Sedation Clinical Trial
Official title:
A Biased Coin Design Sequential Method for Determining the 95% Effective Dose of Ciprofol for Adjunctive Sedation Undergoing Knee Arthroplasty in Elderly People
Verified date | February 2024 |
Source | Second Hospital of Shanxi Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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)
Status | Recruiting |
Enrollment | 70 |
Est. completion date | May 2024 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - Age = 65 years - ASA grade I~III - BMI 18~28 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 |
Country | Name | City | State |
---|---|---|---|
China | Second Hospital of Shanxi Medical University | Taiyuan | Shanxi |
Lead Sponsor | Collaborator |
---|---|
Second Hospital of Shanxi Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Occurrence of Sedation-related adverse events | It includes intraoperative and postoperative sedation-related adverse events | 72 hours | |
Primary | Modified Alertness Sedation Score (MOAA/S) | Changes in Modified Alertness Sedation Score | 24 hours | |
Primary | Bispectral index (BIS) | Changes in Bispectral index | 24 hours | |
Secondary | systolic blood pressure (SBP) | Changes in systolic blood pressure | 24 hours | |
Secondary | diastolic blood pressure(DBP) | Changes in diastolic blood pressure | 24 hours | |
Secondary | heart rate (HR) | changes in heart rate | 24 hours | |
Secondary | pulse oxygen saturation(SpO2) | changes in pulse oxygen saturation | 24 hours |
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