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

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

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 Overview

• Status: Completed
• Conditions: Neuromuscular Block
• Intervention / Treatment: Drug: Sugammadex; Drug: Rocuronium

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Portugal
  • Porto, Portugal, 4099-001
    • Centro Hospitalar do Porto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Group; 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.
Experimental: 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).	Drug: Sugammadex; Reversal of deep neuromuscular block; Other Names: Bridion; Org 25969; Drug: Rocuronium; Maintenance of deep neuromuscular block; Other Names: Zemuron; Esmeron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	3rd day after surgery

Collaborators and Investigators

• Sponsor: Centro Hospitalar do Porto
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Pedro Amorim, MD, Centro Hospitalar do Porto

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): June 28, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: June 22, 2015
• First Submitted That Met QC Criteria: June 26, 2015
• First Posted (Estimate): June 29, 2015

Study Record Updates

• Last Update Posted (Actual): September 16, 2019
• Last Update Submitted That Met QC Criteria: September 13, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Quality of Recovery; General Anesthesia; sugammadex; deep neuromuscular block; PQRS; stability of anesthesia; suppression of EMG activity
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium
• Other Study ID Numbers: 2014.145; 2014-005238-76 (EudraCT Number)