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

NCT ID: NCT07274683

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-01-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

stellate ganglion block

preoperative administration of stellate ganglion block

stellate ganglion block with 0.5% ropivacaine

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ruquan Han

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Tian Tan Hospital

Beijing, , China

Countries

China

Central Contacts

Minyu Jian

Role: CONTACT

yum1988@163.com

+8613522550438

Other Identifiers

LJH20250928

Identifier Type: -

Identifier Source: org_study_id