Intubating Condition After Magnesium Pre-treatment

• Sponsor: Seoul National University Bundang Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01153256
• Collaborator: (none)
• Enrollment: 168
• Location: 1
• Arms: 3
• Duration (Months): 3
• Patients Per Site Per Month: 56.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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; Drug: normal saline	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 168 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Official Title: The Influence of Magnesium Sulphate Pretreatment on Intubating Conditions During Rapid Sequence Induction
• Study Start Date: Dec 1, 2010
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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).

Outcome Measures

Primary Outcome Measures

1. the intubating conditions [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 Outcome Measures

1. mean arterial pressure (MAP) [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) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do	Korea, Republic of	463-707

Sponsors and Collaborators

• Seoul National University Bundang Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hyo-Seok Na, professor, Seoul National University Bundang Hospital
• ClinicalTrials.gov Identifier: NCT01153256
• Other Study ID Numbers: Mg_rocu
• First Posted: Jun 30, 2010
• Last Update Posted: Jan 9, 2012
• Last Verified: Jan 1, 2012

• Additional relevant MeSH terms: Magnesium Sulfate

Study Results

No Results Posted as of Jan 9, 2012