Incidence of Postoperative Residual Neuromuscular Blockade - A Multicenter, Observational Study in Portugal
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 366
- Locations
- 10
- Primary Endpoint
- Percentage of Patients With Postoperative Residual Neuromuscular Blockade
Study Overview
Brief Summary
This is an epidemiological multicenter, observational, prospective study, designed to determine the incidence of postoperative residual neuromuscular blockade - defined by a TOF (train-of-four) ratio < 0.9 - at PACU arrival.
Subjects aged at least 18 years old (n=360) admitted for different types of elective surgical procedures requiring general anesthesia with neuromuscular blocking agents will be included.
Detailed Description
This is a multicenter, observational/non-interventional study involving adult patients undergoing different types of elective surgical procedures requiring general anesthesia with neuromuscular blocking agents.
The study will have two periods:
- Period 1 - Evaluation at PACU arrival.
- Period 2 - Collection of hospital patient discharge data.
A total of 360 patients will be included from approximately 10 centers in Portugal, where the PACU is adjacent to the Operating Room (OR). Each center should recruit between 30 and 40 patients.
Each subject is considered to be enrolled in the study when the subject has provided written informed consent.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years of age or older;
- •Informed consent signed;
- •Admission for elective surgery;
- •Administration of non-depolarizing NMBAs during surgery
Exclusion Criteria
- •Admission for emergency surgery;
- •Reoperation on the same hospital admission;
- •More than 10 minutes elapsed between extubation and neuromuscular block monitoring at PACU
Outcomes
Primary Outcomes
Percentage of Patients With Postoperative Residual Neuromuscular Blockade
Time Frame: No more than 10 minutes after operating room exit
Percentage of patients arriving PACU with a TOF ratio \< 0.9 measured as average of 3 consecutive TOF stimulations
Secondary Outcomes
- Percentage of Patients With Severe Residual Postoperative Neuromuscular Blockade(no more than 10 minutes after operating room exit)
- Association of Postoperative Residual Blockade and the Use of Reversal Agents(no more than 10 minutes after operating room exit)
- Association of Postoperative Residual Blockade and the Use of Intra-operative Monitoring of Neuromuscular Blockade(no more than 10 minutes after operating room exit)
Investigators
Simao Esteves
MD
Centro Hospitalar do Porto