Median Effective Dose of Ciprofol-Assisted Sedation for Elderly Patients Undergoing Knee Arthroplasty

Shanxi Medical University

Status and phase

Completed

Early Phase 1

Conditions

Knee Arthroplasty

Sedation

ED50

Treatments

Drug: Ciprofol

Study type

Interventional

Funder types

Other

Identifiers

NCT06293131

yuewei20230705

Details and patient eligibility

About

Regional anesthesia is a common clinical anesthesia method, and regional anesthesia-assisted sedation play a central role in promoting patient comfort and relieving anxiety. With increasing age, elderly people experience changes in pharmacokinetics and pharmacodynamics and increased drug sensitivity. Ciprofol has advantages in adverse events such as hypotension and respiratory depression. There are fewer studies on the recommended dosage of ciprofol-assisted sedation for intrathecal anesthesia in elderly patients. The aim of study is to identify the median effective dose(ED50) of ciprofol-assisted sedation in elderly patients undergoing spinal anesthesia

Full description

Select the patients who received knee arthroplasty in the Second Hospital of Shanxi Medical University. The patients received a loading dosage of 0.05mg/kg of ciprofol to begin sedation following the completion of intravertebral anesthesia, and the maintenance dose is calculated using the sequential method. Based on the relevant literature and pilot study, 0.2 mg·kg-1·h-1 is selected as initial test dose with a dose gradient of 0.02 mg·kg-1·h-1. The Modified Alertness Sedation Score (MOAA/S ) scores and the bispectral index (BIS) were recorded for patients before administration (T0), 5 min after administration (T1), 10 min after administration (T2), 20 min after administration (T3), 30 min after administration (T4), 45 min after administration (T5), and 60min after administration (T6). If the first patient had ≥ 4 time points with MOAA/A score ≤3 and BIS<85 from T0-T6, the sedation was regarded as satisfactory, then the next patient 's dose of ciprofol was reduced by one level. On the contrary, if the patient's MOAA/S score and BIS at T0-T6 had less than 4 points of MOAA/S ≤3 points and BIS <85, it was regarded as unsatisfactory sedation. The next patient's dose of ciprofol was increased by one level. After 8 crossovers, the trial was terminated. At the same time, the change of vital signs and adverse reactions before and after administration were recorded

Enrollment

70 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥ 65 years
ASA grade I~III
BMI 18~30 kg/m2

Exclusion criteria

Contraindications to intrathecal anesthesia
Suffering from severe psychiatric or neurologic disorders or taking sedative drugs within the last 3 months
Difficult airway or having respiratory diseases such as upper airway obstruction
Severe cardiovascular system diseases
Severe hepatic or renal dysfunction
Allergy or contraindication to propofol and its drug-related components
Patient Prefusal