A Study of Residual Curarization Incidence in China

Perioperative/Postoperative Complications Clinical Trial

Official title:

A Perspective, Multicentre, Randomized，Blind Study of Residual Curarization Incidence in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01690338
• Other study ID #: CSA-NMB-001
• Status: Recruiting
• Phase: Phase 4
• First received: September 4, 2012
• Last updated: May 22, 2013
• Start date: October 2012
• Est. completion date: December 2014

Study information

• Verified date: May 2013
• Source: Peking University First Hospital
• Contact: Xinmin Wu, Doctor
• Phone: +86 13910616740
• Email: xmwu2784[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6090
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Perioperative/Postoperative Complications
• PORC (Postoperative Residual Curarization)
• Postoperative Complications

Intervention

Drug:
• Vecuronium Bromide
Administrative protocol of Vecuronium Bromide is determined by each caregiver's clinical experience.
• Rocuronium
Administrative protocol of rocuronium is determined by each caregiver's clinical experience.
• Cisatracurium
Administrative protocol of cisatracurium is determined by each caregiver's clinical experience

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	Xiangya Hospital of Central South University	Changsha	Hunan
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	First Affiliated Hospital, Sun Yat-Sen University	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Zhujiang Hospital Southern Medical University	Guangzhou	Guangdong
China	The First Affiliated Hospital Of College of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	Eastern Hepatobiliary Surgery Hospital	Shanghai	Shanghai
China	RenJi Hospital	Shanghai	Shanghai
China	Ruijin Hospital	Shanghai	Shanghai
China	Shanghai First People's Hospital	Shanghai	Shanghai
China	Shanghai Zhongshan Hospital	Shanghai	Shanghai
China	China Medical University Hospital	Shenyang	Liaoning
China	Hebei Medical University Fourth Hospital	Shijiazhuang	Hebei
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	The First Teaching Hospital of Xinjiang Medical University	Urumchi	Xinjiang
China	Tongji Hospital, Tongji Medical College of HUST	Wuhan	Hubei
China	Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (22)

Lead Sponsor

Collaborator

Peking University First Hospital

Central South University, China Medical University Hospital, Chinese PLA General Hospital, Eastern Hepatobiliary Surgery Hospital, First Affiliated Hospital of Zhejiang University, First Affiliated Hospital, Sun Yat-Sen University, Hebei Medical University Fourth Hospital, Peking Union Medical College Hospital, RenJi Hospital, Ruijin Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Zhongshan Hospital, The First Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of Zhengzhou University, The First Teaching Hospital of Xinjiang Medical University, Tianjin Medical University General Hospital, Tongji Hospital, West China Hospital, Wuhan Union Hospital, China, Xiangya Hospital of Central South University, Zhujiang Hospital

Country where clinical trial is conducted

China, 

References & Publications (10)

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. Epub 2005 Sep 23. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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):1840-5. — View 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. Review. — View 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. — View 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. Review. Erratum in: Br J Anaesth. 2009 Oct;103(4):622. Dosage error in article text. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	any sign of residual curarization (listed in description below)	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)	First 24h after surgery	Yes
Other	pulmonary complications (See description)	pulmonary complications; pneumonia; pulmonary atelectasis; mechanical ventilation required	participants will be followed for the duration of hospital stay, an expected average of one week	Yes
Primary	incidence of TOFr<0.9	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	Yes
Secondary	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	One minute after arriving at PACU	Yes
Secondary	Incidence of TOFr<0.7	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	Yes
Secondary	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	One minute after arriving at PACU	Yes