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Clinical Trials/EUCTR2014-005238-76-PT
EUCTR2014-005238-76-PT
Active, Not Recruiting
Phase 1

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.

Centro Hospitalar do Porto0 sites70 target enrollmentMarch 11, 2015

Overview

Phase
Phase 1
Intervention
Not specified
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.
Sponsor
Centro Hospitalar do Porto
Enrollment
70
Status
Active, Not Recruiting
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 11, 2015
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Centro Hospitalar do Porto

Eligibility 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

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

Outcomes

Primary Outcomes

Not specified

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