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
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)
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 ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03399019 -
Bispectral Index(BIS) on Depth of Sedation With Dexmedetomidine, Propofol and Midazolam During Spinal Anesthesia
|
N/A | |
| Completed |
NCT03220880 -
Intranasal Dexmedetomidine Sedation in Children for Non-painful Procedures
|
||
| Recruiting |
NCT04820205 -
Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Procedural Sedation in Children
|
N/A | |
| Recruiting |
NCT04549623 -
End-Tidal Carbon Dioxide Monitoring Device for Sedation During Endoscopic Ultrasonography
|
N/A | |
| Recruiting |
NCT04822064 -
Comparison of Oral Chloral Hydrate and Combination of Intranasal Dexmedetomidine and Ketamine for Rescue After Failed Pediatric Procedural Sedation
|
N/A | |
| Completed |
NCT01001533 -
Assess the Ability of Electrical Cardiometry to Trend Hemodynamic Variables During Dexmedetomidine Sedation
|
N/A | |
| Completed |
NCT01527903 -
A Comparison Between Propofol-Remifentanil and Midazolam-Remifentanil Sedation in the Intensive Care Unit
|
Phase 4 | |
| Completed |
NCT00747721 -
Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU
|
Phase 1 | |
| Completed |
NCT00158873 -
Pharmaco-Economic Study Of Ultiva In Intensive Care Unit(ICU)Subjects
|
Phase 4 | |
| Terminated |
NCT00205517 -
Sedation and Psychopharmacology in Critical Care
|
N/A | |
| Recruiting |
NCT04096768 -
The Use of Ketamine and Dexmedetomidine in Intensive Care Sedation
|
Phase 3 | |
| Active, not recruiting |
NCT05082623 -
The Effect of Music on Delirium, Pain, Need of Sedation, Anxiety and Vital Parameters
|
N/A | |
| Suspended |
NCT03285165 -
Cerebral Vascular Effects of Dexmedetomidine Versus Propofol Sedation in Intubated Mechanically Ventilated ICU Patients
|
Phase 2/Phase 3 | |
| Active, not recruiting |
NCT04788589 -
Sedation and Ventilator Weaning Protocol in PICU
|
N/A | |
| Completed |
NCT03425474 -
Study of Remimazolam Tosilate in Patients Undergoing Diagnostic Upper GI Endoscopy
|
Phase 3 | |
| Recruiting |
NCT06061159 -
The ED95 of Single Intravenous Bolus Remimazolam Besylate in Pediatric Patients During General Anesthesia Induction
|
Phase 4 | |
| Completed |
NCT06449365 -
Comparison of Intravenous V/S Nasal Atomizer Delivery of Midazolam for Conscious Sedation for No-scalpel Vasectomy
|
Phase 4 | |
| Completed |
NCT02171910 -
Doxapram as an Additive to Propofol Sedation in Sedation for ERCP
|
Phase 4 | |
| Completed |
NCT02211118 -
Sedation and Physiological Effects of Intranasal Dexmedetomidine in Severe COPD
|
Phase 4 | |
| Completed |
NCT01694745 -
EUROpean Pain Audit In Neonates
|
N/A |