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Remimazolam, a novel ultra-short acting benzodiazepine that combined the advantages of midazolam and remifentanil, has been developed for procedural sedation, induction and maintenance of general anesthesia, and sedation in the ICU. Previous studies have suggested that efficacy and safety of remimazolam are not inferior to propofol or midazolam in patients undergoing colonoscopy,bronchoscopy and some other treatments. However, the efficacy and potential adverse effects of remimazolam on patients undergoing endovascular procedures of cerebrovascular disorders is still unclear. In this study, we tend to conduct a single-center, randomized, single-blind ,non-inferiority trial to compare the efficacy and safety of remimazolam and propofol in endovascular procedures of cerebrovascular disorders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remimazolam | Experimental | In remimazolam group, a 0.1 mg/kg dose of intravenous remimazolam was administered for induction, and 0.3-0.7 mg/kg/h infusion for maintenance after intubation. |
|
| Propofol | Active Comparator | In propofol group, a 2 mg/kg dose of intravenous propofol was administered for induction, and 4-12 mg/kg/h infusion for maintenance after intubation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| remimazolam | Drug | Remimazolam will be administered during induction and maintenance for general anesthesia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| time to open eye | from the stop of trial drugs to open eye to verbal command, at an average of 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| time to loss of consciousness | from initial administration of trial drugs to loss of response to verbal command, at an average of 5 minutes | |
| time to recovery of spontaneous breathing | from end of giving trial drugs to recovery of spontaneous breathing ,at an average of 20 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing hospital | Xi'an | Shaanxi | 710032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32530890 | Result | Sneyd JR, Rigby-Jones AE. Remimazolam for anaesthesia or sedation. Curr Opin Anaesthesiol. 2020 Aug;33(4):506-511. doi: 10.1097/ACO.0000000000000877. | |
| 32274703 | Result | Keam SJ. Remimazolam: First Approval. Drugs. 2020 Apr;80(6):625-633. doi: 10.1007/s40265-020-01299-8. |
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individual data including protocol and statistical analysis plan will be shared during 3 months and 5 years following article publication after deidentification
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| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C522201 | remimazolam |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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Randomization is done by an investigator who is not involved in anesthesia and outcome assessment. Participants are unaware of the group allocation. Due to the different color of remimazolam and propofol, the care provider is not blinded to the group allocation. At the end of the surgery, anesthetics are removed before outcome assessment. And the outcome assessor is blinded to the grouping.
| propofol | Drug | Propofol will be administered during induction and maintenance for general anesthesia. |
|
| time to endotracheal tube extubation | from end of giving trial drugs to removing endotracheal tube ,at an average of 25 minutes |
| time to orientation | from end of giving trial drugs to recovery of orientation to name, location or date ,at an average of 30 minutes |
| the dosages of vasoactive drugs during surgery | from initial administration of trial drugs to end of surgery, at an average of 3 hours |
| Number of episodes of hypotension during surgery | Hypotension is defined as decrease of mean arterial pressure more than 20% of the baseline, persisting longer than 1 minute | from initial administration of trial drugs to end of surgery, at an average of 3 hours |
| Number of episodes of hypertension during surgery | Hypertension is defined as increase of mean arterial pressure more than 20% of the baseline, persisting longer than 1 minute | from initial administration of trial drugs to end of surgery, at an average of 3 hours |
| the level of lactic acid of arterial blood | at the end of the surgery |
| The highest Richmond Agitation and Sedation Score during emergence | from end of the surgery to 30 minutes after extubation, approximately 50 minutes |
| Renkin's Score at 30 days and three months after surgery | 30 days and three months after surgery |
| Glasgow outcome Score at discharge | at discharge, approximately 3 days after surgery |
| length of postoperative ICU stay and hospital stay | from entering the ICU to leaving the ICU and from admission to discharge, approximately 3 days |
| the incidence of major complications during postoperative hospitalization | from the end of surgery to discharge, approximately 3 days |
| the incidence of delirium during emergence | from end of surgery to 30 minutes after extubation |
| the incidence of delirium within 3 days after surgery | from end of surgery to 3 days after surgery |
| the level of serum interleukin-6, tumor necrosis factor-α and S100β | at the end of the surgery |
| 30292760 | Result | Pastis NJ, Yarmus LB, Schippers F, Ostroff R, Chen A, Akulian J, Wahidi M, Shojaee S, Tanner NT, Callahan SP, Feldman G, Lorch DG Jr, Ndukwu I, Pritchett MA, Silvestri GA; PAION Investigators. Safety and Efficacy of Remimazolam Compared With Placebo and Midazolam for Moderate Sedation During Bronchoscopy. Chest. 2019 Jan;155(1):137-146. doi: 10.1016/j.chest.2018.09.015. Epub 2018 Oct 4. |
| D002318 | Cardiovascular Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |