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To compare the effects of dexmedetomidine, low dose esketamine and combined stele ganglion block on postoperative sleep disorders in patients undergoing lumbar surgery

To compare the effects of dexmedetomidine, low dose esketamine and combined stele ganglion block on postoperative sleep disorders in patients undergoing lumbar surgery

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096811
Enrollment
Unknown
Registered
2025-02-07
Start date
2024-06-02
Completion date
Unknown
Last updated
2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative sleep disorders

Interventions

D:dextromet 0.5ug/kg/h was continuously pumped during surgery.
E:0.3 mg/kg/h of Echoclor was continuously pumped during the surgery.
SD: stellate ganglion block was performed at the level of the right 6th cervical vertebrae before surgery, and 5 ml of 0.25% ropivacaine was injected, and dextromet 0.5ug/kg/h was continuously pumped
SE:Before surgery, a stellate ganglion block was performed at the level of the right 6th cervical vertebrae, 5 ml of 0.25% ropivacaine was injected, and 0.3 mg/kg/h of Echoclor was continuously pumped
S:stellate ganglion block was performed at the level of the right 6th cervical vertebrae before surgery, and 5 ml of 0.25% ropivacaine was injected
C:A stellate ganglion block was performed at the level of the right 6th cervical vertebrae before the operation, 5 ml of saline was injected, and saline was continuously pumped during the operation.

Sponsors

Zhongda Hospital affiliated to Southeast University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Ages 18-75; Body Mass Index (BMI) between 18-30 kg/m^2; ASA Classification: I-III; 2.Voluntarily accept the treatment plan of this study.

Exclusion criteria

Exclusion criteria: 1.The Pittsburgh Sleep Quality Index (PSQI) score is greater than 7 before surgery. 2. History of allergy to ropivacaine, dexmedetomidine, esketamine; 3. patients with sick sinus syndrome, severe bradycardia (heart rate <50 beats/min) or second degree or higher atrioventricular conduction block, implantation of a permanent pacemaker, severe heart failure, or ejection fraction <30%; patients with severe hepatic and renal dysfunction (Child-Pugh grades B and C, CKD grades 3-5); and 4. patients with sleep apnea syndrome; those who need to use sleep aids before or after surgery; those who have serious complications after surgery: cerebral infarction, cerebral hemorrhage or heart failure, etc., patients who are planned to enter ICU after surgery and those who are not planned to enter ICU. 5. Patients with central nervous system diseases; patients with severe dementia, low cognitive function, speech impairment, severe hearing or visual impairment, mental disorder, coma, etc. who are unable to complete the assessment. 6. Patients who do not want to sign the informed consent.

Design outcomes

Primary

MeasureTime frame
Postoperative AIS Score on Day 1;

Secondary

MeasureTime frame
Sleep parameters 1,3 days after surgery;Postoperative pain scores on days 1 and 3;Use of analgesic pumps;postoperative adverse reaction;Incidence of postoperative sleep disorders;

Countries

China

Contacts

Public ContactRen Quan

Zhongda Hospital affiliated to Southeast University

g_quanren@163.com+86 139 5103 7047

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026