Phase 4
N=70
Can Adequacy of Anesthesia Depth and Quality of Recovery be Influenced by the Level of Neuromuscular Blockade?
Neuromuscular Block
Bottom Line
View on ClinicalTrials.gov: NCT02484651 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: BIS Signal Variability Using the Measured Standard Deviation During the Maintenance Phase of Anesthesia — 7.6; 7.8 units on a scale — p=0.651
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sugammadex (Drug); Rocuronium (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Centro Hospitalar do Porto
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY BIS Signal Variability Using the Measured Standard Deviation During the Maintenance Phase of Anesthesia |
7.6; 7.8 | 0.651 |
| PRIMARY Required Effect-site Concentrations of Propofol and Remifentanil |
3000; 2450; 3.26; 2.84 | <0.001 sig |
| SECONDARY 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) |
2; 5; 24; 21; 0; 3 | 0.419 |
| SECONDARY PQRS Satisfaction Results at Day 3 After Surgery |
27; 27; 3; 2; 0; 0 | 0.669 |
Summary
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).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02484651). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.