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Completed

NCT Number: NCT02484651

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

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).

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Key information

Conditions

Neuromuscular Block

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centro Hospitalar do Porto

Porto, 4099-001, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sugammadex

Drug

Reversal of deep neuromuscular block

Other names: Org 25969, Bridion

Rocuronium

Drug

Maintenance of deep neuromuscular block

Other names: Zemuron, Esmeron

Primary outcomes

  1. 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.

  2. 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

  1. 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)

    Time frame: 15 and 40 minutes after surgery

    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.

  2. PQRS Satisfaction Results at Day 3 After Surgery

    Time frame: 3rd day after surgery

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

Sponsors and collaborators

Lead sponsor

Centro Hospitalar do Porto

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 29, 2015
Registry last updated
Sep 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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