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This protocol is a clinical study of fospropofol disodium for general anesthesia in adults undergoing laparoscope-assisted abdominal surgery. The study has three main objectives: First, to explore the use of propofol disodium as the lowest effective dose for induction of general anesthesia; Secondly, to evaluate the efficacy and safety of fospropofol disodium in the maintenance phase of general anesthesia, and to determine its effective dose range; Finally, the effects of fospropofol disodium on Bispectral Index during induction, maintenance and recovery were studied, and compared with propofol to understand its characteristic changes. The randomized, single-blind, controlled design of the study, with an expected enrollment of 373 patients, was designed to achieve its objectives through a three-phase trial design to provide important clinical information about the safety and efficacy of the use of propofol disodium.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fospropofol group | Experimental | patients in the fospropofol group received propofol phosphate, sufentanil, and rocuronium. |
|
| Propofol group | Active Comparator | patients in the propofol group received propofol, sufentanil, and rocuronium. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fospropofol | Drug | Use fospropofol for general anesthesia maintenance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of perioperative hypotension | Incidence of hypotension throughout perioperative period | From the beginning to the end of surgery |
| Incidence of injection pain | Incidence of perceived injection pain during anesthesia induction | During induction of anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Glomerular filtration rate | The patients' glomerular filtration rate | First day after surgery |
| Eeg dual frequency exponential waveform | Eeg dual frequency index waveform during operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tao Hong, Master | Contact | 15927008056 | whutthong@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Tao Hong, Master | Tongji Hospital, Tongji Medical College, Huazhong University of Scien | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Recruiting | Wuhan | Hubei | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29992157 | Background | Dinis-Oliveira RJ. Metabolic Profiles of Propofol and Fospropofol: Clinical and Forensic Interpretative Aspects. Biomed Res Int. 2018 May 24;2018:6852857. doi: 10.1155/2018/6852857. eCollection 2018. | |
| 22584560 | Result | Patwardhan A, Edelmayer R, Annabi E, Price T, Malan P, Dussor G. Receptor specificity defines algogenic properties of propofol and fospropofol. Anesth Analg. 2012 Oct;115(4):837-40. doi: 10.1213/ANE.0b013e318258b9db. Epub 2012 May 14. |
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| ID | Term |
|---|---|
| C472965 | fospropofol |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Propofol | Drug | Use propofol for general anesthesia maintenance |
|
|
| From the beginning to the end of surgery |
| Urea nitrogen | Blood level of urea nitrogen | First day after surgery |
| Creatinine | Blood level of creatinine | First day after surgery |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |