Anesthesia Clinical Trial
— CRCOfficial title:
Optimal Dose of Combination of Rocuronium and Cisatracurium: A Randomized Double-blinded Clinical Trial
Verified date | January 2018 |
Source | Yonsei University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
BACKGROUND: The combinations of rocuronium and cisatracurium have a synergic effect. The
investigators studied whether the prediction is possible to have a sufficient effect of
reducing the dose when combining the two neuromuscular blocking agents through monitoring
neuromuscular relaxation during surgery.
METHODS: Each group were intubating dose group (Group I, n=27) combined Effective Dose (ED)95
rocuronium and ED95 cisatracurium, small amount reducing group (Group S, n=27) reduced 10% of
each ED95 and large amount reducing group (Group L, n=27) reduced 20% of each ED95. Before
patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse
who was not involved in this study. Each study drug was administrated to the patient and
timer was started with TOF-Watch® monitoring. Train-of-four (TOF) of the ulnar nerve was used
as setting of 2 Hz per 12 sec. The investigators checked time to TOF ratio=0 (Onset), time to
1st TOF ratio>25% (Duration 25%) and TOF 25-75% (recovery index) under total i.v. anesthesia
(TIVA). One way ANOVA was used for statistical analysis (α=0.05, β=0.2).
Status | Completed |
Enrollment | 81 |
Est. completion date | February 2015 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 60 Years |
Eligibility |
Inclusion Criteria: - the American Society of Anesthesiologists (ASA) physical status I-II - BMI 20-30 kg/m2 - Patients scheduled for mastoidectomy and tympanoplasty. Exclusion Criteria: - a history of allergy to the study drugs, - neuromuscular disease, - pregnancy - breast-feeding, - preoperative medication of antipsychotics or neuroleptics known to interact with NMBAs - serum creatinine level>1.2 mg/dL, - liver transaminase>40 U/L. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
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Amin AM, Mohammad MY, Ibrahim MF. Comparative study of neuromuscular blocking and hemodynamic effects of rocuronium and cisatracurium under sevoflurane or total intravenous anesthesia. Middle East J Anaesthesiol. 2009 Feb;20(1):39-51. — View Citation
Breslin DS, Jiao K, Habib AS, Schultz J, Gan TJ. Pharmacodynamic interactions between cisatracurium and rocuronium. Anesth Analg. 2004 Jan;98(1):107-10, table of contents. — View Citation
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. — View Citation
de Morais BS, de Castro CH, Teixeira VC, Pinto AS. Residual neuromuscular block after rocuronium or cisatracurium. Rev Bras Anestesiol. 2005 Dec;55(6):622-30. English, Portuguese. — View Citation
Donati F, Plaud B. Rocuronium-cisatracurium combinations. Anesthesiology. 1999 Aug;91(2):587-8. — View Citation
Fassbender P, Geldner G, Blobner M, Hofmockel R, Rex C, Gautam S, Malhotra A, Eikermann M. Clinical predictors of duration of action of cisatracurium and rocuronium administered long-term. Am J Crit Care. 2009 Sep;18(5):439-45. doi: 10.4037/ajcc2009883. — View Citation
Flockton EA, Mastronardi P, Hunter JM, Gomar C, Mirakhur RK, Aguilera L, Giunta FG, Meistelman C, Prins ME. Reversal of rocuronium-induced neuromuscular block with sugammadex is faster than reversal of cisatracurium-induced block with neostigmine. Br J Anaesth. 2008 May;100(5):622-30. doi: 10.1093/bja/aen037. Epub 2008 Apr 2. — View Citation
Hans P, Welter P, Dewandre PY, Brichant JF, Bonhomme V. Recovery from neuromuscular block after an intubation dose of cisatracurium and rocuronium in lumbar disc surgery. Acta Anaesthesiol Belg. 2004;55(2):129-33. — View Citation
Kim KS, Chun YS, Chon SU, Suh JK. Neuromuscular interaction between cisatracurium and mivacurium, atracurium, vecuronium or rocuronium administered in combination. Anaesthesia. 1998 Sep;53(9):872-8. — View Citation
Kopman AF, Kopman DJ, Ng J, Zank LM. Antagonism of profound cisatracurium and rocuronium block: the role of objective assessment of neuromuscular function. J Clin Anesth. 2005 Feb;17(1):30-5. — View Citation
