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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002398-68 | EudraCT Number | ||
| CURARI_2012 | Other Identifier | Comitato Etico dell'Azienda Ospedaliera di Padova |
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The purpose of this study is to determine the incidence of post-operative residual curarization in our patients and to determine if Cisatracurium and Rocuronium behave differently from each other in terms of residual curarization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cisatracurium | Experimental | Induction and maintaining of anaesthesia with Propofol. Analgesia either with Fentanyl or Fentanyl+Remifentanyl. Cisatracurium (Nimbex):
At the end of the surgical operation, patients will be administered Neostigmine 0.04 mg/kg and Atropine 0.02 mg/kg. Patients will be extubated with a TOF-Ratio of at least 0.90. |
|
| Rocuronium | Experimental | Induction and maintaining of anaesthesia with Propofol. Analgesia either with Fentanyl or Fentanyl+Remifentanyl Rocuronium (Esmeron):
At the end of the surgical operation, patients will be administered Neostigmine 0.04 mg/kg and Atropine 0.02 mg/kg. Patients will be extubated with a TOF-Ratio of at least 0.90. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisatracurium | Drug | Cisatracurium (Nimbex):
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of PORC | To determine the incidence of post-operative residual curarization in our operating rooms, comparing two different neuromuscular-blocking agents: Cisatracurium and Rocuronium. The primary endpoint is quantified with TOF-Ratio, determined with the device TOF-Watch SX (Organon, Netherlands). A TOF-Ratio<0.90 defines PORC. Three clinical parameters (head-tilt for 5 seconds, ability to swallow, presence of diplopia) are also evaluated. TOF-Ratios, as long as the above-mentioned clinical parameters are determined and evaluated at 15, 30 and 60 minutes after extubation of the patient. | Participants will be followed for the duration of their stay in the post-anaesthesia care unit (PACU), an expected average of 60 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of PORC - comparison between Cisatracurium and Rocuronium | Participants will be followed for the duration of their stay in the post-anaesthesia care unit (PACU), an expected average of 60 minutes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlo Ori, Prof. M.D. | Università degli Studi di Padova - Azienda Ospedaliera di Padova | Study Chair |
| Paolo Feltracco, M.D. | Azienda Ospedaliera di Padova | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera di Padova | Padova | Padova | 35128 | Italy |
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| Rocuronium | Drug | Rocuronium (Esmeron):
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|
| ID | Term |
|---|---|
| D055191 | Delayed Emergence from Anesthesia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C101584 | cisatracurium |
| D000077123 | Rocuronium |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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