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

Mansoura University

Status: Unknown

Conditions: Supratentorial Brain Tumor Surgery

Treatments: Drug: Neostigmine; Drug: Sugammadex

Study type: Interventional

Funder types: Other

Identifiers

NCT02944175

MD ∕16.07.22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Sugammadex

Experimental group

Description:

Patients will receive Sugammadex to antagonise the residual effects of neuromuscular blocking drugs

Treatment:

Drug: Sugammadex

Neostigmine

Active Comparator group

Description:

Patients will receive Neostigmine to antagonise the residual effects of neuromuscular blocking drugs

Treatment:

Drug: Neostigmine