Cerebral Oxygenation and Metabolism After Reversal Of Rocuronium: Comparison Between Sugammadex Versus Neostigmine

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cerebral Oxygenation and Metabolism After Reversal Of Rocuronium Neuromuscular Blockade In Cases Of Supratentorial Tumors: A Comparative Study Between Sugammadex Versus Neostigmine

Conditions
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Supratentorial Brain Tumor Surgery

Intervention / Treatment
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* Drug: Sugammadex
* Drug: Neostigmine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists physical class status I - III . Patients scheduled for elective supratentorial brain tumor resection Exclusion Criteria: Severe uncompensated cardiac disease. Severe uncompensated respiratory disease. Severe uncompensated hepatic disease. Severe uncompensated renal disease. Morbidly obese patients. Documented hypersensitivity to one of the used drugs. Surgery in sitting position Surgery in prone position Patients with altered level of consciousness. Pregnancy.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sugammadex<br>Patients will receive Sugammadex to antagonise the residual effects of neuromuscular blocking drugs | Drug: Sugammadex<br>* 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<br>|
| Active Comparator: Neostigmine<br>Patients will receive Neostigmine to antagonise the residual effects of neuromuscular blocking drugs | Drug: Neostigmine<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. PaCO2 is arterial CO2 tension | 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 |