the 95% Effective Dose of Ciprofol for Adjunctive Sedation Undergoing Knee Arthroplasty in Elderly People
A Biased Coin Design Sequential Method for Determining the 95% Effective Dose of Ciprofol for Adjunctive Sedation Undergoing Knee Arthroplasty in Elderly People
1 other identifier
interventional
70
1 country
1
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 95% effective dose of ciprofol-assisted sedation in elderly patients undergoing spinal anesthesia using a biased coin design up-and-down sequential method(BCD-UDM)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Nov 2023
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 29, 2023
CompletedFirst Submitted
Initial submission to the registry
January 23, 2024
CompletedFirst Posted
Study publicly available on registry
March 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedMarch 5, 2024
February 1, 2024
5 months
January 23, 2024
February 27, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Modified Alertness Sedation Score (MOAA/S)
Changes in Modified Alertness Sedation Score
24 hours
Bispectral index (BIS)
Changes in Bispectral index
24 hours
Secondary Outcomes (4)
systolic blood pressure （SBP）
24 hours
diastolic blood pressure（DBP）
24 hours
heart rate (HR)
24 hours
pulse oxygen saturation（SpO2）
24 hours
Other Outcomes (1)
Occurrence of Sedation-related adverse events
72 hours
Study Arms (1)
ciprofol-assisted sedation 1
EXPERIMENTALAdjusting the dose of ciprofol-assisted sedation in knee arthroplasty on a case-by-case basis
Interventions
Ciprofol was injected intravenously, and was pumped during operation to maintain sedation
Eligibility Criteria
You may qualify if:
- Age ≥ 65 years
- ASA grade I\~III
- BMI 18\~28 kg/m2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 23, 2024
First Posted
March 5, 2024
Study Start
November 29, 2023
Primary Completion
May 1, 2024
Study Completion
May 1, 2024
Last Updated
March 5, 2024
Record last verified: 2024-02