Perioperative/Postoperative Complications, PORC (Postoperative Residual Curarization)
Conditions
Keywords
TOFr (train of four ratio), airway extubation, PACU (postanesthesia care unit), PORC (postoperative residual curarization)
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.
Interventions
Administrative protocol of Vecuronium Bromide is determined by each caregiver's clinical experience.
DRUGRocuronium
Administrative protocol of rocuronium is determined by each caregiver's clinical experience.
DRUGCisatracurium
Administrative protocol of cisatracurium is determined by each caregiver's clinical experience
Sponsors
Ruijin Hospital
RenJi Hospital
Shanghai Zhongshan Hospital
The First Affiliated Hospital of Guangzhou Medical University
West China Hospital
Eastern Hepatobiliary Surgery Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Zhujiang Hospital
Chinese PLA General Hospital
First Affiliated Hospital, Sun Yat-Sen University
The First Affiliated Hospital of Zhengzhou University
Tianjin Medical University General Hospital
Xiangya Hospital of Central South University
Central South University
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
First Affiliated Hospital of Xinjiang Medical University
Peking Union Medical College Hospital
First Affiliated Hospital of Zhejiang University
China Medical University Hospital
Hebei Medical University Fourth Hospital
Tongji Hospital
Peking University First Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of TOFr<0.9 | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of TOFr<0.9 | One minute after arriving at PACU | When patients arrive at PACU(an expected average of 15 minutes after surgery is over), monitor the neuromuscular transmission function (TOF ratio) immediately |
| Incidence of TOFr<0.7 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| any sign of residual curarization (listed in description below) | First 24h after surgery | Sign of residual curarization : 1. dyspnea 2. weak hand-grip force 3. Head lift or leg lift time shorter than 5s 4. aspiration 5. respiratory rate \>20/min 6. hypoxemia (SpO2\<90% when O2\>3L/min) |
| pulmonary complications (See description) | participants will be followed for the duration of hospital stay, an expected average of one week | pulmonary complications 1. pneumonia 2. pulmonary atelectasis 3. mechanical ventilation required |
Countries
China
Contacts
Primary ContactXinmin Wu, Doctor
Outcome results
None listed