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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TOF-Watch SX® Monitoring of NMB | Device | Participants will have the extent of NMB monitored by a TOF-Watch SX®. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Xinmin Wu, MD | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong | China | |||
| The First Affiliated Hospital, Sun Yat-sen University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7772368 | Background | 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. | |
| 14693617 | Background | 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. |
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| 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 | 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 |
| 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 |
| Guangzhou |
| Guangdong |
| China |
| ZhuJiang Hospital of Southern Medical University | Guangzhou | Guangdong | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China |
| Tongji Hospital, Tongji Medical College of HUST | Wuhan | Hubei | China |
| Wuhan Union Hospital | Wuhan | Hubei | China |
| Xiangya Hospital of Central South University | Changsha | Hunan | China |
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Nanjing | Jiangsu | China |
| Northern Jiangsu Province People's Hospital | Yangzhou | Jiangsu | China |
| China-Japan Union Hospital of Jilin University | Changchun | Jilin | China |
| The First Hospital of China Medical University | Shenyang | Liaoning | China |
| Qilu Hospital of Shandong University | Jinan | Shandong | China |
| Xijing Hospital | Xi’an | Shanxi | China |
| West China Hospital, Sichuan University | Chengdu | Sichuan | China |
| Xinjiang Traditional Chinese Medicine Hospital | Ürümqi | Xinjiang | 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 |
| Second Affiliated Hospital of Wenzhou Medical College | Wenzhou | Zhejiang | China |
| Peking University First Hospital | Beijing | 100034 | China |
| Beijing Tongren Hospital | Beijing | China |
| Chinese PLA General Hospital | Beijing | China |
| Peking Union Medical College Hospital | Beijing | China |
| Peking University People's Hospital | Beijing | China |
| Peking University Third Hospital | Beijing | China |
| First Affiliated Hospital of Chongqing Medical University | Chongqing | 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 |
| 10485781 | 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. |
| 20442260 | 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. |
| 15920224 | 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. |
| 10418647 | 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. |
| 12717123 | 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. |
| 9105219 | 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. |
| 11072806 | 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. |
| 10754616 | 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. |
| 9366453 | 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. |
| 20601860 | 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. |
| 17635389 | 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. |
| 26452561 | Derived | 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. |