Residual Curarization and Its Incidence at Tracheal Extubation in China

NCT01871064 | Completed DMC

• 1 other identifier: LCE50498
• Study Type: observational
• Target: 1,571
• Locations: 1 country
• Sites: 32

Brief Summary

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.

Conditions

Residual Curarization

Keywords

Laparotomy; laparoscopic surgery; general anesthesia; Neuromuscular Block

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Residual Neuromuscular Blockade (NMB)(Train of Four [TOF] Ratio <0.9) at Time of Tracheal Extubation

  Neuromuscular functioning was monitored at time of tracheal extubation by applying three TOF electrical stimulations to the ulnar nerve and assessing twitch response at the adductor pollices muscle. T1 and T4 refer to the magnitudes (height) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 Ratio (expressed as a decimal of up to 1.0) indicates the extent of recovery from NMB, with a higher ratio indicating greater recovery from NMB. A T4/T1 Ratio of \<0.9 is indicative of residual NMB.

  Immediately prior to tracheal extubation in the OR

Secondary Outcomes (3)

• Percentage of Participants With Residual NMB (TOF Ratio <0.9) Upon Arrival to the Post-anesthesia Care Unit (PACU)

  Immediately upon PACU arrival

• Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥0.6 to <0.7, ≥0.7 to <0.8, ≥0.8 to <0.9) at Tracheal Extubation

  Immediately prior to tracheal extubation in the OR

• Percentage of Participants With Residual NMB at Various TOF Ratios (<0.6, ≥ 0.6 to <0.7, ≥ 0.7 to <0.8, ≥0.8 to <0.9) Upon Arrival to the PACU

  Immediately upon PACU Arrival

Interventions

TOF-Watch SX® Monitoring of NMB DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults 18 years of age or older scheduled to undergo an elective open abdominal or laparoscopic surgical procedure for an anticipated duration of less than four hours will be approached for participation in the study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinmin Wu: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (32)

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Location

ZhuJiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Tongji Hospital, Tongji Medical College of HUST

Wuhan, Hubei, China

Location

Wuhan Union Hospital

Wuhan, Hubei, China

Location

Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Location

Northern Jiangsu Province People's Hospital

Yangzhou, Jiangsu, China

Location

China-Japan Union Hospital of Jilin University

Changchun, Jilin, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, China

Location

Xijing Hospital

Xi’an, Shanxi, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Location

Xinjiang Traditional Chinese Medicine Hospital

Ürümqi, Xinjiang, China

Location

First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Location

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Location

Second Affiliated Hospital of Wenzhou Medical College

Wenzhou, Zhejiang, China

Location

Peking University First Hospital

Beijing, 100034, China

Location

Beijing Tongren Hospital

Beijing, China

Location

Chinese PLA General Hospital

Beijing, China

Location

Peking Union Medical College Hospital

Beijing, China

Location

Peking University People's Hospital

Beijing, China

Location

Peking University Third Hospital

Beijing, China

Location

First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Location

Renji Hospital

Shanghai, China

Location

Ruijin Hospital

Shanghai, China

Location

Shanghai Cancer Hospital, China

Shanghai, China

Location

Shanghai First People's Hospital

Shanghai, China

Location

Shanghai Zhongshan Hospital

Shanghai, China

Location

Related Publications (14)

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• 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.

  PMID: 14693617 BACKGROUND

• 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.

  PMID: 10485781 BACKGROUND

• 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.

  PMID: 20442260 BACKGROUND

• 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: 15920224 BACKGROUND

• 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.

  PMID: 10418647 BACKGROUND

• 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: 12717123 BACKGROUND

• 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.

  PMID: 9105219 BACKGROUND

• 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.

  PMID: 11072806 BACKGROUND

• 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.

  PMID: 10754616 BACKGROUND

• 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.

  PMID: 9366453 BACKGROUND

• 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.

  PMID: 20601860 BACKGROUND

• 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.

  PMID: 17635389 BACKGROUND

• 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.

  PMID: 26452561 DERIVED

Study Officials

• Xinmin Wu, MD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 6, 2013
• Study Start: December 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2015
• Last Updated: November 10, 2015

Record last verified: 2015-11

Locations

CN (32)