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

Not Applicable

• Conditions: Supratentorial Brain Tumor Surgery
• Interventions: Drug: Sugammadex; Drug: Neostigmine

• Registration Number: NCT02944175
• Lead Sponsor: Mansoura University

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-10-20
• Study First Submitted QC: 2016-10-21
• Study First Posted: 2016-10-25
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-18
• Last Update Posted: 2018-10-19
• Primary Completion: 2019-09-01
• Study Completion: 2019-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugammadex	Sugammadex	Patients will receive Sugammadex to antagonise the residual effects of neuromuscular blocking drugs
Neostigmine	Neostigmine	Patients will receive Neostigmine to antagonise the residual effects of neuromuscular blocking drugs

Primary Outcome Measures

Name	Time	Method
Time to recovery of the train-of-four (TOF) ratio to 0.9	For 1 hour after surgery	The time from start of administration of sugammadex or neostigmine to recovery of the train-of-four (TOF) ratio to 0.9

Secondary Outcome Measures

Name	Time	Method
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
Arterio-Jugular oxygen content difference	For 6 hours after the start of surgery	Ca jO2 = CaO2-CjvO
Estimated cerebral metabolic rate for oxygen (eCMRO2)	For 6 hours after the start of surgery	eCMRO2=Ca- jO2 x(PaCO2 ∕ 100) Where ....... Ca jO2 is arterio-jugular O2 content difference.; * PaCO2 is arterial CO2 tension
Cerebral Extraction Rate of Oxygen (CEO2)	For 6 hours after the start of surgery	Calculated as the differences between arterial and jugular bulb O2 saturations, CEO2 = SaO2 - SjvO2
Cerebral Blood Flow equivalent (CBFe)	For 6 hours after the start of surgery	Which is an index of flow metabolism relationship, calculated as a reciprocal of arterio-jugular O2 content difference
Heart rate	For 6 hours after the start of surgery
Cumulative opioids consumption	For 6 hours after the start of surgery
Recovery time (RT)	For 1 hour after surgery	the time of restoration of neuromuscular conduction sufficient for extubation from stoppage of anaesthesia till the patient can obey commands
Time between administration of sugammadex or neostigmine to recovery	For 1 hour after surgery	Time from start of administration of sugammadex or neostigmine to recovery of the train-of-four (TOF) ratio to 0.9