Can Adequacy of Anesthesia Depth and Quality of Recovery be Influenced by the Level of Neuromuscular Blockade?

Centro Hospitalar do Porto70 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neuromuscular Block

Interventions

SugammadexDRUG

Reversal of deep neuromuscular block

RocuroniumDRUG

Maintenance of deep neuromuscular block

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Centro Hospitalar do Porto

Porto, Portugal

Outcomes

Primary Outcomes

BIS Signal Variability Using the Measured Standard Deviation During the Maintenance Phase of Anesthesia

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.

Time frame: Maintenance of anesthesia, an average of 130 minutes

Required Effect-site Concentrations of Propofol and Remifentanil

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).

Time frame: Maintenance of anesthesia, an average of 130 minutes

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)

PQRS(Post-operative Quality Recovery Scale) recovery rate at 15 minutes post surgery and PQRS recovery rate at 40 minutes post surgery. Recovery is defined as returning to PQRS baseline values.

Time frame: 15 and 40 minutes after surgery

PQRS Satisfaction Results at Day 3 After Surgery

Patient satisfaction with anesthetic care rated as: Not satisfied, A little satisfied, Moderately satisfied ,Satisfied, Totally Satisfied

Time frame: 3rd day after surgery

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.