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NCT Number: NCT07274683

Stellate Ganglion Block on Postoperative Sleep Status in Patients With Prolonged Disorders of Consciousness

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 effect of preoperative administration of stellate ganglion block on postoperative polysomnography and total sleep time in patients with prolonged disorders of consciousness. • To explore the effect of preoperative administration of stellate ganglion block on postoperative cerebral oxygen saturation, cerebral hemodynamic parameters and recovery of consciousness. 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, GCS scores, WHIM scores and NCS scores will be investigated.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tian Tan Hospital

Beijing, 100070, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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;
  • Complicated by other mental or neurological disorders;
  • Local anesthetic allergy;
  • Other reasons for ineligibility in this study;
  • Informed consent is not obtained;

Treatment and study plan

stellate ganglion block with 0.5% ropivacaine

Drug

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.

Primary outcomes

  1. Total sleep time

    Time frame: on the first postoperative night

    total sleep time on PSG

Secondary outcomes

  1. cerebral oxygen saturation

    Time frame: 30 minutes after stellate ganglion block

    Regional cerebral oxygen saturation (rSO₂) measured by near-infrared spectroscopy (NIRS).

  2. cerebral hemodynamic parameters

    Time frame: 30 minutes after stellate ganglion block.

    cerebral hemodynamic parameters measured by Transcranial Doppler(TCD)

  3. the recovery of consciousness

    Time frame: 1 and 30 days postoperatively

    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.

  4. Length of ICU stay

    Time frame: 30 days postoperatively

  5. Costs of ICU stay

    Time frame: 30 days postoperatively

Study contacts

Contact information is provided by the study sponsor or research team.

Minyu Jian

CONTACT

[email protected]

+8613522550438

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

Effect of Stellate Ganglion Block on Postoperative Sleep Status in Patients With Prolonged Disorders of Consciousness: a Single--Centre Cohort Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Dec 10, 2025
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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