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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Primary outcome measure(s)

• The change in total sleep time — from the baseline night (the night before surgery) to the night of surgery (postoperative night 1)
  total sleep time on PSG

Trial sites (1)

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