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

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

• Status: Not yet recruiting
• Conditions: Sleep; Stellate Ganglion Block; Prolonged Disorders of Consciousness
• Intervention / Treatment: Drug: stellate ganglion block with 0.5% ropivacaine

• Study Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

• Study Contact: Name: Minyu Jian; Phone Number: +8613522550438; Email: yum1988@163.com

Study Locations

• China
  • Beijing, China, 100070
    • Beijing Tian tan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

pDOC Patients from Beijing Tian Tan Hospital

Description

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;

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
stellate ganglion block; preoperative administration of stellate ganglion block	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total sleep time	total sleep time on PSG	on the first postoperative night

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cerebral oxygen saturation	Regional cerebral oxygen saturation (rSO₂) measured by near-infrared spectroscopy (NIRS).	30 minutes after stellate ganglion block
cerebral hemodynamic parameters	cerebral hemodynamic parameters measured by Transcranial Doppler（TCD）	30 minutes after stellate ganglion block.
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.	1 and 30 days postoperatively
Length of ICU stay		30 days postoperatively
Costs of ICU stay		30 days postoperatively

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: November 15, 2025
• First Submitted That Met QC Criteria: November 27, 2025
• First Posted (Actual): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Ropivacaine
• Other Study ID Numbers: LJH20250928

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data generated or analysed during this study will be included in published article. The data that support the findings of this study are available from the corresponding author upon reasonable request.
• IPD Sharing Access Criteria: The data that support the findings of this study are available from the corresponding author upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No