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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06293144
Other study ID # yuewei20231129
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date November 29, 2023
Est. completion date May 2024

Study information

Verified date February 2024
Source Second Hospital of Shanxi Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Description:

Select the patients who will receive knee arthroplasty in the Second Hospital of Shanxi Medical University. The patients will receive 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 a biased coin design up-and-down 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 from T0-T6, the sedation was regarded as satisfactory, the dose of next patient is randomly assigned to the next lower dose with 5% probability, or to the same dose with 95% probability; If the previous patient was not satisfactorily sedated, the next patient's infusion dose was increased by 0.02 mg·kg-1·h-1. When the number of satisfied cases of sedation reaches 45, the trial is terminated. At the same time, the change of vital signs and adverse reactions before and after administration were recorded


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ciprofol
Ciprofol was injected intravenously, and was pumped during operation to maintain sedation

Locations

Country Name City State
China Second Hospital of Shanxi Medical University Taiyuan Shanxi

Sponsors (1)

Lead Sponsor Collaborator
Second Hospital of Shanxi Medical University

Country where clinical trial is conducted

China, 

Outcome

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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