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

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

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.

Study Overview

• Status: Unknown
• Conditions: Supratentorial Brain Tumor Surgery
• Intervention / Treatment: Drug: Sugammadex; Drug: Neostigmine

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Sugammadex; Patients will receive Sugammadex to antagonise the residual effects of neuromuscular blocking drugs	Drug: Sugammadex; 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
ACTIVE_COMPARATOR: Neostigmine; Patients will receive Neostigmine to antagonise the residual effects of neuromuscular blocking drugs	Drug: Neostigmine; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Sherif A Mousa, Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (ANTICIPATED): September 1, 2019
• Study Completion (ANTICIPATED): October 1, 2019

Study Registration Dates

• First Submitted: October 20, 2016
• First Submitted That Met QC Criteria: October 21, 2016
• First Posted (ESTIMATE): October 25, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2018
• Last Update Submitted That Met QC Criteria: October 18, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Cholinesterase Inhibitors; Parasympathomimetics; Neostigmine
• Other Study ID Numbers: MD ∕16.07.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED