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NCT07274683
Stellate Ganglion Block on Postoperative Sleep Status in Patients With Prolonged Disorders of Consciousness
Conditions: Stellate Ganglion Block, Prolonged Disorders of Consciousness, Sleep
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 25
Sponsor: Beijing Tiantan Hospital
Location: Beijing Tian Tan Hospital Beijing
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. 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.
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;
* Pregnant or lactating women
Source: ClinicalTrials.gov (NCT07274683). StuddyBuddy aggregates publicly available trial information.