A Study of Residual Curarization Incidence in China

NCT ID: NCT01690338

Last Updated: 2013-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

6090 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Perioperative/Postoperative Complications PORC (Postoperative Residual Curarization)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Vecuronium Bromide

Intervention Type DRUG

Administrative protocol of Vecuronium Bromide is determined by each caregiver's clinical experience.

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.

Group Type ACTIVE_COMPARATOR

Cisatracurium

Intervention Type DRUG

Administrative protocol of cisatracurium is determined by each caregiver's clinical experience

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.

Group Type ACTIVE_COMPARATOR

Rocuronium

Intervention Type DRUG

Administrative protocol of rocuronium is determined by each caregiver's clinical experience.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vecuronium Bromide

Administrative protocol of Vecuronium Bromide is determined by each caregiver's clinical experience.

Intervention Type DRUG

Rocuronium

Administrative protocol of rocuronium is determined by each caregiver's clinical experience.

Intervention Type DRUG

Cisatracurium

Administrative protocol of cisatracurium is determined by each caregiver's clinical experience

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Norcuron Esmeron Nimbex

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ruijin Hospital

OTHER

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role collaborator

Shanghai Zhongshan Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role collaborator

Eastern Hepatobiliary Surgery Hospital

OTHER

Sponsor Role collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role collaborator

Zhujiang Hospital

OTHER

Sponsor Role collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Tianjin Medical University General Hospital

OTHER

Sponsor Role collaborator

Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

Central South University

OTHER

Sponsor Role collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Xinjiang Medical University

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role collaborator

China Medical University Hospital

OTHER

Sponsor Role collaborator

Hebei Medical University Fourth Hospital

OTHER

Sponsor Role collaborator

Tongji Hospital

OTHER

Sponsor Role collaborator

Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Xinmin Wu

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Xinmin Wu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Zhujiang Hospital Southern Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Hebei Medical University Fourth Hospital

Shijiazhuang, Hebei, China

Site Status RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status RECRUITING

Tongji Hospital, Tongji Medical College of HUST

Wuhan, Hubei, China

Site Status RECRUITING

Wuhan Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status RECRUITING

China Medical University Hospital

Shenyang, Liaoning, China

Site Status RECRUITING

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

RenJi Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status RECRUITING

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

The First Teaching Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Site Status WITHDRAWN

The First Affiliated Hospital Of College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Xinmin Wu, Doctor

Role: CONTACT

+86 13910616740

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Weidong Mi, Doctor

Role: primary

+86 13381082966

Jing Zhao, Doctor

Role: primary

+86 13901048114

Yuan Zeng, Doctor

Role: primary

+86 13520703600

Wenqi Huang, Doctor

Role: primary

+86 13802963182

Qinglong Dong, Doctor

Role: primary

13602837397

Shiyuan Xu, Doctor

Role: primary

+86 13609727860

Zixian Song, Doctor

Role: primary

+86 13400312688

Wei Zhang, Doctor

Role: primary

+86 13673996966

Ailin Luo, Doctor

Role: primary

+86 13507122565

Qingping Wu, Doctor

Role: primary

+86 13971605283

Junmei Xu, Doctor

Role: primary

+86 13975148864

Qulian Guo, Doctor

Role: primary

+86 13707315866

Hong Ma, Doctor

Role: primary

+86 13840366406

Weifeng Yu, Doctor

Role: primary

+86 13901961704

Xiangrui Wang, Doctor

Role: primary

13701901953

Qingsheng Xue, Doctor

Role: primary

+86 13611909814

Yingtian Wang, Doctor

Role: primary

+86 13386259639

Zhanggang Xue, Doctor

Role: primary

13601914601

Bin Liu, Doctor

Role: primary

+86 13808186401

Guolin Wang, Doctor

Role: primary

+86 15822855556

Shenmei Zhu, Doctor

Role: primary

13857169801

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 16428537 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19910616 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17307778 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11284816 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16183681 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11999596 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10793602 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15920224 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12717123 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19468024 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CSA-NMB-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.