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Clinical observation of subanesthetic dose esketamine combined with dexmedetomidine in PELD

Clinical observation of subanesthetic dose esketamine combined with dexmedetomidine in PELD

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086226
Enrollment
Unknown
Registered
2024-06-27
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Degenerative lesions of the lumbar spine

Interventions

Esketamine Group (S Group):? After the surgical position was placed, the loading dose of dexmedetomidine was injected immediately (0.5µg/kg, 10 minutes)
Esketamine was also pumped at 0.02mg/kg/h ? After disinfection, sufentanil was given 0.05µg/kg
Control group (Group D):? After the surgical position was placed, the loading dose of dexmedetomidine was injected immediately (0.5µg/kg, 10 minutes)
At the same time, 0.02ml/kg/h pump was injected with equal volume of normal saline ? After disinfection, sufentanil was given 0.05µg/kg.

Sponsors

he Second Hospital of Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years old, male or female, ASA grade I-III; 2. Patients with single level lumbar disc herniation, lumbar disc disease and other patients requiring PELD surgery; 3. Intravenous anesthesia is planned; 4. Voluntarily participate in the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients refused to participate in the study 2. Bmi higher than 30, 3. Obstructive sleep apnea syndrome or STOP-Bang score was 3 4. Preoperative Pittsburgh Sleep Quality Index (PSQI) was higher than 7 5. Drug allergies 6. Stroke and multiple trauma within 6 months before surgery 7. Use of psychotropic substances, night shift, reluctance to participate in research, or unexpected discharge 8. Preoperative delirium, Parkinson's disease, dementia, communication difficulties, severe hearing or vision impairment 9. Congenital heart disease or other serious cardiovascular disease above NYHA level III

Design outcomes

Primary

MeasureTime frame
Intraoperative moderate to severe pain rate;Macnab score of lumbar function;Drug-related adverse events;Use of vasoactive drugs;

Secondary

MeasureTime frame
vital signs;hospital stays;Health status SF-36 score;Incidence of PSD ;vas score;Postoperative anxiety and depression scores;ODI score for low back pain;24 h after surgery patients and surgeons satisfaction of anesthesia;

Countries

China

Contacts

Public ContactJin Yanwu

The Second Hospital of Shandong University

jinyanwu_aa@163.com+86 176 6008 5535

Outcome results

None listed

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