Can adequacy of anesthesia depth and quality of recovery be influenced by the level of neuromuscular blockade?

Phase 1

• 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.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2014-005238-76-PT
• Lead Sponsor: Centro Hospitalar do Porto

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-11
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 70

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified