Intubating Condition After Magnesium Pre-treatment

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Hyo-Seok Na, Seoul National University Bundang Hospital

ClinicalTrials.gov Identifier:

NCT01153256

First received: April 9, 2010

Last updated: January 6, 2012

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	April 9, 2010
Last Updated Date	January 6, 2012
Start Date ^ICMJE	December 2010
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 29, 2010)	the intubating conditions [ Time Frame: 1 minute during intervention ] [ Designated as safety issue: No ] The anesthesiologist also assessed the intubating conditions as per the intubation scoring system of the Good Clinical Research Practice guideline.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01153256 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 17, 2011)	mean arterial pressure (MAP) [ Time Frame: 5 min before intubation, immediate before intubation, post-intubation 1, 2, 3, 4, and 5 min. ] [ Designated as safety issue: No ] They were recorded pre-induction (base line), just before intubation, and every minute thereafter for 5 min. heart rate (HR) [ Time Frame: 5 min before intubation, immediate before intubation, post-intubation 1, 2, 3, 4, and 5 min. ] [ Designated as safety issue: No ] They were recorded pre-induction (base line), just before intubation, and every minute thereafter for 5 min.
Original Secondary Outcome Measures ^ICMJE (submitted: June 29, 2010)	mean arterial pressure (MAP) [ Time Frame: 7 times, MAP is measured during the induction period of general anesthesia and thereafter 5 minutes after tracheal intubation. (descripted as below) ] [ Designated as safety issue: No ] They were recorded pre-induction (base line), just before intubation, and every minute thereafter for 5 min. heart rate (HR) [ Time Frame: 7 times, HR is measured during the induction period of general anesthsia and thereafter 5 minutes after tracheal intubation. (descripted as below) ] [ Designated as safety issue: No ] They were recorded pre-induction (base line), just before intubation, and every minute thereafter for 5 min.
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Intubating Condition After Magnesium Pre-treatment
Official Title ^ICMJE	The Influence of Magnesium Sulphate Pretreatment on Intubating Conditions During Rapid Sequence Induction
Brief Summary	Magnesium had an inhibitory effect on neuromuscular transmission and caused a decrease in muscle fiber membrane excitability. It reduces the amount of acetylcholine that is released at the motor nerve terminal by decreasing the calcium conductance of presynaptic voltage-dependent calcium channels. After pre-treatment with magnesium, an increased speed of onset and a prolongation of the recovery period of neuromuscular blockade have been observed with other non-depolarizing neuromuscular blocking agent (NMBA) such as atracurium, vecuronium and rocuronium. Rocuronium is the currently preferred NMBA used as an alternative to succinylcholine for rapid tracheal intubation. As an alternative to succinylcholine, high doses of NMBA have been tested for rapid sequence intubation. This excessively high dose of rocuronium, however, prolongs the duration of the neuromuscular block and this may not be warranted in every surgical setting. The reduction of onset time of rocuronium by magnesium pre-treatment can make intubation condition more rapid and much better clinically. It will thus be interesting to compare intubation conditions of a standard intubation dose of rocuronium after magnesium pre-treatment with high dose of rocuronium or standard dose of rocuronium.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator)
Condition ^ICMJE	Easy of Laryngoscopy Manipulation Vocal Cord Position or Movement Patient Reaction to Intubation and Cuff Inflation Mean Arterial Pressure Heart Rate
Intervention ^ICMJE	Drug: magnesium sulphate The patients of group M receive 50 mg/kg of magnesium sulphate in 100 ml of isotonic saline over 10 min immediately before anaesthesia induction. After induction of anesthesia with alfentanil (10 μg/kg) and propofol (2 mg/kg), rocuronium 0.6 mg/kg is given over 5 s in a running infusion. Drug: normal saline Patients in the group R-0.6 receive the same volume of isotonic saline over the same period, and rocuronium 0.6 mg/kg is given after the induction of anesthesia with alfentanil (10 μg/kg) and propofol (2 mg/kg). Drug: normal saline Patients in the group R-0.6 receive the same volume of isotonic saline over the same period, and rocuronium 0.9 mg/kg is given after the induction of anesthesia with alfentanil (10 μg/kg) and propofol (2 mg/kg).
Study Arm (s)	Experimental: group M Intervention: Drug: magnesium sulphate Placebo Comparator: Group R-0.6 Intervention: Drug: normal saline Placebo Comparator: Group R-0.9 Intervention: Drug: normal saline
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	168
Completion Date	March 2011
Primary Completion Date	March 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: patients undergoing operation under general anesthesia American Society of Anesthesiologist physical status I or II 20-65 year old male or female Exclusion Criteria: hepatic or renal dysfunction respiratory or cardiovascular dysfunction neurologic disorder neuromuscular disease pregnancy body mass index (BMI) >30 kg/m2 or <16.5 kg/m2 anticipated difficult airway higher magnesium level than normal range in preoperative evaluation chronic medication with calcium channel blocker or magnesium history of known allergy to magnesium sulphate or any other study drugs
Gender	Both
Ages	20 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01153256
Other Study ID Numbers ^ICMJE	Mg_rocu
Has Data Monitoring Committee	Not Provided
Responsible Party	Hyo-Seok Na, Seoul National University Bundang Hospital
Study Sponsor ^ICMJE	Seoul National University Bundang Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Seoul National University Bundang Hospital
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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