Back to resultsA Study of Residual Curarization Incidence in China
Primary Purpose
Perioperative/Postoperative Complications, PORC (Postoperative Residual Curarization)
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Vecuronium Bromide
Rocuronium
Cisatracurium
Sponsored by
About this trial
This is an interventional treatment trial for Perioperative/Postoperative Complications focused on measuring TOFr (train of four ratio), airway extubation, PACU (postanesthesia care unit), PORC (postoperative residual curarization)
Eligibility 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
Sites / Locations
- Chinese PLA General HospitalRecruiting
- Peking Union Medical College HospitalRecruiting
- Peking University First HospitalRecruiting
- First Affiliated Hospital, Sun Yat-Sen UniversityRecruiting
- The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting
- Zhujiang Hospital Southern Medical UniversityRecruiting
- Hebei Medical University Fourth HospitalRecruiting
- The First Affiliated Hospital of Zhengzhou UniversityRecruiting
- Tongji Hospital, Tongji Medical College of HUSTRecruiting
- Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
- The Second Xiangya Hospital of Central South UniversityRecruiting
- Xiangya Hospital of Central South UniversityRecruiting
- China Medical University HospitalRecruiting
- Eastern Hepatobiliary Surgery HospitalRecruiting
- RenJi HospitalRecruiting
- Ruijin HospitalRecruiting
- Shanghai First People's HospitalRecruiting
- Shanghai Zhongshan HospitalRecruiting
- West China Hospital, Sichuan UniversityRecruiting
- Tianjin Medical University General HospitalRecruiting
- The First Teaching Hospital of Xinjiang Medical University
- The First Affiliated Hospital Of College of Medicine, Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Vecuronium Bromide
cisatracurium
rocuronium
Arm 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.
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.
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.
Outcomes
Primary Outcome Measures
incidence of TOFr<0.9
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
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
Once tracheal extubation is performed after the surgery is over, monitor the neuromuscular transmission function (TOF ratio) immediately.
Incidence of TOFr<0.7
When patients arrive at PACU(an expected average of 15 minutes after surgery is over), monitor the neuromuscular transmission function (TOF ratio) immediately
Full Information
NCT ID
NCT01690338
First Posted
September 4, 2012
Last Updated
May 22, 2013
Sponsor
Peking University First Hospital
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
1. Study Identification
Unique Protocol Identification Number
NCT01690338
Brief Title
A Study of Residual Curarization Incidence in China
Official Title
A Perspective, Multicentre, Randomized，Blind Study of Residual Curarization Incidence in China
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital
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
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perioperative/Postoperative Complications, PORC (Postoperative Residual Curarization)
Keywords
TOFr (train of four ratio), airway extubation, PACU (postanesthesia care unit), PORC (postoperative residual curarization)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
6090 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vecuronium Bromide
Arm Type
Active Comparator
Arm 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.
Arm Title
cisatracurium
Arm Type
Active Comparator
Arm 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.
Arm Title
rocuronium
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Vecuronium Bromide
Other Intervention Name(s)
Norcuron
Intervention Description
Administrative protocol of Vecuronium Bromide is determined by each caregiver's clinical experience.
Intervention Type
Drug
Intervention Name(s)
Rocuronium
Other Intervention Name(s)
Esmeron
Intervention Description
Administrative protocol of rocuronium is determined by each caregiver's clinical experience.
Intervention Type
Drug
Intervention Name(s)
Cisatracurium
Other Intervention Name(s)
Nimbex
Intervention Description
Administrative protocol of cisatracurium is determined by each caregiver's clinical experience
Primary Outcome Measure Information:
Title
incidence of TOFr<0.9
Description
Once tracheal extubation is performed after the surgery is over, monitor the neuromuscular transmission function (TOF ratio) immediately.
Time Frame
From tracheal extubation to 1 minute after extubation
Secondary Outcome Measure Information:
Title
Incidence of TOFr<0.9
Description
When patients arrive at PACU(an expected average of 15 minutes after surgery is over), monitor the neuromuscular transmission function (TOF ratio) immediately
Time Frame
One minute after arriving at PACU
Title
Incidence of TOFr<0.7
Description
Once tracheal extubation is performed after the surgery is over, monitor the neuromuscular transmission function (TOF ratio) immediately.
