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Completed

NCT Number: NCT01153256

Intubating Condition After Magnesium Pre-treatment

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.

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnesium sulphate

Drug

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.

normal saline

Drug

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).

Primary outcomes

  1. the intubating conditions

    Time frame: 1 minute during intervention

    The anesthesiologist also assessed the intubating conditions as per the intubation scoring system of the Good Clinical Research Practice guideline.

Secondary outcomes

  1. mean arterial pressure (MAP)

    Time frame: 5 min before intubation, immediate before intubation, post-intubation 1, 2, 3, 4, and 5 min.

    They were recorded pre-induction (base line), just before intubation, and every minute thereafter for 5 min.

  2. heart rate (HR)

    Time frame: 5 min before intubation, immediate before intubation, post-intubation 1, 2, 3, 4, and 5 min.

    They were recorded pre-induction (base line), just before intubation, and every minute thereafter for 5 min.

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

The Influence of Magnesium Sulphate Pretreatment on Intubating Conditions During Rapid Sequence Induction

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 30, 2010
Registry last updated
Jan 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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