Status:
COMPLETED
The Study of Pharmacokinetics and Pharmacodynamics of Cisatracurium
Lead Sponsor:
Mahidol University
Conditions:
Critical Illness
Respiratory Distress Syndrome, Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Pathophysiological changes influenced by multiple factors in critically ill patients, has a significant impact on pharmacokinetics (PK) and pharmacodynamics (PD) of cisatracurium. In order to understa...
Detailed Description
Neuromuscular blocking agents (NMBAs) are commonly used in critically ill patients, especially in adult respiratory distress syndrome (ARDS). Use of NMBAs to facilitate mechanical ventilation, to cont...
Eligibility Criteria
Inclusion
- Age greater than 18 years
- Admission for ICU care
- Require paralysis with cisatracurium as part of their clinical care
- Patients or legal representatives who are able to understand and are willing and able to give their signed informed consent before any trial-related procedures are performed
Exclusion
- Lactating women
- Pregnancy women
- Documented history of hypersensitivity to cisatracurium
- Pre-existing neuromuscular disease
- Patients with burn lesions
- Currently diagnosed of hypothermia condition (tympanic body temperature ≤ 36 °C)
- Patients currently receiving intravenous bolus or push of cisatracurium within 24 hours or receiving intravenous continuous infusion of cisatracurium within 48 hours prior to enrollment
- Patients who have to receive intravenous continuous infusion of cisatracurium within 30 minutes after given intravenous bolus of 0.2 mg/ kg cisatracurium
Key Trial Info
Start Date :
December 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03337373
Start Date
December 15 2017
End Date
August 31 2018
Last Update
March 6 2019
Active Locations (1)
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1
Faculty of Medicine Ramathibodi Hospital
Bangkok, Thailand, 10400