Can Adequacy of Anesthesia Depth and Quality of Recovery be Influenced by the Level of Neuromuscular Blockade: a Randomized Controlled Study Assessing Propofol and Remifentanil Requirements and Quality of Recovery in Patients With a Standard Practice of Non-deep Rocuronium Neuromuscular Blockade Versus Deep Neuromuscular Blockade Reversed With Sugammadex
Overview
- Phase
- Phase 4
- Intervention
- Sugammadex
- Conditions
- Neuromuscular Block
- Sponsor
- Centro Hospitalar do Porto
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- BIS Signal Variability Using the Measured Standard Deviation During the Maintenance Phase of Anesthesia
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The investigators hypothesize that an anesthetic protocol maintaining deep neuromuscular block throughout the entire surgical procedure followed by sugammadex reversal, would suppress EMG activity and result in improved anesthetic stability by reducing the variability of the Bispectral Index of the EEG, and be beneficial by reducing the total doses of the anesthetic drugs propofol and remifentanil required to maintain an adequate level of anesthesia (BIS between 40 and 60).
Investigators
Pedro Amorim, MD
Pedro Amorim, MD
Centro Hospitalar do Porto
Eligibility Criteria
Inclusion Criteria
- •Patients ASA I-III
- •Between 18 - 80 years old
- •Scheduled for routine cervical surgery
- •Minimum duration of surgery is 90 minutes and performed with total intravenous anaesthesia (TIVA) with the hypnotic propofol, the analgesic remifentanil and the neuromuscular relaxant rocuronium
- •Patients that are able to and do provide a signed informed consent form
Exclusion Criteria
- •Patients with neuromuscular diseases and severe cardiac and respiratory pathologies
- •Contra indication for any of the drugs used
- •Not able to complete the baseline PQRS test.
- •Indication to perform tracheal intubation using fibroscopy
- •Patients who are pregnant or nursing
Arms & Interventions
Deep NMB group
Deep Neuromuscular Block group - with a standard rocuronium dose for intubation (0.6 mg/kg), followed by a constant infusion of rocuronium (10-15 ug/kg/min) to guarantee a PTC less or equal to 2 on the TOF monitor (PTC is evaluated every 5 minutes). The reversal of neuromuscular block is performed with Sugammadex (4 mg/kg).
Intervention: Sugammadex
Deep NMB group
Deep Neuromuscular Block group - with a standard rocuronium dose for intubation (0.6 mg/kg), followed by a constant infusion of rocuronium (10-15 ug/kg/min) to guarantee a PTC less or equal to 2 on the TOF monitor (PTC is evaluated every 5 minutes). The reversal of neuromuscular block is performed with Sugammadex (4 mg/kg).
Intervention: Rocuronium
Outcomes
Primary Outcomes
BIS Signal Variability Using the Measured Standard Deviation During the Maintenance Phase of Anesthesia
Time Frame: Maintenance of anesthesia, an average of 130 minutes
BIS (Bispetral Index of the EEG) sample standard deviation during the maintenance phase of anesthesia was used as a measure of signal variability, maintenance phase is defined as the time between the first time the BIS signal drops below 60 after loss of consciousness, until the time the BIS signal goes above 60 after the propofol infusion is stopped. BIS signal varies between 0 to 100. BIS values near 100 represent an "awake" clinical state while 0 denotes the maximal effect an isoelectric EEG. The aim was to maintain the BIS value within a target range of 40 to 60. The higher the BIS sample standard deviation the higher the oscillation around the sample mean.
Required Effect-site Concentrations of Propofol and Remifentanil
Time Frame: Maintenance of anesthesia, an average of 130 minutes
Mean effect-site concentration of propofol required during maintenance of anesthesia (using target controlled infusion). Mean effect-site concentration of remifentanil required during maintenance of anesthesia (using target controlled infusion).
Secondary Outcomes
- PQRS Results at 15 and 40 Minutes After Surgery (Taking Into Account the Patient Baseline Values of the PQRS Test Done on the Preanesthetic Visit)(15 and 40 minutes after surgery)
- PQRS Satisfaction Results at Day 3 After Surgery(3rd day after surgery)