- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01690338
A Study of Residual Curarization Incidence in China
May 22, 2013 updated by: Xinmin Wu, Peking University First Hospital
A Perspective, Multicentre, Randomized,Blind Study of Residual Curarization Incidence in China
The purpose of this study is to determine the incidence of residual curarization in PACU and relevant risk factors.
Study Overview
Status
Unknown
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
6090
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xinmin Wu, Doctor
- Phone Number: +86 13910616740
- Email: xmwu2784@hotmail.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100034
- Recruiting
- Peking University First Hospital
-
Contact:
- Yuan Zeng, Doctor
- Phone Number: +86 13520703600
- Email: yuan_zeng@sina.com
-
Principal Investigator:
- Yuan Zeng, Doctor
-
Beijing, Beijing, China, 100000
- Recruiting
- Peking Union Medical College Hospital
-
Contact:
- Jing Zhao, Doctor
- Phone Number: +86 13901048114
- Email: Zhaojing1009@yahoo.com.cn
-
Beijing, Beijing, China, 100000
- Recruiting
- Chinese PLA General hospital
-
Contact:
- Weidong Mi, Doctor
- Phone Number: +86 13381082966
- Email: wwdd1962@yahoo.com.cn
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510000
- Recruiting
- The First Affiliated Hospital of Guangzhou Medical University
-
Contact:
- Qinglong Dong, Doctor
- Phone Number: 13602837397
- Email: qldong@163.net
-
Guangzhou, Guangdong, China, 510000
- Recruiting
- First Affiliated Hospital, Sun Yat-Sen University
-
Contact:
- Wenqi Huang, Doctor
- Phone Number: +86 13802963182
- Email: huangwenqi86@yahoo.com.cn
-
Guangzhou, Guangdong, China, 510000
- Recruiting
- Zhujiang Hospital Southern Medical University
-
Contact:
- Shiyuan Xu, Doctor
- Phone Number: +86 13609727860
- Email: xushiyuan355@yahoo.com.cn
-
-
Hebei
-
Shijiazhuang, Hebei, China, 050000
- Recruiting
- Hebei Medical University Fourth Hospital
-
Contact:
- Zixian Song, Doctor
- Phone Number: +86 13400312688
- Email: zixiansong@126.com
-
-
Henan
-
Zhengzhou, Henan, China, 450000
- Recruiting
- The First Affiliated Hospital of Zhengzhou University
-
Contact:
- Wei Zhang, Doctor
- Phone Number: +86 13673996966
- Email: Zhangw571012@126.com
-
-
Hubei
-
Wuhan, Hubei, China, 430000
- Recruiting
- Tongji Hospital, Tongji Medical College of HUST
-
Contact:
- Ailin Luo, Doctor
- Phone Number: +86 13507122565
- Email: ailinluo@yahoo.cn
-
Wuhan, Hubei, China, 430000
- Recruiting
- Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
Contact:
- Qingping Wu, Doctor
- Phone Number: +86 13971605283
- Email: Wqp1968@163.com
-
-
Hunan
-
Changsha, Hunan, China, 410000
- Recruiting
- Xiangya Hospital of Central South University
-
Contact:
- Qulian Guo, Doctor
- Phone Number: +86 13707315866
- Email: qulianguo@hotmail.com
-
Changsha, Hunan, China, 410000
- Recruiting
- The second Xiangya Hospital of Central South University
-
Contact:
- Junmei Xu, Doctor
- Phone Number: +86 13975148864
- Email: 13975148864@139.com
-
-
Liaoning
-
Shenyang, Liaoning, China, 110000
- Recruiting
- China Medical University Hospital
-
Contact:
- Hong Ma, Doctor
- Phone Number: +86 13840366406
- Email: mahong5466@yahoo.com
-
-
Shanghai
-
Shanghai, Shanghai, China, 200000
- Recruiting
- Eastern Hepatobiliary Surgery Hospital
-
Contact:
- Weifeng Yu, Doctor
- Phone Number: +86 13901961704
- Email: Ywf808@yeah.net
-
Shanghai, Shanghai, China, 200000
- Recruiting
- Renji Hospital
-
Contact:
- Xiangrui Wang, Doctor
- Phone Number: 13701901953
- Email: xiangrui68@163.com
-
Shanghai, Shanghai, China, 200000
- Recruiting
- Ruijin Hospital
-
Contact:
- Qingsheng Xue, Doctor
- Phone Number: +86 13611909814
- Email: xueqingsheng@yahoo.com.cn
-
Shanghai, Shanghai, China, 200000
- Recruiting
- Shanghai First People's Hospital
-
Contact:
- Yingtian Wang, Doctor
- Phone Number: +86 13386259639
- Email: wang_didi26@yahoo.com.cn
-
Shanghai, Shanghai, China, 200000
- Recruiting
- Shanghai Zhongshan Hospital
-
Contact:
- Zhanggang Xue, Doctor
- Phone Number: 13601914601
- Email: xuezgang@yahoo.com.cn
-
-
Sichuan
-
Chengdu, Sichuan, China, 610000
- Recruiting
- West China Hospital, Sichuan University
-
Contact:
- Bin Liu, Doctor
- Phone Number: +86 13808186401
- Email: benbinliu@yahoo.com.cn
-
-
Tianjin
-
Tianjin, Tianjin, China, 300000
- Recruiting
- Tianjin Medical University General Hospital
-
Contact:
- Guolin Wang, Doctor
- Phone Number: +86 15822855556
- Email: wang_guolin@hotmail.com
-
-
Xinjiang
-
Urumchi, Xinjiang, China, 830000
- Withdrawn
- The First Teaching Hospital of Xinjiang Medical University
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310000
- Recruiting
- The First Affiliated Hospital of College of Medicine, Zhejiang University
-
Contact:
- Shenmei Zhu, Doctor
- Phone Number: 13857169801
- Email: smzhu20088@yahoo.com.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
Administrative protocol of Vecuronium Bromide is determined by each caregiver's clinical experience.
