Menu
Not yet recruiting NCT07274683

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

Observational Stellate Ganglion Block Prolonged Disorders of Consciousness Sleep

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: stellate ganglion block with 0.5% ropivacaine.
Who it may be relevant to
Registry conditions: Stellate Ganglion Block, Prolonged Disorders of Consciousness, Sleep. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Drug stellate ganglion block with 0.5% ropivacaine
    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 outcome measures

  • Total sleep time [Time frame: on the first postoperative night]
Secondary outcome measures (5)
  • cerebral oxygen saturation [Time frame: 30 minutes after stellate ganglion block]
  • 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]

Eligibility criteria

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Beijing Tian Tan Hospital — Beijing

Identifiers

NCT: NCT07274683 · LJH20250928

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