N/A
N=81
Optimal Dose of Combination of Rocuronium and Cisatracurium
Chronic Otitis Media · Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT02495038 ↗Enrolled (actual)
81
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Onset of Neuromuscular Blocking Agents(NMBAs) — 212.8; 230.1; 399.3 Second
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 10% reduction of combination of Esmeron® and Nimbex® (Drug); 20% reduction of combination of Esmeron® and Nimbex® (Drug)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- Yonsei University
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Onset of Neuromuscular Blocking Agents(NMBAs) |
212.8; 230.1; 399.3 | — |
| PRIMARY Duration 25% of Neuromuscular Blocking Agents(NMBAs) |
51.3; 47.9; 39.4 | — |
| PRIMARY Recovery Index of Neuromuscular Blocking Agents(NMBAs) |
15.9; 16.2; 14.1 | — |
| SECONDARY Operation Time |
151.8; 147.0; 145.9 | — |
| SECONDARY Anesthetic Time |
163.0; 159.9; 161.4 | — |
| SECONDARY Additional Rescue Doses Per Hour Ratio. |
1.43455; 1.21014; 0.82128 | — |
Summary
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02495038). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.