Clinical trial NCT01690338: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Perioperative/Postoperative Complications
PORC (Postoperative Residual Curarization)
Keywords: TOFr (train of four ratio)
airway extubation
PACU (postanesthesia care unit)
PORC (postoperative residual curarization)
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Ruijin Hospital
name: RenJi Hospital
name: Shanghai Zhongshan Hospital
name: The First Affiliated Hospital of Guangzhou Medical University
name: West China Hospital
name: Eastern Hepatobiliary Surgery Hospital
name: Wuhan Union Hospital, China
name: Zhujiang Hospital
name: Chinese PLA General Hospital
name: First Affiliated Hospital, Sun Yat-Sen University
name: The First Affiliated Hospital of Zhengzhou University
name: Tianjin Medical University General Hospital
name: Xiangya Hospital of Central South University
name: Central South University
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: First Affiliated Hospital of Xinjiang Medical University
name: Peking Union Medical College Hospital
name: First Affiliated Hospital of Zhejiang University
name: China Medical University Hospital
name: Hebei Medical University Fourth Hospital
name: Tongji Hospital
First posted: 2012-09-21
Enrollment: 6090
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: incidence of TOFr<0.9
timeFrame: From tracheal extubation to 1 minute after extubation
Secondary outcomes:
measure: Incidence of TOFr<0.9
timeFrame: One minute after arriving at PACU
measure: Incidence of TOFr<0.7
timeFrame: From tracheal extubation to 1 minute after extubation
measure: Incidence of TOFr<0.7
timeFrame: One minute after arriving at PACU
Other outcomes:
measure: any sign of residual curarization (listed in description below)
timeFrame: First 24h after surgery
measure: pulmonary complications (See description)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of one week
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Guangzhou
country: China
facility: First Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Zhujiang Hospital Southern Medical University
state: Guangdong
city: Shijiazhuang
country: China
facility: Hebei Medical University Fourth Hospital
state: Hebei
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College of HUST
state: Hubei
city: Wuhan
country: China
facility: Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
city: Shenyang
country: China
facility: China Medical University Hospital
state: Liaoning
city: Shanghai
country: China
facility: Eastern Hepatobiliary Surgery Hospital
state: Shanghai
city: Shanghai
country: China
facility: RenJi Hospital
state: Shanghai
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai First People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Urumchi
country: China
facility: The First Teaching Hospital of Xinjiang Medical University
state: Xinjiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital Of College of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Peking University First Hospital
name: Xinmin Wu, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.