Comparative Evaluation of Dexmedetomidine and Remazolam on Postoperative Sleep Quality in Elderly Patients Undergoing Percutaneous transforaminal endoscopic lumbar discectomy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400091576

Enrollment

Unknown

Registered

2024-10-30

Start date

2024-11-01

Completion date

Unknown

Last updated

2024-11-18

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

Conditions

Postoperative sleep disturbances

Interventions

Remazolam group:3 minutes before the start of surgery, remazolam 0.1mg / kg was injected intravenously as the loading dose, followed by a maintaince dose of 0.3mg / kg / h. An intravenous target-contr

Dexmedetomidine group:20 minutes before the start of surgery, dexmedetomidine 0.5 ug/kg was injected intravenously pumped for 10 minutes as the loading dose, followed by a maintaince dose of 0.5ug / k

Eligibility

Sex/Gender

All

Age

60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Surgical procedure: Percutaneous transforaminal endoscopic lumbar discectomy under conscious sedation + local anesthesia 2. Age = 60 years old 3. ASA I-III 4. The patient and their family understand and voluntarily sign the informed consent form: Percutaneous transforaminal endoscopic lumbar discectomy under conscious sedation + local anesthesia

Exclusion criteria

Exclusion criteria: 1. Patients with a history of mental illness or a sleep disorder under treatment; 2. Patients with a basic heart rate lower than 60 beats / minute; 3. Patients allergic to one of the drugs of dexmedetomidine, remazolam, remifentanil, or lidocaine; 4. Patients with severe hypertension and uncontrolled diseases such as hypertension, diabetes, arrhythmia, myocardial infarction and cerebral infarction; 5. Patients with severe liver and kidney dysfunction; 6. Patients with a history of alcohol addiction or drug abuse; 7. Patients who refuse to sign the informed consent form; 8 Patients who were unable to communicate before surgery and were tested for noncompliance.

Design outcomes

Primary

Measure	Time frame
Pittsburgh Sleep Quality Index, PSQI;	—

Secondary

Measure	Time frame
Mean arterial pressure, heart rate, blood oxygen saturation, and respiratory rate;Visual analogue scale, VAS;Ramsay scale;	—

Countries

China

Contacts

Public ContactHe Zhongxian

Affiliated Panyu Central Hospital, Guangzhou Medical University

61305566@qq.com+86 137 5184 5410

Outcome results

None listed

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