglion block on postoperative sleep status in patients with prolonged disorders of consciousness. The main aims to answer are: To explore the feasibility and safety of unilateral SGB in pDOC patients, evaluate its impact on sleep time and sleep architecture from the preoperative night to the night of surgery, compare the cerebral hemodynamic parameters, cerebral oxygen saturation and Coma Recovery Scale-Revised (CRS-R) scores in pDOC patients before and after SGB, and inform the design and sample size calculation of a future definitive RCT.
Participants will be pDoC patients with intact skulls after acquired brain injury who will undergo spinal cord electronic stimulator implantation under general anesthesia at Beijing Tiantan Hospital. Stellate ganglion block will be administrated before the surgery. Polysomnography, total sleep time, cerebral oxygen saturation, cerebral hemodynamic parameters, CRS-R scores will be investigated.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stellate ganglion block | Experimental | Drug: stellate ganglion block with 0.5% ropivacainepreoperative administration of stellate ganglion block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18-65 years;
- Prolonged disorders of consciousness after acquired brain injury;
- Scheduled to undergo spinal cord electronic stimulator implantation under general anesthesia;
- The skull is intact;
- Informed consent is obtained;
Key exclusion criteria (11 listed)
- Continuous sedation therapy is performed within 72 hours prior to the study;
- The integrity of brain structure is disrupted due to causes such as open head injury and cerebral parenchymal resection;
- Decreased intracranial compliance caused by hydrocephalus and other reasons;
- Airway stenosis or severe dysfunction of ventilation or gas exchange due to various causes;
- Known or suspected severe cardiac, pulmonary, and renal dysfunction;
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 |
|---|---|---|
| stellate ganglion block with 0.5% ropivacaineA single dose of ultrasound-guided stellate ganglion block with 0.5% ropivacaine was administered to the pDoC patients after induction of general anesthesia but before surgical incision. | Drug | stellate ganglion block |
Primary outcome
The change in total sleep time
Time frame: from the baseline night (the night before surgery) to the night of surgery (postoperative night 1)
total sleep time on PSG
13 secondary outcomes
sleep structure before and after SGB
Time frame: from the baseline night (the night before surgery) to the night of surgery (postoperative night 1)
sleep latencies before and after SGB
Time frame: from the baseline night (the night before surgery) to the night of surgery (postoperative night 1)
sleep stage distribution before and after SGB
Time frame: from the baseline night (the night before surgery) to the night of surgery (postoperative night 1)
Change in cerebral oxygen saturation
Time frame: 30 minutes after stellate ganglion block
Change in cerebral hemodynamic parameters
Time frame: 30 minutes after stellate ganglion block.
the recovery of consciousness
Time frame: 1 and 30 days postoperatively
Length of ICU stay
Time frame: 30 days postoperatively
Costs of ICU stay
Time frame: 30 days postoperatively
Safety outcomes
Time frame: 30 days postoperatively
Feasibility outcomes
Time frame: 30 days postoperatively
SGB success rate
Time frame: 30 days postoperatively
PSG data completeness
Time frame: 30 days postoperatively
adverse event rate
Time frame: 30 days postoperatively
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 27 Oct 2026.
- Individual participant dataSharing planned: Yes. All data generated or analysed during this study will be included in published article. The data that support the findings of this study are available from the corresponding author upon reasonable request.
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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 stellate ganglion block with 0.5% ropivacaine in people with Stellate Ganglion Block and Prolonged Disorders of Consciousness, run by Beijing Tiantan 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 5 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: opening soon, as of the sponsor's last update on 27 Oct 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 Minyu Jian (+8613522550438, yum1988@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in total sleep time (time frame: from the baseline night (the night before surgery) to the night of surgery (postoperative night 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2026.