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NCT Number: NCT06293131

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

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

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ciprofol

Drug

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

Other names: Ropivacaine

Primary outcomes

  1. Modified Alertness Sedation Score (MOAA/S)

    Time frame: 24 hours

    Changes in Modified Alertness Sedation Score

  2. Bispectral index (BIS)

    Time frame: 24 hours

    Changes in Bispectral index

Secondary outcomes

  1. systolic blood pressure (SBP)

    Time frame: 24 hours

    Changes in systolic blood pressure

  2. diastolic blood pressure(DBP)

    Time frame: 24 hours

    Changes in diastolic blood pressure

  3. heart rate (HR)

    Time frame: 24 hours

    changes in heart rate

  4. pulse oxygen saturation(SpO2)

    Time frame: 24 hours

    changes in pulse oxygen saturation

Other outcomes

  1. Occurrence of Sedation-related adverse events

    Time frame: 72 hours

    It includes intraoperative and postoperative sedation-related adverse events

Sponsors and collaborators

Lead sponsor

Second Hospital of Shanxi Medical University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 5, 2024
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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