Cerebral Oxygenation and Metabolism After Reversal Of Rocuronium: Comparison Between Sugammadex Versus Neostigmine
Primary Purpose
Supratentorial Brain Tumor Surgery
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sugammadex
Neostigmine
Sponsored by
About this trial
This is an interventional supportive care trial for Supratentorial Brain Tumor Surgery
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sugammadex
Neostigmine
Arm Description
Patients will receive Sugammadex to antagonise the residual effects of neuromuscular blocking drugs
Patients will receive Neostigmine to antagonise the residual effects of neuromuscular blocking drugs
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Arterio-Jugular oxygen content difference
Ca jO2 = CaO2-CjvO
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
Cerebral Extraction Rate of Oxygen (CEO2)
Calculated as the differences between arterial and jugular bulb O2 saturations, CEO2 = SaO2 - SjvO2
Cerebral Blood Flow equivalent (CBFe)
Which is an index of flow metabolism relationship, calculated as a reciprocal of arterio-jugular O2 content difference
Heart rate
Blood pressure
Central venous pressure
Peripheral oxygen saturation
End-tidal carbon dioxide tension
Sedation level
Total dose of neuromuscular blockade used
Total dose of suggamadex or neostigmine used
Cumulative opioids consumption
Recovery time (RT)
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
Time from start of administration of sugammadex or neostigmine to recovery of the train-of-four (TOF) ratio to 0.9
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02944175
Brief Title
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
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
September 1, 2019 (Anticipated)
Study Completion Date
October 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supratentorial Brain Tumor Surgery
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sugammadex
Arm Type
Experimental
Arm Description
Patients will receive Sugammadex to antagonise the residual effects of neuromuscular blocking drugs
Arm Title
Neostigmine
Arm Type
Active Comparator
Arm Description
Patients will receive Neostigmine to antagonise the residual effects of neuromuscular blocking drugs
Intervention Type
Drug
Intervention Name(s)
Sugammadex
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Neostigmine
Intervention Description
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
Primary Outcome Measure Information:
Title
Time to recovery of the train-of-four (TOF) ratio to 0.9
Description
The time from start of administration of sugammadex or neostigmine to recovery of the train-of-four (TOF) ratio to 0.9
Time Frame
For 1 hour after surgery
Secondary Outcome Measure Information:
Title
Arterio-Jugular oxygen content difference
Description
Ca jO2 = CaO2-CjvO
Time Frame
For 6 hours after the start of surgery
Title
Estimated cerebral metabolic rate for oxygen (eCMRO2)
Description
eCMRO2=Ca- jO2 x(PaCO2 ∕ 100) Where ……. Ca jO2 is arterio-jugular O2 content difference.
PaCO2 is arterial CO2 tension
Time Frame
For 6 hours after the start of surgery
Title
Cerebral Extraction Rate of Oxygen (CEO2)
Description
Calculated as the differences between arterial and jugular bulb O2 saturations, CEO2 = SaO2 - SjvO2
Time Frame
For 6 hours after the start of surgery
Title
Cerebral Blood Flow equivalent (CBFe)
Description
Which is an index of flow metabolism relationship, calculated as a reciprocal of arterio-jugular O2 content difference
Time Frame
For 6 hours after the start of surgery
Title
Heart rate
Time Frame
For 6 hours after the start of surgery
Title
Blood pressure
Time Frame
For 6 hours after the start of surgery
Title
Central venous pressure
Time Frame
For 6 hours after the start of surgery
Title
Peripheral oxygen saturation
Time Frame
For 6 hours after the start of surgery
Title
End-tidal carbon dioxide tension
Time Frame
For 6 hours after the start of surgery
Title
Sedation level
Time Frame
For 1 hour after extubation
Title
Total dose of neuromuscular blockade used
Time Frame
For 6 hours after the start of surgery
Title
Total dose of suggamadex or neostigmine used
Time Frame
For 30 min after the end of surgery
Title
Cumulative opioids consumption
Time Frame
For 6 hours after the start of surgery
Title
Recovery time (RT)
Description
the time of restoration of neuromuscular conduction sufficient for extubation from stoppage of anaesthesia till the patient can obey commands
Time Frame
For 1 hour after surgery
Title
Time between administration of sugammadex or neostigmine to recovery
Description
Time from start of administration of sugammadex or neostigmine to recovery of the train-of-four (TOF) ratio to 0.9
Time Frame
For 1 hour after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherif A Mousa
Organizational Affiliation
Department of Anaesthesia, Surgical Intensive Care and Pain Medicine, College of Medicine, Mansoura University, Mansoura, Egypt
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Cerebral Oxygenation and Metabolism After Reversal Of Rocuronium: Comparison Between Sugammadex Versus Neostigmine
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