Stellate Ganglion Block on Postoperative Sleep Status in Patients With Prolonged Disorders of Consciousness
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorBeijing Tiantan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial population
pDOC Patients from Beijing Tian Tan Hospital
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
stellate ganglion block with 0.5% ropivacaine
DrugA 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.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: stellate ganglion block1 intervention
Trial outcomes
Primary outcomes
1
Total sleep time
total sleep time on PSG
Time frame
on the first postoperative nightSecondary outcomes
1
cerebral oxygen saturation
Regional cerebral oxygen saturation (rSO₂) measured by near-infrared spectroscopy (NIRS).
Time frame
30 minutes after stellate ganglion block2
cerebral hemodynamic parameters
cerebral hemodynamic parameters measured by Transcranial Doppler（TCD）
Time frame
30 minutes after stellate ganglion block.3
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.
Time frame
1 and 30 days postoperatively4
Length of ICU stay
Time frame
30 days postoperativelySponsors and contacts
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Source ClinicalTrials.gov
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