A Study of Residual Curarization Incidence in China

Peking University

Status and phase: Unknown; Phase 4

Conditions: PORC (Postoperative Residual Curarization); Perioperative/Postoperative Complications

Treatments: Drug: Cisatracurium; Drug: Rocuronium; Drug: Vecuronium Bromide

Study type: Interventional

Funder types: Other

Identifiers

NCT01690338

CSA-NMB-001

Details and patient eligibility

About

The purpose of this study is to determine the incidence of residual curarization in PACU and relevant risk factors.

Full 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.

Enrollment: 6,090 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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6,090 participants in 3 patient groups

Vecuronium Bromide

Active Comparator group

Description:

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.

Treatment:

Drug: Vecuronium Bromide

cisatracurium

Active Comparator group

Description:

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.

Treatment:

Drug: Cisatracurium

rocuronium

Active Comparator group

Description:

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.

Treatment:

Drug: Rocuronium