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Cholinesterase inhibitors such as Neostigmine and Edrophonium have been used to reverse neuromuscular blockade after surgery. However, these drugs have a relatively slow onset and have adverse effects associated with stimulation of muscarinic receptors. In addition, neostigmine cannot be used to reverse profound blockade.
Anesthetics may exert their effects on various facets of cerebral function such as cerebral metabolic rate (CMRO2), cerebral blood flow (CBF), cerebral blood flow-metabolism coupling, intra cranial pressure (ICP), autoregulation, vascular response to CO2 and brain electrical activity. The net result of all these effects of the anaesthetic agents combined with their systemic effects may prove beneficial or detrimental to an already diseased brain.
In neurosurgical patients, clear and rapid recovery is required to early assess the neurological status and to maintain the cerebral oxygenation and metabolism within the normal physiological values which may be saved by sugammadex.
The aim of this study is to compare Sugammadex versus neostigmine as a reversal to the neuromuscular blockade of rocuronium in patients undergoing supratentorial tumors resection. Comparison will include hemodynamics, respiratory effort and degree of sedation.
Indicators of global cerebral oxygenation and haemodynamics will be calculated using jugular bulb and peripheral arterial blood sampling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sugammadex | Experimental | Patients will receive Sugammadex to antagonise the residual effects of neuromuscular blocking drugs |
|
| Neostigmine | Active Comparator | Patients will receive Neostigmine to antagonise the residual effects of neuromuscular blocking drugs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugammadex | Drug | At the end of surgery and when 2 responses were achieved on the TOF stimulation, Sugammadex 2 mg·kg-1 was administered intravenously in Group S |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to recovery of the train-of-four (TOF) ratio to 0.9 | The time from start of administration of sugammadex or neostigmine to recovery of the train-of-four (TOF) ratio to 0.9 | For 1 hour after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Arterio-Jugular oxygen content difference | Ca jO2 = CaO2-CjvO | For 6 hours after the start of surgery |
| Estimated cerebral metabolic rate for oxygen (eCMRO2) | eCMRO2=Ca- jO2 x(PaCO2 ∕ 100) Where ……. Ca jO2 is arterio-jugular O2 content difference.
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sherif A Mousa | Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt | Study Chair |
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| ID | Term |
|---|---|
| D000077122 | Sugammadex |
| D009388 | Neostigmine |
| ID | Term |
|---|---|
| D047408 | gamma-Cyclodextrins |
| D003505 | Cyclodextrins |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| Neostigmine | Drug | At the end of surgery and when 2 responses were achieved on the TOF stimulation neostigmine 0.05 mg·kg-1 + atropine 0.02 mg·kg-1 was administered intravenously |
|
| For 6 hours after the start of surgery |
| Cerebral Extraction Rate of Oxygen (CEO2) | Calculated as the differences between arterial and jugular bulb O2 saturations, CEO2 = SaO2 - SjvO2 | For 6 hours after the start of surgery |
| Cerebral Blood Flow equivalent (CBFe) | Which is an index of flow metabolism relationship, calculated as a reciprocal of arterio-jugular O2 content difference | For 6 hours after the start of surgery |
| Heart rate | For 6 hours after the start of surgery |
| Blood pressure | For 6 hours after the start of surgery |
| Central venous pressure | For 6 hours after the start of surgery |
| Peripheral oxygen saturation | For 6 hours after the start of surgery |
| End-tidal carbon dioxide tension | For 6 hours after the start of surgery |
| Sedation level | For 1 hour after extubation |
| Total dose of neuromuscular blockade used | For 6 hours after the start of surgery |
| Total dose of suggamadex or neostigmine used | For 30 min after the end of surgery |
| Cumulative opioids consumption | For 6 hours after the start of surgery |
| Recovery time (RT) | the time of restoration of neuromuscular conduction sufficient for extubation from stoppage of anaesthesia till the patient can obey commands | For 1 hour after surgery |
| Time between administration of sugammadex or neostigmine to recovery | Time from start of administration of sugammadex or neostigmine to recovery of the train-of-four (TOF) ratio to 0.9 | For 1 hour after surgery |
| D003912 |
| Dextrins |
| D013213 | Starch |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D050338 | Phenylammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |