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Clinical Trials/NCT06293131
NCT06293131
Completed
Early Phase 1

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

Second Hospital of Shanxi Medical University1 site in 1 country70 target enrollmentStarted: May 29, 2023Last updated:

Overview

Phase
Early Phase 1
Status
Completed
Sponsor
Second Hospital of Shanxi Medical University
Enrollment
70
Locations
1
Primary Endpoint
Modified Alertness Sedation Score (MOAA/S)

Overview

Brief Summary

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

Detailed 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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Sequential
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

ciprofol-assisted sedation 1

Experimental

Adjusting the dose of ciprofol-assisted sedation in knee arthroplasty on a case-by-case basis

Intervention: Ciprofol (Drug)

Outcomes

Primary Outcomes

Modified Alertness Sedation Score (MOAA/S)

Time Frame: 24 hours

Changes in Modified Alertness Sedation Score

Bispectral index (BIS)

Time Frame: 24 hours

Changes in Bispectral index

Secondary Outcomes

  • systolic blood pressure (SBP)(24 hours)
  • diastolic blood pressure(DBP)(24 hours)
  • heart rate (HR)(24 hours)
  • pulse oxygen saturation(SpO2)(24 hours)

Investigators

Sponsor
Second Hospital of Shanxi Medical University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Zheng Guo

Professor

Second Hospital of Shanxi Medical University

Study Sites (1)

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