- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05097508
Effect of Atracurium and Rocuronium on the State and Response Entropy During Isoflurane Anesthesia
Study Overview
Status
Intervention / Treatment
Detailed Description
The study will include 40 patients fulfilling the inclusion criteria. They will be randomized into 2 equal groups by a computer generated random numbers table, each consisting of 20 patients, namely group A and group R.
- Group A: Patients will receive Atracurium.
- Group R: Patients will receive rocuronium. No premedication will be given. After the patients enter the operating room, a venous cannula will be inserted into a large peripheral vein. Data from routine monitoring, including non-invasive arterial blood pressure, oxygen saturation, and end-tidal oxygen concentration (ETO2) and end-tidal carbon dioxide concentration (ETCO2) will be collected. Neuromuscular blockade will be continuously assessed by acceleromyography using the Train-of-Four-watch SX system (made in Ireland), starting when the patients will be unconscious. RE and SE will be monitored using a Datex Ohmeda Entropy Module (M-Entropy) and the Entropy Sensor system (made in finland).
Baseline RE and SE will be recorded. Anesthesia will be induced by propofol (dose 2-3 mg/kg) and fentanyl as analgesia (dose 1-2 mg/kg). Tracheal intubation will be facilitated with rocuronium (dose 0.6 mg/kg) /atracurium (dose 0.5 mg/kg) after an acceleromyography count of 0. Anesthesia will be maintained with isoflurane in an air-O2 mixture (FiO2 0.6, 2 L/min). Mechanical ventilation will be maintained at a tidal volume of 5-7 ml/kg. Ventilator frequency will be adjusted for maintenance of an ETCO2 of 35-40 mmHg. After equilibrium for 30 minutes SE, RE and the difference between them will be recorded at MAC 0.8 and MAC 1 at two levels of muscle relaxation assessed by TOF value of 50% and 100%. Rocuronium (dose 0.01-0.012 mg/kg/min ) /atracurium (dose 0.005-0.01 mg/kg/min) will be administered as a continuous IV infusion adjusted until 50% and 100% depression of T1 ( first twitch by acceleromyography) will be observed. The entire experiment ended before the start of surgery.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Cairo, Egypt, 222
- ain shams University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients American Society of Anesthesiologists physical status (ASA) I to II.
- Male patients (to avoid bias between gender).
- Age between 20-50 years
Exclusion Criteria:
- a. Patients receiving any neuropsychiatric medications. b. Patients undergoing neurosurgical operation. c. Drug addiction. d. Body mass index (BMI) more than or equal to 40.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A: Patients will receive Atracurium.
Baseline RE and SE will be recorded.
Anesthesia will be induced by propofol (dose 2-3 mg/kg) and fentanyl as analgesia (dose 1-2 mg/kg).
Tracheal intubation will be facilitated with atracurium (dose 0.5 mg/kg) after an acceleromyography count of 0. Anesthesia will be maintained with isoflurane in an air-O2 mixture (FiO2 0.6, 2 L/min).
Mechanical ventilation will be maintained at a tidal volume of 5-7 ml/kg.
Ventilator frequency will be adjusted for maintenance of an ETCO2 of 35-40 mmHg.
After equilibrium for 30 minutes SE, RE and the difference between them will be recorded at MAC 0.8 and MAC 1 at two levels of muscle relaxation assessed by TOF value of 50% and 100%.
Atracurium (dose 0.005-0.01
mg/kg/min) will be administered as a continuous IV infusion adjusted until 50% and 100% depression of T1 ( first twitch by acceleromyography) will be observed.
The entire experiment ended before the start of surgery.
|
Anesthesia will be induced by atracurium (dose 0.5 mg/kg).After equilibrium for 30 minutes SE, RE and the difference between them will be recorded at MAC 0.8 and MAC 1 at two levels of muscle relaxation assessed by TOF value of 50% and 100%.
Atracurium (dose 0.005-0.01
mg/kg/min) will be administered as a continuous IV infusion adjusted until 50% and 100% depression of T1 ( first twitch by acceleromyography) will be observed.
The entire experiment ended before the start of surgery.
In case of hypotension (drop of blood pressure ˃20% of baseline reading), 10-30 mg of ephedrine diluted over 10 ml normal saline 0.9% will be given intravenously by titration according to the blood pressure.
In case of bradycardia (heart rate less than 60 beat per minute), when it is associated with hypotension or any signs of impaired perfusion, 0.01 - 0.02 mg/kg of atropine will be given
Other Names:
No premedication will be given.
After the patients enter the operating room, a venous cannula will be inserted into a large peripheral vein.
Data from routine monitoring, including non-invasive arterial blood pressure, oxygen saturation, and end-tidal oxygen concentration (ETO2) and end-tidal carbon dioxide concentration (ETCO2) will be collected.
