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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

April 9, 2010
January 6, 2012
December 2010
March 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01153256 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Not Provided
Not Provided
 
Intubating Condition After Magnesium Pre-treatment
The Influence of Magnesium Sulphate Pretreatment on Intubating Conditions During Rapid Sequence Induction

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
  • Easy of Laryngoscopy Manipulation
  • Vocal Cord Position or Movement
  • Patient Reaction to Intubation and Cuff Inflation
  • Mean Arterial Pressure
  • Heart Rate
  • 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).
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
168
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01153256
Mg_rocu
Not Provided
Hyo-Seok Na, Seoul National University Bundang Hospital
Seoul National University Bundang Hospital
Not Provided
Not Provided
Seoul National University Bundang Hospital
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP