Residual Curarization and Its Incidence at Tracheal Extubation in China

NCT ID: NCT01871064

Last Updated: 2015-11-10

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

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Recruitment Status

COMPLETED

Total Enrollment

1571 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-09-30

Brief Summary

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This study will assess the residual neuromuscular blockade (NMB) Train-Of-Four (TOF) ratios at tracheal extubation when anesthesiologists have determined that full recovery of neuromuscular function has occurred using standard clinical criteria for participants whose non-depolarizing-induced NMB is either not reversed or reversed with an acetylcholinesterase inhibitor administered as per standard routine care.

Detailed Description

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This is a prospective, multi-site, anesthesiologist and PACU nurse TOF-Watch SX® blinded observational study of surgical patients undergoing elective laparoscopic or open abdominal procedures requiring general anesthesia and non-depolarizing neuromuscular blockade. There are two temporal aspects to the data collection: a prospective data collection in the OR and PACU; and a retrospective chart review one week after hospital discharge.

Conditions

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Residual Curarization

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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TOF-Watch SX® Monitoring of NMB

Participants will have the extent of NMB monitored by a TOF-Watch SX®.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age≥18;
* American Society of Anesthesiologists(ASA) class 1-3;
* Scheduled for elective open or laparoscopic abdominal surgery that is anticipated to last less than 4 hours;
* Administration of general anesthesia and ≥ 1 dose of non-depolarizing neuromuscular blockers for endotracheal intubation or maintenance of neuromuscular blockade;
* Planned for extubation to occur in the OR;
* Signed informed consent.

Exclusion Criteria

* Redo surgery on the same hospital admission;
* Pre-established need or expected to require post-operative mechanical ventilation;
* Conditions, surgical procedures, or participant positioning that may interfere with TOF-Watch SX® operation, calibration, or accuracy;
* Anesthesiologist use of objective neuromuscular monitoring during surgery (e.g. mechanomyography, electromyography or related method);
* Pregnancy;
* Participation in any other clinical trial;
* Member or a family member of the personnel of the investigational or Sponsor staff directly involved with this trial.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Xinmin Wu

OTHER

Sponsor Role lead

Responsible Party

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Xinmin Wu

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Xinmin Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

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Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

ZhuJiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status

Tongji Hospital, Tongji Medical College of HUST

Wuhan, Hubei, China

Site Status

Wuhan Union Hospital

Wuhan, Hubei, China

Site Status

Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Site Status

Northern Jiangsu Province People's Hospital

Yangzhou, Jiangsu, China

Site Status

China-Japan Union Hospital of Jilin University

Changchun, Jilin, China

Site Status

The First Hospital of China Medical University

Shenyang, Liaoning, China

Site Status

Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status

Xijing Hospital

Xi’an, Shanxi, China

Site Status

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status

Xinjiang Traditional Chinese Medicine Hospital

Ürümqi, Xinjiang, China

Site Status

First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Site Status

Second Affiliated Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, China

Site Status

Peking University First Hospital

Beijing, , China

Site Status

Beijing Tongren Hospital

Beijing, , China

Site Status

Chinese PLA General Hospital

Beijing, , China

Site Status

Peking Union Medical College Hospital

Beijing, , China

Site Status

Peking University People's Hospital

Beijing, , China

Site Status

Peking University Third Hospital

Beijing, , China

Site Status

First Affiliated Hospital of Chongqing Medical University

Chongqing, , China

Site Status

Renji Hospital

Shanghai, , China

Site Status

Ruijin Hospital

Shanghai, , China

Site Status

Shanghai Cancer Hospital, China

Shanghai, , China

Site Status

Shanghai First People's Hospital

Shanghai, , China

Site Status

Shanghai Zhongshan Hospital

Shanghai, , China

Site Status

Countries

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China

References

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Aldrete JA. The post-anesthesia recovery score revisited. J Clin Anesth. 1995 Feb;7(1):89-91. doi: 10.1016/0952-8180(94)00001-k. No abstract available.

Reference Type BACKGROUND
PMID: 7772368 (View on PubMed)

Murphy GS, Szokol JW, Franklin M, Marymont JH, Avram MJ, Vender JS. Postanesthesia care unit recovery times and neuromuscular blocking drugs: a prospective study of orthopedic surgical patients randomized to receive pancuronium or rocuronium. Anesth Analg. 2004 Jan;98(1):193-200. doi: 10.1213/01.ANE.0000095040.36648.F7.

