- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02709473
The Effect of Propofol and Remifentanil Sequence on ED50 and ED95 of Rocuronium in Rapid Sequence Induction Anesthesia
Does the Choice of Administration Sequence of Propofol and Remifentanil Affect the ED50 and ED95 of Rocuronium for Rapid Sequence Induction of Anesthesia?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Rapid sequence induction is a widely used anesthesia technique to achieve a safe airway control. However, the difficult airway may be expected in these patients as in the others. In the difficult airway situation, cholinesterase inhibitors and sugammadex may be used for the reversal. However, sugammadex is not always available due to its cost in every hospital. In addition to this, it is well-known that cholinesterase inhibitors do not work well in case of deep neuromuscular block. In consideration of these informations, the recovery of the neuromuscular block gain an importance in patients undergoing RSI with difficult airway. Therefore, decreasing the dosage of non-depolarizing neuromuscular agent may be helpful in case of the difficult airway situations. With the aim of decreasing the neuromuscular blocker dosage, opioid analgesics especially remifentanil is preferred combined with propofol to decrease the hemodynamic response to laryngoscopy and intubation. A recent study demonstrated that after induction of anesthesia with remifentanil and propofol, ED50 of rocuronium for acceptable intubation conditions was 0.20 mg/kg. In another study, the authors showed that the administration sequence of propofol and remifentanil for target controlled anesthesia affect the onset time of rocuronium due to change in cardiac output. The authors concluded that the prior administration of remifentanil decreased the cardiac output and delayed the onset time of rocuronium.
The investigators hypothesized that prior administration of remifentanil compared to propofol may increase the ED50 and ED95 of rocuronium for acceptable intubation conditions in RSI.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Ankara, Turkey
- Ankara University
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Sanliurfa, Turkey
- Harran University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status I-II patients
- patients scheduled for elective surgery
Exclusion Criteria:
- suspected or known difficult airway
- a significant renal or hepatic dysfunction
- a known neuromuscular disease
- hypertension
- a known allergy to one of the drugs used in general anesthesia
- a body mass index lower than 18.5 kg/m2 or higher than 30 kg/m2
- intake of any medication that might interact with rocuronium
- patient refusal
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SCREENING
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: propofol
Propofol arm includes patients that induction of general anesthesia started with propofol and followed by remifentanil and rocuronium administration
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Propofol will be used in either two arms.
The injection sequence will be changed.
In propofol arm of the study, general anesthesia will be started with 2 mg/kg propofol administered within 15 seconds.
And, then remifentanil will be given.
In remifentanil arm of the study, 2 mg/kg propofol will be applied within 15 seconds following remifentanil injection.
Remifentanil will be used in either two arms.
The injection sequence will be changed.
In remifentanil arm, general anesthesia will be started with 2 μg/kg remifentanil administered within 30 seconds.
And then propofol will be given.
In propofol arm of the study the same dose will be applied within 30 seconds following propofol administration.
Other Names:
Rocuronium will be used for either two study arms.
Rocuronium will be given in a 0.8 mg/kg dosage in the first study subject.
And then, if the intubation condition is acceptable, the dose of the rocuronium will be decreased by 0.1 mg/kg for the next patient.
Otherwise, if the intubation condition is not acceptable, the rocuronium dosage will be increased by 0.1 mg/kg for the next patient.
This will be continue for ten crossover points (the point that turn from unsuccessful intubation to successful intubation).
Other Names:
|
ACTIVE_COMPARATOR: remifentanil
Remifentanil arm include patients that induction of general anesthesia started with remifentanil and followed by propofol and rocuronium administration
|
Propofol will be used in either two arms.
The injection sequence will be changed.
In propofol arm of the study, general anesthesia will be started with 2 mg/kg propofol administered within 15 seconds.
And, then remifentanil will be given.
In remifentanil arm of the study, 2 mg/kg propofol will be applied within 15 seconds following remifentanil injection.
Remifentanil will be used in either two arms.
The injection sequence will be changed.
In remifentanil arm, general anesthesia will be started with 2 μg/kg remifentanil administered within 30 seconds.
And then propofol will be given.
In propofol arm of the study the same dose will be applied within 30 seconds following propofol administration.
Other Names:
Rocuronium will be used for either two study arms.
Rocuronium will be given in a 0.8 mg/kg dosage in the first study subject.
And then, if the intubation condition is acceptable, the dose of the rocuronium will be decreased by 0.1 mg/kg for the next patient.
Otherwise, if the intubation condition is not acceptable, the rocuronium dosage will be increased by 0.1 mg/kg for the next patient.
This will be continue for ten crossover points (the point that turn from unsuccessful intubation to successful intubation).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ED50 of rocuronium
Time Frame: One minute after rocuronium injection
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ED50 of rocuronium means the dose of rocuronium that is required for providing acceptable intubation conditions in the 50% of patients undergoing intubation.
Each individual dose that allow or not allow an acceptable intubation condition will determine the next patient rocuronium dose.
At the end, ED50 of rocuronium will be calculated as means of drug dosage that providing acceptable intubation condition.
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One minute after rocuronium injection
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ED95 of rocuronium
Time Frame: One minute after rocuronium injection
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ED595 of rocuronium means the dose of rocuronium that is required for providing acceptable intubation conditions in the 95% of patients undergoing intubation.
Each individual dose that allow or not allow an acceptable intubation condition will determine the next patient rocuronium dose.
At the end, ED95 of rocuronium will be estimated by using statistical tools such as pava estimator or R code.
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One minute after rocuronium injection
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mean arterial blood pressure
Time Frame: before and after 10 minutes of induction of anesthesia
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the effect of propofol and remifentanil administration sequence on mean arterial blood pressure will be evaluated.
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before and after 10 minutes of induction of anesthesia
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ozlem Can, Assoc Prof, Ankara University Department of Anesthesiology and Intensive Care Medicine
Publications and helpful links
General Publications
- Oh AY, Cho SJ, Seo KS, Ryu JH, Han SH, Hwang JW. Dose of rocuronium for rapid tracheal intubation following remifentanil 2 mug kg-1 and propofol 2 mg kg-1. Eur J Anaesthesiol. 2013 Sep;30(9):550-5. doi: 10.1097/EJA.0b013e3283622ba0.
- Na HS, Hwang JW, Park SH, Oh AY, Park HP, Jeon YT, Do SH. Drug-administration sequence of target-controlled propofol and remifentanil influences the onset of rocuronium. A double-blind, randomized trial. Acta Anaesthesiol Scand. 2012 May;56(5):558-64. doi: 10.1111/j.1399-6576.2012.02648.x. Epub 2012 Feb 7.
- Dewhirst E, Tobias JD, Martin DP. Propofol and remifentanil for rapid sequence intubation in a pediatric patient at risk for aspiration with elevated intracranial pressure. Pediatr Emerg Care. 2013 Nov;29(11):1201-3. doi: 10.1097/PEC.0b013e3182aa136d.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Hypnotics and Sedatives
- Neuromuscular Agents
- Neuromuscular Nondepolarizing Agents
- Neuromuscular Blocking Agents
- Remifentanil
- Propofol
- Rocuronium
Other Study ID Numbers
- 31-31412
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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