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Effects of remimazolam combined with propofol for maintenance of anesthesia on the quality of recovery and postoperative sleep in elderly patients undergoing laparoscopic surgery

Effects of remimazolam combined with propofol for maintenance of anesthesia on the quality of recovery and postoperative sleep in elderly patients undergoing laparoscopic surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083436
Enrollment
Unknown
Registered
2024-04-25
Start date
2024-05-01
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

None

Interventions

Propofol Group:Continuous intravenous infusion of propofol 4-12mg · kg-1 · h-1 and remifentanil 0.2-0.3 µg · kg-1 · min-1 for intraoperative anesthesia maintenance
Propofol-remimazolam Group:Continuous intravenous infusion of remimazolam 0.3mg · kg-1 · h-1+propofol 2-4mg · kg-1 · h-1 and remifentanil 0.2-0.3 µg · kg-1 · min-1 for intraoperative anesthesia mainte

Sponsors

Anesthesiology Department of Shanghai Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patient informed consent; Plan to undergo laparoscopic surgery on a scheduled date; Expected surgical duration = 1 hour; American Society of Anesthesiologists (ASA classification) grades I-III; 65 years old<age<80 years old; Body mass index (BMI) 18-28kg/m2

Exclusion criteria

Exclusion criteria: Severe heart disease (NYHA heart function grading>level 3), severe renal insufficiency (blood creatinine>1.8mg/dL (159.1) µmol/L or receiving renal replacement therapy, severe liver dysfunction (modified Child Pugh grading to C grade); Individuals with a history of allergies to the anesthetic drugs involved in this study are known; Preoperative sleep disorders with a Pittsburgh sleep quality index (PSQI) score of = 7; Individuals who rely on sedatives, antidepressants, and alcoholics; Having mental illness or cognitive impairment, inability to cooperate and poor compliance; Patients with other contraindications to anesthesia or surgery; Refusing to sign informed consent form; Participated in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Awakening time;

Secondary

MeasureTime frame
Postoperative PSQI score;Hemodynamic indicators during anesthesia;MOAA/S score during awakening period;Richmond Agitation and Sedation Scale during awakening period;VAS score at postoperative time points;

Countries

China

Contacts

Public ContactLulong Bo

Shanghai Changhai Hospital

nbastars@126.com+86 138 1728 3189

Outcome results

None listed

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