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

Neuromuscular Block Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02484651
• Other study ID #: 2014.145
• Secondary ID: 2014-005238-76
• Status: Completed
• Phase: Phase 4
• Start date: September 2016
• Est. completion date: July 1, 2017

Study information

• Verified date: September 2019
• Source: Centro Hospitalar do Porto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 1, 2017
• Est. primary completion date: June 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuromuscular Block

Intervention

Drug:
• Sugammadex
Reversal of deep neuromuscular block
• Rocuronium
Maintenance of deep neuromuscular block

Locations

Country	Name	City	State
Portugal	Centro Hospitalar do Porto	Porto

Sponsors (2)

Lead Sponsor	Collaborator
Centro Hospitalar do Porto	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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