- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06293131
Median Effective Dose of Ciprofol-Assisted Sedation for Elderly Patients Undergoing Knee Arthroplasty
February 27, 2024 updated by: Zheng Guo, Second Hospital of Shanxi Medical University
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
Study Overview
Detailed Description
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
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanxi
-
Taiyuan, Shanxi, China, 030001
- Second Hospital of Shanxi Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
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
|
Ciprofol was injected intravenously, and was pumped during operation to maintain sedation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Alertness Sedation Score (MOAA/S)
Time Frame: 24 hours
|
Changes in Modified Alertness Sedation Score
|
24 hours
|
Bispectral index (BIS)
Time Frame: 24 hours
|
Changes in Bispectral index
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
systolic blood pressure (SBP)
Time Frame: 24 hours
|
Changes in systolic blood pressure
|
24 hours
|
diastolic blood pressure(DBP)
Time Frame: 24 hours
|
Changes in diastolic blood pressure
|
24 hours
|
heart rate (HR)
Time Frame: 24 hours
|
changes in heart rate
|
24 hours
|
pulse oxygen saturation(SpO2)
Time Frame: 24 hours
|
changes in pulse oxygen saturation
|
24 hours
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurrence of Sedation-related adverse events
Time Frame: 72 hours
|
It includes intraoperative and postoperative sedation-related adverse events
|
72 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 29, 2023
Primary Completion (Actual)
September 28, 2023
Study Completion (Actual)
September 28, 2023
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
Other Study ID Numbers
- yuewei20230705
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Knee Arthroplasty
-
Smith & Nephew, Inc.Completed
-
University of AlbertaCompletedArthroplasty, Replacement, Knee | Knee Arthroplasty, TotalCanada
-
Rhode Island HospitalRecruitingArthroplasty, Replacement, Knee | Total Knee ArthroplastyUnited States
-
Limacorporate S.p.aRecruitingTotal Knee Arthroplasty | Revision Total Knee ArthroplastyUnited Kingdom, Portugal, Slovakia
-
Fondazione Don Carlo Gnocchi OnlusCompletedKnee Arthroplasty | Hip Arthroplasty
-
Smith & Nephew, Inc.RecruitingArthroplasty, Replacement, Knee | Unicompartmental Knee ArthroplastyUnited Kingdom
-
The University of Tennessee, KnoxvilleDePuy OrthopaedicsCompletedKnee Arthroplasty | Knee ProsthesisUnited States
-
Fondazione Don Carlo Gnocchi OnlusCompletedArthroplasty, Replacement, Knee | Arthroplasty, Replacement, HipItaly
-
DePuy OrthopaedicsJohnson & Johnson Health and Wellness Solutions, Inc.TerminatedTotal Knee Arthroplasty; Total Hip ArthroplastyUnited States
-
DePuy OrthopaedicsJohnson & Johnson Health and Wellness Solutions, Inc.TerminatedTotal Knee Arthroplasty; Total Hip ArthroplastyUnited States
Clinical Trials on Ciprofol
-
Zhejiang Cancer HospitalRecruiting
-
The Second Affiliated Hospital of Hainan Medical...RecruitingAdverse Effects | Intubation, IntratrachealChina
-
The Third People's Hospital of ChengduRecruiting
-
RenJi HospitalRecruitingGastric Cancer | Intestinal Polyps | Gastric Ulcer | Intestinal CancerChina
-
Capital Medical UniversityRecruitingMechanical Ventilation | Sedation and AnalgesiaChina
-
Nanfang Hospital, Southern Medical UniversityRecruitingSedation | Propofol | Low Blood Pressure | Norepinephrine | CiprofolChina
-
Le YuRecruiting
-
Sichuan Provincial People's HospitalActive, not recruiting
-
Sixth Affiliated Hospital, Sun Yat-sen UniversityNot yet recruitingElderly | Post Induction Hypotension
-
Haisco Pharmaceutical Group Co., Ltd.Completed