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.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005238-76-PT

Enrollment

Registered

2015-03-11

Start date

2016-01-25

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seventy patients with an ASA score of I to III, 18 to 80 years old, scheduled for routine anterior cervical spine surgery in the Centro Hospitalar do Porto will be enrolled.

Interventions

Trade Name: Bridion Pharmaceutical Form: Solution for injection INN or Proposed INN: Sugammadex Other descriptive name: SUGAMMADEX Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients ASA I-III 2. Between 18 – 80 years old 3. Scheduled for routine cervical surgery 4. 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 5. Patients that are able to and do provide a signed informed consent form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: 1. Patients with neuromuscular diseases and severe cardiac and respiratory pathologies 2. Contra indication for any of the drugs used 3. Not able to complete the baseline PQRS test. 4. Indication to perform tracheal intubation using fibroscopy 5. Patients who are pregnant or nursing

Design outcomes

Primary

Measure	Time frame
Primary end point(s): • BIS signal variability using the measured standard deviation during the maintenance phase of anesthesia • Required effect-site concentrations of remifentanil and propofol ;Timepoint(s) of evaluation of this end point: 3 days; Main Objective: The primary objective of this study is to assess if the use of deep neuromuscular blockade reversed with sugammadex, and the consequent suppression of the EMG activity, can improve the overall stability of an anesthetic procedure (guided using BIS monitoring) and allow a reduction in the amount of anesthetic drugs required for adequate anesthesia. The primary hypothesis is that there is a better anesthetic stability in the deep NMB group (Group 2) and that this is translated as a reduction of the BIS signal variability and a reduction in the required effect-site concentrations of propofol and remifentanil (representative of the total drug consumption). ; Secondary Objective: As a secondary objective, we will study the quality of recovery using the PQRS scale to see if maintaining a deep NMB level during surgery has an impact on the patients’ quality of recovery. The secondary hypothesis is that the quality of recovery (PQRS test) is better in the patients of Group 2.	—

Measure

Time frame

Primary end point(s): • BIS signal variability using the measured standard deviation during the maintenance phase of anesthesia • Required effect-site concentrations of remifentanil and propofol ;Timepoint(s) of evaluation of this end point: 3 days; Main Objective: The primary objective of this study is to assess if the use of deep neuromuscular blockade reversed with sugammadex, and the consequent suppression of the EMG activity, can improve the overall stability of an anesthetic procedure (guided using BIS monitoring) and allow a reduction in the amount of anesthetic drugs required for adequate anesthesia. The primary hypothesis is that there is a better anesthetic stability in the deep NMB group (Group 2) and that this is translated as a reduction of the BIS signal variability and a reduction in the required effect-site concentrations of propofol and remifentanil (representative of the total drug consumption). ; Secondary Objective: As a secondary objective, we will study the quality of recovery using the PQRS scale to see if maintaining a deep NMB level during surgery has an impact on the patients’ quality of recovery. The secondary hypothesis is that the quality of recovery (PQRS test) is better in the patients of Group 2.

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Secondary

Measure	Time frame
Secondary end point(s): • PQRS results at 15 and 40 minutes after surgery (taking into account the patient baseline values of the PQRS test done on the pre-anesthetic visit) • PQRS results at day 3 after surgery ;Timepoint(s) of evaluation of this end point: 3 days	—

Countries

Portugal

Contacts

Public ContactPedro Amorim

Centro Hospitalar do Porto

pamorim@vianw.pt00351965 877 728

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026