Kopman AF, Zank LM, Ng J, Neuman GG. Antagonism of cisatracurium and rocuronium block at a tactile train-of-four count of 2: should quantitative assessment of neuromuscular function be mandatory? Anesth Analg. 2004 Jan;98(1):102-6, table of contents. — View Citation
Lee H, Jeong S, Choi C, Jeong H, Lee S, Jeong S. Anesthesiologist's satisfaction using between cisatracurium and rocuronium for the intubation in the anesthesia induced by remifentanil and propofol. Korean J Anesthesiol. 2013 Jan;64(1):34-9. doi: 10.4097/kjae.2013.64.1.34. Epub 2013 Jan 21. — View Citation
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Leykin Y, Pellis T, Lucca M, Lomangino G, Marzano B, Gullo A. The pharmacodynamic effects of rocuronium when dosed according to real body weight or ideal body weight in morbidly obese patients. Anesth Analg. 2004 Oct;99(4):1086-9, table of contents. — View Citation
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Lin SP, Chang KY, Chen YJ, Lin SM, Chang WK, Chan KH, Ting CK. Priming with rocuronium to accelerate the onset time of cisatracurium during intubation. J Chin Med Assoc. 2009 Jan;72(1):15-9. doi: 10.1016/S1726-4901(09)70014-0. — View Citation
Liu M, Dilger JP. Synergy between pairs of competitive antagonists at adult human muscle acetylcholine receptors. Anesth Analg. 2008 Aug;107(2):525-33. doi: 10.1213/ane.0b013e31817b4469. — View Citation
Mak PH, Irwin MG. The effect of cisatracurium and rocuronium on cisatracurium precurarization and the priming principle. J Clin Anesth. 2004 Mar;16(2):83-7. — View Citation
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Non Invasive Blood Pressure, | Before induction of anesthesia, non invasive blood pressure was measured for baseline. And after injection of NMBAs, non invasive blood pressure was measured at 10 min. |
Before and after induction of anesthesia, an average 10 min. | |
Other | Peripheral Oxygen Saturation | Before induction of anesthesia, peripheral oxygen saturation was measured for baseline. And after injection of NMBAs, peripheral oxygen saturation was measured at 10 min. |
Before and after induction of anesthesia, an average 10 min. | |
Other | Body Temperature | Before induction of anesthesia, body temperature was measured for baseline by oral temperature probe. And after injection of NMBAs, non invasive blood pressure was measured at 10 min by esophageal temperature probe. |
Before and after induction of anesthesia, an average 10 min. | |
Other | Bispectral Index | The BIS monitor provides a single dimensionless number, which ranges from 0 (equivalent to EEG silence) to 100. A BIS value between 40 and 60 indicates an appropriate level for general anesthesia, as recommended by the manufacturer. Before induction of anesthesia, bispectral index was measured for baseline. And after injection of NMBAs, bispectral index was measured at 10 min. |
Before and after induction of anesthesia, an average 10 min. | |
Primary | Onset of Neuromuscular Blocking Agents(NMBAs) | Time from administration of initial NMBAs to Train-of-four (TOF) ratio=0, assessed up to 15 minutes during general anesthesia. | Intraoperative, an average of 5 minutes | |
Primary | Duration 25% of Neuromuscular Blocking Agents(NMBAs) | Time from administration of initial NMBAs to Train-of-four (TOF) ratio >25%, assessed up to 2 hours during general anesthesia. | Intraoperative, an average of 1 hours | |
Primary | Recovery Index of Neuromuscular Blocking Agents(NMBAs) | Time from TOF ratio 25% to 75%, assessed up to 1 hour during general anesthesia. | Intraoperative, an average of 20 minutes | |
Secondary | Operation Time | Time from skin incision to wound dressing assessed up to 8 hours. | Intraoperative, an average of 3 hours. | |
Secondary | Anesthetic Time | Time from induction to recovery of anesthesia, asessed up to 3 hours. | Intraoperative, an average 4 hours. | |
Secondary | Additional Rescue Doses Per Hour Ratio. | Additional Rescue Doses Per Hour Ratio is the number per hour of addition of rescue dose administrated with 10% of initial NMBAs dose. The formula is {(Addition number + 1 / Anesthetic time) x 60}. | Intraoperative, an average of 3 hours. |
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