Intubating Condition After Magnesium Pre-treatment

NCT01153256 | Completed

• 1 other identifier: Mg_rocu
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Easy of Laryngoscopy Manipulation; Vocal Cord Position or Movement; Patient Reaction to Intubation and Cuff Inflation; Mean Arterial Pressure; Heart Rate

Outcome Measures

Primary Outcomes (1)

• the intubating conditions

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

  1 minute during intervention

Secondary Outcomes (2)

• mean arterial pressure (MAP)

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

• heart rate (HR)

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

Study Arms (3)

group M

EXPERIMENTAL

Drug: magnesium sulphate

Group R-0.6

PLACEBO COMPARATOR

Drug: normal saline

Group R-0.9

PLACEBO COMPARATOR

Drug: normal saline

Interventions

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.

group M

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).

Group R-0.6

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing operation under general anesthesia
• American Society of Anesthesiologist physical status I or II
• year old male or female

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

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

Location

MeSH Terms

Interventions

Magnesium Sulfate; Saline Solution

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 9, 2010
• First Posted: June 30, 2010
• Study Start: December 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: January 9, 2012

Record last verified: 2012-01

Locations

KR (1)