Reference Type BACKGROUND
PMID: 14693617 (View on PubMed)

Apfel CC, Laara E, Koivuranta M, Greim CA, Roewer N. A simplified risk score for predicting postoperative nausea and vomiting: conclusions from cross-validations between two centers. Anesthesiology. 1999 Sep;91(3):693-700. doi: 10.1097/00000542-199909000-00022.

Reference Type BACKGROUND
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Murphy GS, Brull SJ. Residual neuromuscular block: lessons unlearned. Part I: definitions, incidence, and adverse physiologic effects of residual neuromuscular block. Anesth Analg. 2010 Jul;111(1):120-8. doi: 10.1213/ANE.0b013e3181da832d. Epub 2010 May 4.

Reference Type BACKGROUND
PMID: 20442260 (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)

Fezing AK, d'Hollander A, Boogaerts JG. Assessment of the postoperative residual curarisation using the train of four stimulation with acceleromyography. Acta Anaesthesiol Belg. 1999;50(2):83-6.

Reference Type BACKGROUND
PMID: 10418647 (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)

Kopman AF, Yee PS, Neuman GG. Relationship of the train-of-four fade ratio to clinical signs and symptoms of residual paralysis in awake volunteers. Anesthesiology. 1997 Apr;86(4):765-71. doi: 10.1097/00000542-199704000-00005.

Reference Type BACKGROUND
PMID: 9105219 (View on PubMed)

Bissinger U, Schimek F, Lenz G. Postoperative residual paralysis and respiratory status: a comparative study of pancuronium and vecuronium. Physiol Res. 2000;49(4):455-62.

Reference Type BACKGROUND
PMID: 11072806 (View on PubMed)

Sundman E, Witt H, Olsson R, Ekberg O, Kuylenstierna R, Eriksson LI. The incidence and mechanisms of pharyngeal and upper esophageal dysfunction in partially paralyzed humans: pharyngeal videoradiography and simultaneous manometry after atracurium. Anesthesiology. 2000 Apr;92(4):977-84. doi: 10.1097/00000542-200004000-00014.

Reference Type BACKGROUND
PMID: 10754616 (View on PubMed)

Eriksson LI, Sundman E, Olsson R, Nilsson L, Witt H, Ekberg O, Kuylenstierna R. Functional assessment of the pharynx at rest and during swallowing in partially paralyzed humans: simultaneous videomanometry and mechanomyography of awake human volunteers. Anesthesiology. 1997 Nov;87(5):1035-43. doi: 10.1097/00000542-199711000-00005.

Reference Type BACKGROUND
PMID: 9366453 (View on PubMed)

Royse CF, Newman S, Chung F, Stygall J, McKay RE, Boldt J, Servin FS, Hurtado I, Hannallah R, Yu B, Wilkinson DJ. Development and feasibility of a scale to assess postoperative recovery: the post-operative quality recovery scale. Anesthesiology. 2010 Oct;113(4):892-905. doi: 10.1097/ALN.0b013e3181d960a9.

Reference Type BACKGROUND
PMID: 20601860 (View on PubMed)

Fuchs-Buder T, Claudius C, Skovgaard LT, Eriksson LI, Mirakhur RK, Viby-Mogensen J; 8th International Neuromuscular Meeting. Good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II: the Stockholm revision. Acta Anaesthesiol Scand. 2007 Aug;51(7):789-808. doi: 10.1111/j.1399-6576.2007.01352.x.

Reference Type BACKGROUND
PMID: 17635389 (View on PubMed)

Yu B, Ouyang B, Ge S, Luo Y, Li J, Ni D, Hu S, Xu H, Liu J, Min S, Li L, Ma Z, Xie K, Miao C, Wu X; RECITE-China Investigators. Incidence of postoperative residual neuromuscular blockade after general anesthesia: a prospective, multicenter, anesthetist-blind, observational study. Curr Med Res Opin. 2016;32(1):1-9. doi: 10.1185/03007995.2015.1103213. Epub 2015 Nov 11.

Reference Type DERIVED
PMID: 26452561 (View on PubMed)

Other Identifiers

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LCE50498

Identifier Type: -

Identifier Source: org_study_id

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