Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00405977
Status:
COMPLETED
Last Update Posted:
2011-09-19
First Post:
2006-11-29
Brief Title:
The Effect of Magnesium Sulphate on the Time Course of Rocuronium Induced Neuromuscular Block
Sponsor:
University Hospital Geneva
Organization:
University Hospital Geneva
Study Overview
Official Title:
The Effect of Magnesium Sulphate on the Time Course of Rocuronium Induced Neuromuscular Block - A Randomised Electrophysiology Study
Status:
COMPLETED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MagRoc
Brief Summary:
The aim of this study is to investigate whether an optimized pre-treatment with intravenous magnesium enhances the speed of onset of a standard intubation dose of rocuronium
Detailed Description:
In a previous study pre-treatment with intravenous MgSO4 60 mg kg-1 was not shown to have any impact on the onset of action of rocuronium Kussmann et al 1997 Yet in that study MgSO4 was injected as a bolus after induction of anaesthesia one minute only before the injection of the neuromuscular blocking agent We suppose that magnesium needs some time to penetrate the neuromuscular endplate and to shift the MgCa ratio in favor of magnesium Thus the particular design of the previous study may explain why magnesium had no scope to enhance the speed of onset of action of rocuronium
The aim of our study is to investigate whether an optimised pre-treatment with magnesium short infusion rather than bolus injection reasonable delay between administration of magnesium and subsequent injection of the neuromuscular blocking agent enhances the speed of onset of a standard intubation dose of rocuronium
1 Preanaesthetic preparation
Solid food and liquid intake will not be allowed for a minimum of six hours before induction
Patients will be premedicated with 75 mg oral midazolam 45 min prior to induction
Standard monitoring will consist of ECG SaO2 ETCO2 non-invasive blood pressure rectal or oesophageal T
2 Study drug administration
Intravenous infusion of the study solution 1 ml per kg bodyweight corresponding to MgSO4 60 mg kg-1 in the magnesium group The infusion will be given with an Infusomat during 15 minutes
3 Induction and maintenance of anaesthesia
At the end of the study drug infusion and after a preoxygenation period of three minutes anaesthesia will be induced with sufentanil 02µg kg-1 and propofol using a Target Controlled Infusion TCI system Base Primea Fresenius-Vial Brezins France and the pharmacokinetic model of Schnider et al Schnider et al 1999 The initial effect site concentration will be 4 µg ml-1
Maintenance of anaesthesia will be with a propofol effect site
4 Neuromuscular monitoring
Neuromuscular function will be monitored using the TOF Watch SX NV Organon and TOF nerve stimulation The guidelines for good clinical research practice in pharmacodynamic studies of NMBAs will be followed
The ulnar nerve is stimulated through surface electrodes and the adductor pollicis muscle response is measured
After the stabilisation period rocuronium 06 mg kg-1 2 x ED95 will be injected intravenously during 5 seconds
The trachea will be intubated after a 95 depression of the first twitch
51 Neuromuscular measurements
Onset time time from beginning of injection of rocuronium until a 95 depression of the first twitch T1
Duration 25 time from beginning of injection of rocuronium until 25 T1 recovery
Recovery index T25-75 time between 25 T1 recovery and 75 T1 recovery
Clinical recovery T25 - 09 time between 25 T1 recovery and TOF ratio T1T4 of 09 corresponding to safe extubation condition
52 Haemodynamics
Blood pressure
Heart rate These measurements will be done before baseline and at 5-minute intervals during the study drug infusion Before and immediately after tracheal intubation haemodynamic measurements will be repeated
53 Adverse events safety
Any minor adverse event no need for intervention or major adverse events will be recorded
The aim of our study is to investigate whether an optimised pre-treatment with magnesium short infusion rather than bolus injection reasonable delay between administration of magnesium and subsequent injection of the neuromuscular blocking agent enhances the speed of onset of a standard intubation dose of rocuronium
1 Preanaesthetic preparation
Solid food and liquid intake will not be allowed for a minimum of six hours before induction
Patients will be premedicated with 75 mg oral midazolam 45 min prior to induction
Standard monitoring will consist of ECG SaO2 ETCO2 non-invasive blood pressure rectal or oesophageal T
2 Study drug administration
Intravenous infusion of the study solution 1 ml per kg bodyweight corresponding to MgSO4 60 mg kg-1 in the magnesium group The infusion will be given with an Infusomat during 15 minutes
3 Induction and maintenance of anaesthesia
At the end of the study drug infusion and after a preoxygenation period of three minutes anaesthesia will be induced with sufentanil 02µg kg-1 and propofol using a Target Controlled Infusion TCI system Base Primea Fresenius-Vial Brezins France and the pharmacokinetic model of Schnider et al Schnider et al 1999 The initial effect site concentration will be 4 µg ml-1
Maintenance of anaesthesia will be with a propofol effect site
4 Neuromuscular monitoring
Neuromuscular function will be monitored using the TOF Watch SX NV Organon and TOF nerve stimulation The guidelines for good clinical research practice in pharmacodynamic studies of NMBAs will be followed
The ulnar nerve is stimulated through surface electrodes and the adductor pollicis muscle response is measured
After the stabilisation period rocuronium 06 mg kg-1 2 x ED95 will be injected intravenously during 5 seconds
The trachea will be intubated after a 95 depression of the first twitch
51 Neuromuscular measurements
Onset time time from beginning of injection of rocuronium until a 95 depression of the first twitch T1
Duration 25 time from beginning of injection of rocuronium until 25 T1 recovery
Recovery index T25-75 time between 25 T1 recovery and 75 T1 recovery
Clinical recovery T25 - 09 time between 25 T1 recovery and TOF ratio T1T4 of 09 corresponding to safe extubation condition
52 Haemodynamics
Blood pressure
Heart rate These measurements will be done before baseline and at 5-minute intervals during the study drug infusion Before and immediately after tracheal intubation haemodynamic measurements will be repeated
53 Adverse events safety
Any minor adverse event no need for intervention or major adverse events will be recorded
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None