A Perspective, Multicentre, Randomized，Blind Study of Residual Curarization Incidence in China
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 6,090
- Locations
- 22
- Primary Endpoint
- incidence of TOFr<0.9
Study Overview
Brief Summary
The purpose of this study is to determine the incidence of residual curarization in PACU and relevant risk factors.
Detailed Description
In the last twenty years, residual curarization in PACU (Post Anesthesia Care Unit) has become a common problem in clinical practice and poses high risk to patients. The residual curarization incidence of Neuromuscular blocking agents (NMBA) varies very much between different studies. These differences indicates the necessity of further study. In China, there is no common view of the harmfulness of residual curarization and its complications. The consensus on the necessity of neuromuscular transmission monitoring and neuromuscular blockade antagonist has not been reached yet. There is also no similar large-scale survey in China. In this case, the investigators conduct this large scale multicentre study, which is designed to learn the incidence of residual curarization and its complications. Further analysis of risk factors will also been made. All these efforts are hoped to fill the data gap and provide reliable evidences for rational use of NMBA.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 18 or older
- •Nondepolarized NMBA will be given during surgery and tracheal extubation will be performed after surgery
- •Willing to comply with all study procedures and provide signed and dated informed consent
Exclusion Criteria
- •Allergic reaction to gel electrode
- •Neuromuscular disorders and hepatic or renal dysfunction
- •Scheduled to receive mechanical ventilation therapy
- •Involved in other clinical trials
- •Body position and surgical procedure affecting TOF-Watch SX normal function
Arms & Interventions
Vecuronium Bromide
Patients who will be performed general anesthesia and tracheal intubation. Vecuronium will be used during surgery and tracheal extubation is scheduled when surgery is over.
Intervention: Vecuronium Bromide (Drug)
cisatracurium
Patients who will be performed general anesthesia and tracheal intubation. Cisatracurium will be used during surgery and tracheal extubation is scheduled when surgery is over.
Intervention: Cisatracurium (Drug)
rocuronium
Patients who will be performed general anesthesia and tracheal intubation. Rocuronium will be used during surgery and tracheal extubation is scheduled when surgery is over.
Intervention: Rocuronium (Drug)
Outcomes
Primary Outcomes
incidence of TOFr<0.9
Time Frame: From tracheal extubation to 1 minute after extubation
Once tracheal extubation is performed after the surgery is over, monitor the neuromuscular transmission function (TOF ratio) immediately.
Secondary Outcomes
- Incidence of TOFr<0.9(One minute after arriving at PACU)
- Incidence of TOFr<0.7(One minute after arriving at PACU)
Investigators
Xinmin Wu
Clinical Professor
Peking University First Hospital