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

NCT07274683 | Not Yet Recruiting DMC

• 1 other identifier: LJH20250928
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Stellate Ganglion Block; Prolonged Disorders of Consciousness; Sleep

Outcome Measures

Primary Outcomes (1)

• Total sleep time

  total sleep time on PSG

  on the first postoperative night

Secondary Outcomes (5)

• 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

• Length of ICU stay

  30 days postoperatively

• Costs of ICU stay

  30 days postoperatively

Study Arms (1)

stellate ganglion block

preoperative administration of stellate ganglion block

Drug: stellate ganglion block with 0.5% ropivacaine

Interventions

stellate ganglion block with 0.5% ropivacaine DRUG

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.

stellate ganglion block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

pDOC Patients from Beijing Tian Tan Hospital

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tian Tan Hospital

Beijing, 100070, China

Location

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Minyu Jian

CONTACT

+8613522550438; yum1988@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: December 10, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Access Criteria: The data that support the findings of this study are available from the corresponding author upon reasonable request.

Locations

CN (1)