Neuromuscular blockade will be continuously assessed by acceleromyography using the Train-of-Four-watch SX system , starting when the patients will be unconscious.
RE and SE will be monitored using a Datex Ohmeda Entropy Module (M-Entropy) and the Entropy Sensor system.
After the patients enter the operating room, a venous cannula will be inserted into a large peripheral vein.
Data from routine monitoring, including non-invasive arterial blood pressure, oxygen saturation, and end-tidal oxygen concentration (ETO2) and end-tidal carbon dioxide concentration (ETCO2) will be collected.
Neuromuscular blockade will be continuously assessed by acceleromyography using the Train-of-Four-watch SX system, starting when the patients will be unconscious.
RE and SE will be monitored using a Datex Ohmeda Entropy Module (M-Entropy) and the Entropy Sensor system.
|
Experimental: Group R: Patients will receive rocuronium.
Baseline RE and SE will be recorded.
Anesthesia will be induced by propofol (dose 2-3 mg/kg) and fentanyl as analgesia (dose 1-2 mg/kg).
Tracheal intubation will be facilitated with rocuronium (dose 0.6 mg/kg) after an acceleromyography count of 0. Anesthesia will be maintained with isoflurane in an air-O2 mixture (FiO2 0.6, 2 L/min).
Mechanical ventilation will be maintained at a tidal volume of 5-7 ml/kg.
Ventilator frequency will be adjusted for maintenance of an ETCO2 of 35-40 mmHg.
After equilibrium for 30 minutes SE, RE and the difference between them will be recorded at MAC 0.8 and MAC 1 at two levels of muscle relaxation assessed by TOF value of 50% and 100%.
Rocuronium (dose 0.01-0.012
mg/kg/min ) will be administered as a continuous IV infusion adjusted until 50% and 100% depression of T1 ( first twitch by acceleromyography) will be observed.
The entire experiment ended before the start of surgery.
|
No premedication will be given.
After the patients enter the operating room, a venous cannula will be inserted into a large peripheral vein.
Data from routine monitoring, including non-invasive arterial blood pressure, oxygen saturation, and end-tidal oxygen concentration (ETO2) and end-tidal carbon dioxide concentration (ETCO2) will be collected.
Neuromuscular blockade will be continuously assessed by acceleromyography using the Train-of-Four-watch SX system , starting when the patients will be unconscious.
RE and SE will be monitored using a Datex Ohmeda Entropy Module (M-Entropy) and the Entropy Sensor system.
After the patients enter the operating room, a venous cannula will be inserted into a large peripheral vein.
Data from routine monitoring, including non-invasive arterial blood pressure, oxygen saturation, and end-tidal oxygen concentration (ETO2) and end-tidal carbon dioxide concentration (ETCO2) will be collected.
Neuromuscular blockade will be continuously assessed by acceleromyography using the Train-of-Four-watch SX system, starting when the patients will be unconscious.
RE and SE will be monitored using a Datex Ohmeda Entropy Module (M-Entropy) and the Entropy Sensor system.
Anesthesia will be induced by rocuronium (dose 0.6 mg/kg).After equilibrium for 30 minutes SE, RE and the difference between them will be recorded at MAC 0.8 and MAC 1 at two levels of muscle relaxation assessed by TOF value of 50% and 100%.
Rocuronium (dose 0.01-0.012
mg/kg/min ) will be administered as a continuous IV infusion adjusted until 50% and 100% depression of T1 ( first twitch by acceleromyography) will be observed.
The entire experiment ended before the start of surgery.
In case of hypotension (drop of blood pressure ˃20% of baseline reading), 10-30 mg of ephedrine diluted over 10 ml normal saline 0.9% will be given intravenously by titration according to the blood pressure.
In case of bradycardia (heart rate less than 60 beat per minute), when it is associated with hypotension or any signs of impaired perfusion, 0.01 - 0.02 mg/kg of atropine will be given.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
to evaluate the impact of different degrees of neuromuscular blockade on SE, RE, and RE-SE difference during isoflurane anesthesia.
Time Frame: 1 year
|
to measure effect of atracurium and rocuronium on entropy readings(state,respose and difference between them) during isoflurane anesthesia
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Noran Hassanien, Ainshams university
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Neuromuscular Manifestations
- Muscle Hypotonia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Antagonists
- Cholinergic Agents
- Anticonvulsants
- Neuromuscular Agents
- Nicotinic Antagonists
- Neuromuscular Nondepolarizing Agents
- Neuromuscular Blocking Agents
- Bromides
- Rocuronium
- Atracurium
Other Study ID Numbers
- Noran Hassanien
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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