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A Study of Residual Curarization Incidence in China

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ClinicalTrials.gov Identifier: NCT01690338
Recruitment Status : Unknown
Verified May 2013 by Xinmin Wu, Peking University First Hospital.
Recruitment status was:  Recruiting
First Posted : September 21, 2012
Last Update Posted : May 24, 2013
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
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
Information provided by (Responsible Party):
Xinmin Wu, Peking University First Hospital

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

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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6090 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Perspective, Multicentre, Randomized,Blind Study of Residual Curarization Incidence in China
Study Start Date : October 2012
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : December 2014


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Incidence of TOFr<0.9 [ Time Frame: 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

  2. Incidence of TOFr<0.7 [ 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.

  3. Incidence of TOFr<0.7 [ Time Frame: 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


Other Outcome Measures:
  1. any sign of residual curarization (listed in description below) [ Time Frame: 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)

  2. pulmonary complications (See description) [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01690338


Contacts
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Contact: Xinmin Wu, Doctor +86 13910616740 xmwu2784@hotmail.com

Locations
Show Show 22 study locations
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
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
Investigators
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Principal Investigator: Xinmin Wu, Doctor Peking University First Hospital
Publications:

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Responsible Party: Xinmin Wu, Clinical Professor, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT01690338    
Other Study ID Numbers: CSA-NMB-001
First Posted: September 21, 2012    Key Record Dates
Last Update Posted: May 24, 2013
Last Verified: May 2013
Keywords provided by Xinmin Wu, Peking University First Hospital:
TOFr (train of four ratio)
airway extubation
PACU (postanesthesia care unit)
PORC (postoperative residual curarization)
Additional relevant MeSH terms:
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Postoperative Complications
Delayed Emergence from Anesthesia
Pathologic Processes
Bromides
Rocuronium
Vecuronium Bromide
Cisatracurium
Anticonvulsants
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action