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
ConditionsSeventy 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]
DrugsBridion
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.
Investigators
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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