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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
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Supratentorial Brain Tumor Surgery

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept 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.

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

    First Posted
    October 20, 2016
    Last Updated
    October 18, 2018
    Sponsor
    Mansoura University
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    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

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

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