Time Frame
From tracheal extubation to 1 minute after extubation
Title
Incidence of TOFr<0.7
Description
When patients arrive at PACU(an expected average of 15 minutes after surgery is over), monitor the neuromuscular transmission function (TOF ratio) immediately
Time Frame
One minute after arriving at PACU
Other Pre-specified Outcome Measures:
Title
any sign of residual curarization (listed in description below)
Description
Sign of residual curarization :
dyspnea
weak hand-grip force
Head lift or leg lift time shorter than 5s
aspiration
respiratory rate >20/min
hypoxemia (SpO2<90% when O2>3L/min)
Time Frame
First 24h after surgery
Title
pulmonary complications (See description)
Description
pulmonary complications
pneumonia
pulmonary atelectasis
mechanical ventilation required
Time Frame
participants will be followed for the duration of hospital stay, an expected average of one week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xinmin Wu, Doctor
Phone
+86 13910616740
Email
xmwu2784@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xinmin Wu, Doctor
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weidong Mi, Doctor
Phone
+86 13381082966
Email
wwdd1962@yahoo.com.cn
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing Zhao, Doctor
Phone
+86 13901048114
Email
Zhaojing1009@yahoo.com.cn
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuan Zeng, Doctor
Phone
+86 13520703600
Email
yuan_zeng@sina.com
First Name & Middle Initial & Last Name & Degree
Yuan Zeng, Doctor
Facility Name
First Affiliated Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenqi Huang, Doctor
Phone
+86 13802963182
Email
huangwenqi86@yahoo.com.cn
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qinglong Dong, Doctor
Phone
13602837397
Email
qldong@163.net
Facility Name
Zhujiang Hospital Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiyuan Xu, Doctor
Phone
+86 13609727860
Email
xushiyuan355@yahoo.com.cn
Facility Name
Hebei Medical University Fourth Hospital
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zixian Song, Doctor
Phone
+86 13400312688
Email
zixiansong@126.com
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Zhang, Doctor
Phone
+86 13673996966
Email
Zhangw571012@126.com
Facility Name
Tongji Hospital, Tongji Medical College of HUST
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ailin Luo, Doctor
Phone
+86 13507122565
Email
ailinluo@yahoo.cn
Facility Name
Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingping Wu, Doctor
Phone
+86 13971605283
Email
Wqp1968@163.com
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junmei Xu, Doctor
Phone
+86 13975148864
Email
13975148864@139.com
Facility Name
Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qulian Guo, Doctor
Phone
+86 13707315866
Email
qulianguo@hotmail.com
Facility Name
China Medical University Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Ma, Doctor
Phone
+86 13840366406
Email
mahong5466@yahoo.com
Facility Name
Eastern Hepatobiliary Surgery Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weifeng Yu, Doctor
Phone
+86 13901961704
Email
Ywf808@yeah.net
Facility Name
RenJi Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangrui Wang, Doctor
Phone
13701901953
Email
xiangrui68@163.com
Facility Name
Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qingsheng Xue, Doctor
Phone
+86 13611909814
Email
xueqingsheng@yahoo.com.cn
Facility Name
Shanghai First People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingtian Wang, Doctor
Phone
+86 13386259639
Email
wang_didi26@yahoo.com.cn
Facility Name
Shanghai Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhanggang Xue, Doctor
Phone
13601914601
Email
xuezgang@yahoo.com.cn
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Liu, Doctor
Phone
+86 13808186401
Email
benbinliu@yahoo.com.cn
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guolin Wang, Doctor
Phone
+86 15822855556
Email
wang_guolin@hotmail.com
Facility Name
The First Teaching Hospital of Xinjiang Medical University
City
Urumchi
State/Province
Xinjiang
ZIP/Postal Code
830000
Country
China
Individual Site Status
Withdrawn
Facility Name
The First Affiliated Hospital Of College of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shenmei Zhu, Doctor
Phone
13857169801
Email
smzhu20088@yahoo.com.cn
12. IPD Sharing Statement
Citations:
PubMed Identifier
16428537
Citation
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.
Results Reference
background
PubMed Identifier
19910616
Citation
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.
Results Reference
background
PubMed Identifier
17307778
Citation
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.
Results Reference
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PubMed Identifier
11284816
Citation
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.
Results Reference
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PubMed Identifier
16183681
Citation
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.
Results Reference
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PubMed Identifier
11999596
Citation
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.
Results Reference
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PubMed Identifier
10793602
Citation
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.
Results Reference
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PubMed Identifier
15920224
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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A Study of Residual Curarization Incidence in China
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