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A Study of Residual Curarization Incidence in China

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2013 by Peking University First Hospital.
Recruitment status was:  Recruiting
Sponsor:
Collaborators:
Ruijin Hospital
RenJi Hospital
Shanghai Zhongshan Hospital
The First Affiliated Hospital of Guangzhou Medical University
West China Hospital
Eastern Hepatobiliary Surgery Hospital
Wuhan Union Hospital, China
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
The First Teaching 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
Information provided by (Responsible Party):
Xinmin Wu, Peking University First Hospital
ClinicalTrials.gov Identifier:
NCT01690338
First received: September 4, 2012
Last updated: May 22, 2013
Last verified: May 2013
  Purpose
The purpose of this study is to determine the incidence of residual curarization in PACU and relevant risk factors.

Condition Intervention Phase
Perioperative/Postoperative Complications
PORC (Postoperative Residual Curarization)
Drug: Vecuronium Bromide
Drug: Rocuronium
Drug: Cisatracurium
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: A Perspective, Multicentre, Randomized,Blind Study of Residual Curarization Incidence in China

Resource links provided by NLM:


Further study details as provided by Peking University First Hospital:

Primary Outcome Measures:
  • incidence of TOFr<0.9 [ Time Frame: From tracheal extubation to 1 minute after extubation ] [ Designated as safety issue: Yes ]
    Once tracheal extubation is performed after the surgery is over, monitor the neuromuscular transmission function (TOF ratio) immediately.


Secondary Outcome Measures:
  • Incidence of TOFr<0.9 [ Time Frame: One minute after arriving at PACU ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: From tracheal extubation to 1 minute after extubation ] [ Designated as safety issue: Yes ]
    Once tracheal extubation is performed after the surgery is over, monitor the neuromuscular transmission function (TOF ratio) immediately.

  • Incidence of TOFr<0.7 [ Time Frame: One minute after arriving at PACU ] [ Designated as safety issue: Yes ]
    When patients arrive at PACU(an expected average of 15 minutes after surgery is over), monitor the neuromuscular transmission function (TOF ratio) immediately


Other Outcome Measures:
  • any sign of residual curarization (listed in description below) [ Time Frame: First 24h after surgery ] [ Designated as safety issue: Yes ]

    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) [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of one week ] [ Designated as safety issue: Yes ]

    pulmonary complications

    1. pneumonia
    2. pulmonary atelectasis
    3. mechanical ventilation required


Estimated Enrollment: 6090
Study Start Date: October 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: Vecuronium Bromide
Administrative protocol of Vecuronium Bromide is determined by each caregiver's clinical experience.
Other Name: Norcuron
Active Comparator: 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.
Drug: Cisatracurium
Administrative protocol of cisatracurium is determined by each caregiver's clinical experience
Other Name: Nimbex
Active Comparator: 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.
Drug: Rocuronium
Administrative protocol of rocuronium is determined by each caregiver's clinical experience.
Other Name: Esmeron

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01690338

Locations
China, Beijing
Chinese PLA General Hospital
Beijing, Beijing, China, 100000
Peking Union Medical College Hospital
Beijing, Beijing, China, 100000
Peking University First Hospital
Beijing, Beijing, China, 100034
China, Guangdong
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510000
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510000
Zhujiang Hospital Southern Medical University
Guangzhou, Guangdong, China, 510000
China, Hebei
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, China, 050000
China, Henan
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000
China, Hubei
Tongji Hospital, Tongji Medical College of HUST
Wuhan, Hubei, China, 430000
Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
China, Hunan
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410000
Xiangya Hospital of Central South University
Changsha, Hunan, China, 410000
China, Liaoning
China Medical University Hospital
Shenyang, Liaoning, China, 110000
China, Shanghai
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai, China, 200000
RenJi Hospital
Shanghai, Shanghai, China, 200000
Ruijin Hospital
Shanghai, Shanghai, China, 200000
Shanghai First People's Hospital
Shanghai, Shanghai, China, 200000
Shanghai Zhongshan Hospital
Shanghai, Shanghai, China, 200000
China, Sichuan
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610000
China, Tianjin
Tianjin Medical University General Hospital
Tianjin, Tianjin, China, 300000
China, Zhejiang
The First Affiliated Hospital Of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310000
Sponsors and Collaborators
Peking University First Hospital
Ruijin Hospital
RenJi Hospital
Shanghai Zhongshan Hospital
The First Affiliated Hospital of Guangzhou Medical University
West China Hospital
Eastern Hepatobiliary Surgery Hospital
Wuhan Union Hospital, China
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
The First Teaching 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
Investigators
Principal Investigator: Xinmin Wu, Doctor Peking University First Hospital
  More Information

Publications:

Responsible Party: Xinmin Wu, Clinical Professor, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT01690338     History of Changes
Other Study ID Numbers: CSA-NMB-001 
Study First Received: September 4, 2012
Last Updated: May 22, 2013
Health Authority: China: Ethics Committee

Keywords provided by Peking University First Hospital:
TOFr (train of four ratio)
airway extubation
PACU (postanesthesia care unit)
PORC (postoperative residual curarization)

Additional relevant MeSH terms:
Postoperative Complications
Delayed Emergence from Anesthesia
Pathologic Processes
Rocuronium
Atracurium
Vecuronium Bromide
Cisatracurium
Bromides
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 05, 2016