Intubating Condition After Magnesium Pre-treatment

NCT ID: NCT01153256

Last Updated: 2012-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2011-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: TRIPLE

Study Groups

group M

Group Type: EXPERIMENTAL

magnesium sulphate

Intervention Type: 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 R-0.6

Group Type: PLACEBO_COMPARATOR

normal saline

Intervention Type: 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-0.9

Group Type: PLACEBO_COMPARATOR

normal saline

Intervention Type: DRUG

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).

Interventions

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.

Intervention Type: 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).

Intervention Type: 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).

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Bundang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hyo-Seok Na

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

Mg_rocu

Identifier Type: -

Identifier Source: org_study_id