Clinical trial NCT02944175: Cerebral Oxygenation and Metabolism After Reversal Of Rocuronium: Comparison Between Sugammadex Versus Neostigmine
Official title: Cerebral Oxygenation and Metabolism After Reversal Of Rocuronium Neuromuscular Blockade In Cases Of Supratentorial Tumors: A Comparative Study Between Sugammadex Versus Neostigmine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Supratentorial Brain Tumor Surgery
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2016-10-25
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to recovery of the train-of-four (TOF) ratio to 0.9
timeFrame: For 1 hour after surgery
Secondary outcomes:
measure: Arterio-Jugular oxygen content difference
timeFrame: For 6 hours after the start of surgery
measure: Estimated cerebral metabolic rate for oxygen (eCMRO2)
timeFrame: For 6 hours after the start of surgery
measure: Cerebral Extraction Rate of Oxygen (CEO2)
timeFrame: For 6 hours after the start of surgery
measure: Cerebral Blood Flow equivalent (CBFe)
timeFrame: For 6 hours after the start of surgery
measure: Heart rate
timeFrame: For 6 hours after the start of surgery
measure: Blood pressure
timeFrame: For 6 hours after the start of surgery
measure: Central venous pressure
timeFrame: For 6 hours after the start of surgery
measure: Peripheral oxygen saturation
timeFrame: For 6 hours after the start of surgery
measure: End-tidal carbon dioxide tension
timeFrame: For 6 hours after the start of surgery
measure: Sedation level
timeFrame: For 1 hour after extubation
measure: Total dose of neuromuscular blockade used
timeFrame: For 6 hours after the start of surgery
measure: Total dose of suggamadex or neostigmine used
timeFrame: For 30 min after the end of surgery
measure: Cumulative opioids consumption
timeFrame: For 6 hours after the start of surgery
measure: Recovery time (RT)
timeFrame: For 1 hour after surgery
measure: Time between administration of sugammadex or neostigmine to recovery
timeFrame: For 1 hour after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
name: Sherif A Mousa
role: STUDY_CHAIR
References: