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

Condition(s) targeted: Neuromuscular Block

Intervention: Sugammadex (Drug); Rocuronium (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Centro Hospitalar do Porto

Official(s) and/or principal investigator(s):
Pedro Amorim, MD, Principal Investigator, Affiliation: Centro Hospitalar do Porto

Overall contact:
Pedro Amorim, MD, Phone: 00351 965 877 728, Email: pamorim@vianw.pt

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).

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

BIS signal variability using the measured standard deviation during the maintenance phase of anesthesia

Required effect-site concentrations of propofol and remifentanil

Secondary outcome:

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 satisfaction results at day 3 after surgery

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

Pedro Amorim, MD, Phone: 00351 965 877 728, Email: pamorim@vianw.pt

Centro Hospitalar do Porto, Porto 4099-001, Portugal; Not yet recruiting
Pedro Amorim, MD, Phone: 00351 965 877 728, Email: pamorim@vianw.pt
Simão Esteves, MD, Phone: 00351917534014, Email: simao.esteves@netcabo.pt
Pedro Amorim, MD, Principal Investigator
Catarina S Nunes, MSci, PhD, Sub-Investigator
Simão Esteves, MD, Sub-Investigator
Humberto Machado, MD, PhD, Sub-Investigator

Starting date: July 2015
Last updated: June 26, 2015