N/A
N=350
Incidence of Incomplete Postoperative Neuromuscular Recovery From Anesthesia (P07535)(Completed)
Neuromuscular Blockade
Bottom Line
View on ClinicalTrials.gov: NCT01181349 ↗Enrolled (actual)
350
Serious AEs
0.9%
Results posted
Apr 2012
Primary outcome: Primary: Number of Participants With Train-of-four (TOF) Ratio <0.9 at PACU Arrival — 91 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Neuromuscular Blocking Agent (NMBA) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Train-of-four (TOF) Ratio <0.9 at PACU Arrival |
91 | — |
| SECONDARY Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Identified Neuromuscular Blocking Agents |
13; 42; 35; 73; 31; 118 | =0.169 |
| SECONDARY Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Propofol or Sevoflurane |
60; 169; 4; 24 | — |
| SECONDARY Number of Participants With and Without Postoperative Residual Neuromuscular Blockade Who Received Neuromuscular Blockade Reversal Agents |
71; 162 | =0.01 sig |
| SECONDARY Number of Participants With and Without Postoperative Residual Neuromuscular Blockade With Postoperative Events |
12; 21 | — |
Summary
This is a multicenter, observational study in adult participants undergoing different types of elective surgical procedures requiring general anesthesia. During the first study period, there will be a cross-sectional evaluation of neuromuscular blockade level upon participant arrival at Post Anesthesia Care Units (PACUs). During the second study period, hospital discharge data from the participants will be collected. The purpose of this study is to determine the incidence of incomplete postoperative neuromuscular recovery from anesthesia at PACUs in Portuguese hospitals. This is a cross-sectional and retrospective study.
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- Informed consent signed
- Admission for elective surgery
- Administration of nondepolarizing NMBAs during surgery
Exclusion Criteria
- Admission for emergency surgery
- Reoperation on the same hospital admission
Data sourced from ClinicalTrials.gov (NCT01181349). 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.