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

NCT02484651 | Completed Phase 4 Results DMC

• 2 other identifiers: 2014.1452014-005238-76
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

Neuromuscular Block

Keywords

deep neuromuscular block; sugammadex; stability of anesthesia; suppression of EMG activity; PQRS; General Anesthesia; Quality of Recovery

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  Maintenance of anesthesia, an average of 130 minutes

Secondary Outcomes (2)

• 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

Study Arms (2)

Standard Group

NO INTERVENTION

Standard Clinical Practice Group - standard neuromuscular block, with a standard rocuronium dose for intubation (0.6 mg/kg). If required, the reversal of neuromuscular block is performed with neostigmine.

Deep NMB group

EXPERIMENTAL

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).

Drug: Sugammadex; Drug: Rocuronium

Interventions

Sugammadex DRUG

Reversal of deep neuromuscular block

Also known as: Org 25969, Bridion

Deep NMB group

Rocuronium DRUG

Maintenance of deep neuromuscular block

Also known as: Zemuron, Esmeron

Deep NMB group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro Hospitalar do Porto: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Centro Hospitalar do Porto

Porto, 4099-001, Portugal

Location

MeSH Terms

Interventions

Sugammadex; Rocuronium

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Androstanols; Androstanes; Steroids; Fused-Ring Compounds

Results Point of Contact

• Title: Prof. Catarina S Nunes
• Organization: Universidade Aberta, Mathematics Section

cnunes@bio-mathematics.org

+351 300 001 705

Study Officials

• Pedro Amorim, MD

  Centro Hospitalar do Porto

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pedro Amorim, MD

Study Record Dates

• First Submitted: June 22, 2015
• First Posted: June 29, 2015
• Study Start: September 1, 2016
• Primary Completion: June 28, 2017
• Study Completion: July 1, 2017
• Last Updated: September 16, 2019
• Results First Posted: September 16, 2019

Record last verified: 2019-09

Locations

PT (1)