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

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)

Study Overview

• Status: Recruiting
• Conditions: Knee Arthroplasty; Sedation; ED95
• Intervention / Treatment: Drug: Ciprofol

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Shanxi
    • Taiyuan, Shanxi, China, 030001
      • Recruiting
      • Second Hospital of Shanxi Medical University
      • Contact: Zheng Guo, M.B.,Ph.D.; Phone Number: +863513365790; Email: guozheng713@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ciprofol-assisted sedation 1; Adjusting the dose of ciprofol-assisted sedation in knee arthroplasty on a case-by-case basis	Drug: Ciprofol; Ciprofol was injected intravenously, and was pumped during operation to maintain sedation; Other Names: Ropivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Alertness Sedation Score (MOAA/S)	Changes in Modified Alertness Sedation Score	24 hours
Bispectral index (BIS)	Changes in Bispectral index	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
systolic blood pressure （SBP）	Changes in systolic blood pressure	24 hours
diastolic blood pressure（DBP）	Changes in diastolic blood pressure	24 hours
heart rate (HR)	changes in heart rate	24 hours
pulse oxygen saturation（SpO2）	changes in pulse oxygen saturation	24 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of Sedation-related adverse events	It includes intraoperative and postoperative sedation-related adverse events	72 hours

Collaborators and Investigators

• Sponsor: Second Hospital of Shanxi Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Estimated): March 5, 2024

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: yuewei20231129

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No