Effect of Stellate Ganglion Block on Postoperative Sleep Status in Patients With Prolonged Disorders of Consciousness: a Single--Centre Cohort Study
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Beijing Tiantan Hospital
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Total sleep time
Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
Arms & Interventions
stellate ganglion block
preoperative administration of stellate ganglion block
Intervention: stellate ganglion block with 0.5% ropivacaine (Drug)
Outcomes
Primary Outcomes
Total sleep time
Time Frame: on the first postoperative night
total sleep time on PSG
Secondary Outcomes
- Length of ICU stay(30 days postoperatively)
- cerebral oxygen saturation(30 minutes after stellate ganglion block)
- cerebral hemodynamic parameters(30 minutes after stellate ganglion block.)
- the recovery of consciousness(1 and 30 days postoperatively)
- Costs of ICU stay(30 days postoperatively)
Investigators
Ruquan Han
Director
Beijing Tiantan Hospital