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

Centro Hospitalar do Porto

Status and phase: Completed; Phase 4

Conditions: Neuromuscular Block

Treatments: Drug: Sugammadex; Drug: Rocuronium

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02484651

2014-005238-76 (EudraCT Number)

2014.145

Details and patient eligibility

About

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).

Enrollment: 70 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Standard Group

No Intervention group

Description:

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 group

Description:

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).

Treatment:

Drug: Rocuronium

Drug: Sugammadex