Other Names:
|
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.
|
Administrative protocol of cisatracurium is determined by each caregiver's clinical experience
Other Names:
|
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.
|
Administrative protocol of rocuronium is determined by each caregiver's clinical experience.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
From tracheal extubation to 1 minute after extubation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
One minute after arriving at PACU
|
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.
|
From tracheal extubation to 1 minute after extubation
|
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
|
One minute after arriving at PACU
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
any sign of residual curarization (listed in description below)
Time Frame: First 24h after surgery
|
Sign of residual curarization :
|
First 24h after surgery
|
pulmonary complications (See description)
Time Frame: participants will be followed for the duration of hospital stay, an expected average of one week
|
pulmonary complications
|
participants will be followed for the duration of hospital stay, an expected average of one week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Xinmin Wu, Doctor, Peking University First Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cammu G, De Witte J, De Veylder J, Byttebier G, Vandeput D, Foubert L, Vandenbroucke G, Deloof T. Postoperative residual paralysis in outpatients versus inpatients. Anesth Analg. 2006 Feb;102(2):426-9. doi: 10.1213/01.ane.0000195543.61123.1f.
- Debaene B, Plaud B, Dilly MP, Donati F. Residual paralysis in the PACU after a single intubating dose of nondepolarizing muscle relaxant with an intermediate duration of action. Anesthesiology. 2003 May;98(5):1042-8. doi: 10.1097/00000542-200305000-00004.
- Naguib M, Kopman AF, Ensor JE. Neuromuscular monitoring and postoperative residual curarisation: a meta-analysis. Br J Anaesth. 2007 Mar;98(3):302-16. doi: 10.1093/bja/ael386.
- Naguib M, Kopman AF, Lien CA, Hunter JM, Lopez A, Brull SJ. A survey of current management of neuromuscular block in the United States and Europe. Anesth Analg. 2010 Jul;111(1):110-9. doi: 10.1213/ANE.0b013e3181c07428. Epub 2009 Nov 12.
- Hayes AH, Mirakhur RK, Breslin DS, Reid JE, McCourt KC. Postoperative residual block after intermediate-acting neuromuscular blocking drugs. Anaesthesia. 2001 Apr;56(4):312-8. doi: 10.1046/j.1365-2044.2001.01921.x.
- Baillard C, Clec'h C, Catineau J, Salhi F, Gehan G, Cupa M, Samama CM. Postoperative residual neuromuscular block: a survey of management. Br J Anaesth. 2005 Nov;95(5):622-6. doi: 10.1093/bja/aei240. Epub 2005 Sep 23.
- Cammu G, de Baerdemaeker L, den Blauwen N, de Mey JC, Struys M, Mortier E. Postoperative residual curarization with cisatracurium and rocuronium infusions. Eur J Anaesthesiol. 2002 Feb;19(2):129-34. doi: 10.1017/s0265021502000236.
- Baillard C, Gehan G, Reboul-Marty J, Larmignat P, Samama CM, Cupa M. Residual curarization in the recovery room after vecuronium. Br J Anaesth. 2000 Mar;84(3):394-5. doi: 10.1093/oxfordjournals.bja.a013445.
- Murphy GS, Szokol JW, Marymont JH, Franklin M, Avram MJ, Vender JS. Residual paralysis at the time of tracheal extubation. Anesth Analg. 2005 Jun;100(6):1840-1845. doi: 10.1213/01.ANE.0000151159.55655.CB.
- Srivastava A, Hunter JM. Reversal of neuromuscular block. Br J Anaesth. 2009 Jul;103(1):115-29. doi: 10.1093/bja/aep093. Epub 2009 May 24. Erratum In: Br J Anaesth. 2009 Oct;103(4):622. Dosage error in article text.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Anticipated)
October 1, 2014
Study Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
September 4, 2012
First Submitted That Met QC Criteria
September 20, 2012
First Posted (Estimate)
September 21, 2012
Study Record Updates
Last Update Posted (Estimate)
May 24, 2013
Last Update Submitted That Met QC Criteria
May 22, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Delayed Emergence from Anesthesia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Antagonists
- Cholinergic Agents
- Anticonvulsants
- Neuromuscular Agents
- Nicotinic Antagonists
- Neuromuscular Nondepolarizing Agents
- Neuromuscular Blocking Agents
- Bromides
- Rocuronium
- Cisatracurium
- Vecuronium Bromide
Other Study ID Numbers
- CSA-NMB-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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