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
  Purpose

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.


Condition Intervention
Easy of Laryngoscopy Manipulation
Vocal Cord Position or Movement
Patient Reaction to Intubation and Cuff Inflation
Mean Arterial Pressure
Heart Rate
Drug: magnesium sulphate
Drug: normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: The Influence of Magnesium Sulphate Pretreatment on Intubating Conditions During Rapid Sequence Induction

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 168
Study Start Date: December 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: group M 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.
Placebo Comparator: Group R-0.6 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).
Placebo Comparator: Group R-0.9 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).

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01153256

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Hyo-Seok Na, professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01153256     History of Changes
Other Study ID Numbers: Mg_rocu
Study First Received: April 9, 2010
Last Updated: January 6, 2012
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Cardiovascular Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on September 16, 2014