Residual Curarization and Its Incidence at Tracheal Extubation in China

Residual Curarization Clinical Trial

— RECITE-China  

Official title:

Residual Curarization and Its Incidence at Tracheal Extubation in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01871064
• Other study ID #: LCE50498
• Status: Completed
• Phase: N/A
• First received: June 4, 2013
• Last updated: November 9, 2015
• Start date: December 2012
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1571
• Est. completion date: September 2015
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Residual Curarization

Intervention

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

Locations

Country	Name	City	State
China	Beijing Tongren Hospital	Beijing
China	Chinese PLA General Hospital	Beijing
China	Peking Union Medical College Hospital	Beijing
China	Peking University First Hospital	Beijing
China	Peking University People's Hospital	Beijing
China	Peking University Third Hospital	Beijing
China	China-Japan Union Hospital of Jilin University	Changchun	Jilin
China	Xiangya Hospital of Central South University	Changsha	Hunan
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	First Affiliated Hospital of Chongqing Medical University	Chongqing
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	ZhuJiang Hospital of Southern Medical University	Guangzhou	Guangdong
China	First Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu
China	Renji Hospital	Shanghai
China	Ruijin Hospital	Shanghai
China	Shanghai Cancer Hospital, China	Shanghai
China	Shanghai First People's Hospital	Shanghai
China	Shanghai Zhongshan Hospital	Shanghai
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	Xinjiang Traditional Chinese Medicine Hospital	Urumqi	Xinjiang
China	Second Affiliated Hospital of Wenzhou Medical College	Wenzhou	Zhejiang
China	Tongji Hospital, Tongji Medical College of HUST	Wuhan	Hubei
China	Wuhan Union Hospital	Wuhan	Hubei
China	Xijing Hospital	Xi'an	Shanxi
China	Northern Jiangsu Province People's Hospital	Yangzhou	Jiangsu
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Xinmin Wu	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

China, 

References & Publications (13)

Aldrete JA. The post-anesthesia recovery score revisited. J Clin Anesth. 1995 Feb;7(1):89-91. — View Citation

Apfel CC, Läärä 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. — View Citation

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. — 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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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, table of contents. — 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

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percentage of Participants With Residual NMB (TOF Ratio <0.9) Upon Arrival to the Post-anesthesia Care Unit (PACU)	Neuromuscular functioning was monitored at time of PACU arrival 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 upon PACU arrival	No
Secondary	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	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	Immediately prior to tracheal extubation in the OR	No
Secondary	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	Neuromuscular functioning was monitored at time of PACU arrival 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.	Immediately upon PACU Arrival	No