NCT01690338

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6,090

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2012

Typical duration for phase_4

Geographic Reach
1 country

22 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 21, 2012

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 24, 2013

Status Verified

May 1, 2013

Enrollment Period

2 years

First QC Date

September 4, 2012

Last Update Submit

May 22, 2013

Conditions

Perioperative/Postoperative ComplicationsPORC (Postoperative Residual Curarization)

Keywords

TOFr (train of four ratio)airway extubationPACU (postanesthesia care unit)PORC (postoperative residual curarization)

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Incidence of TOFr<0.9

    One minute after arriving at PACU

  • Incidence of TOFr<0.7

    From tracheal extubation to 1 minute after extubation

  • Incidence of TOFr<0.7

    One minute after arriving at PACU

Other Outcomes (2)

  • any sign of residual curarization (listed in description below)

    First 24h after surgery

  • pulmonary complications (See description)

    participants will be followed for the duration of hospital stay, an expected average of one week

Study Arms (3)

Vecuronium Bromide

ACTIVE COMPARATOR

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.

Drug: Vecuronium Bromide

cisatracurium

ACTIVE COMPARATOR

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.

Drug: Cisatracurium

rocuronium

ACTIVE COMPARATOR

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.

Drug: Rocuronium

Interventions

Vecuronium BromideDRUG

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

Also known as: Norcuron
Vecuronium Bromide
RocuroniumDRUG

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

Also known as: Esmeron
rocuronium
CisatracuriumDRUG

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

Also known as: Nimbex
cisatracurium

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

Zhujiang Hospital Southern Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

Hebei Medical University Fourth Hospital

Shijiazhuang, Hebei, 050000, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

RECRUITING

Tongji Hospital, Tongji Medical College of HUST

Wuhan, Hubei, 430000, China

RECRUITING

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

Wuhan, Hubei, 430000, China

RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

RECRUITING

China Medical University Hospital

Shenyang, Liaoning, 110000, China

RECRUITING

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

RenJi Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Ruijin Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Shanghai Zhongshan Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, 610000, China

RECRUITING

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

The First Teaching Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830000, China

WITHDRAWN

The First Affiliated Hospital Of College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (10)

  • 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.

    PMID: 16428537BACKGROUND

  • 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.

    PMID: 19910616BACKGROUND

  • 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.

    PMID: 17307778BACKGROUND

  • 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.

    PMID: 11284816BACKGROUND

  • 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.

    PMID: 16183681BACKGROUND

  • 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.

    PMID: 11999596BACKGROUND

  • 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.

    PMID: 10793602BACKGROUND

  • 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.

    PMID: 15920224BACKGROUND

  • 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.

    PMID: 12717123BACKGROUND

  • 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.

    PMID: 19468024BACKGROUND

MeSH Terms

Conditions

Postoperative ComplicationsDelayed Emergence from Anesthesia

Interventions

Vecuronium BromideRocuroniumcisatracurium

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AndrostanolsAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Xinmin Wu, Doctor

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinmin Wu, Doctor

CONTACT

+86 13910616740xmwu2784@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

September 4, 2012

First Posted

September 21, 2012

Study Start

October 1, 2012

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

May 24, 2013

Record last verified: 2013-05

Locations

CN(22)