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Valproic Acid, Magnesium Sulphate, Rocuronium Requirement, Postoperative Analgesia

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ClinicalTrials.gov Identifier: NCT01460563
Recruitment Status : Unknown
Verified December 2011 by Kim Mihyun, Seoul National University Bundang Hospital.
Recruitment status was:  Recruiting
First Posted : October 27, 2011
Last Update Posted : December 29, 2011
Sponsor:
Information provided by (Responsible Party):
Kim Mihyun, Seoul National University Bundang Hospital

Study Description
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Brief Summary:
The investigators hypothesized that valproic acid will increase rocuronium requirement and MgSO4 infusion would reduce requirement of muscle relaxant in craniotomy patients preloaded with sodium valproate.

Condition or disease Intervention/treatment Phase
Cerebral Aneurysm Drug: Magnesium Sulfate Drug: 0.9% saline Not Applicable

Detailed Description:
Magnesium sulfate (MgSO4) is known to reduce requirement of muscle relaxant.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Effects of Valproic Acid and Magnesium Sulphate on Rocuronium Requirement and Postoperative Analgesia in Patients Undergoing Craniotomy for Cerebrovascular Surgery
Study Start Date : October 2011
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Mg_orfil
patients preloaded with sodium valproate receives MgSO4 during the craniotomy.
 Drug: Magnesium Sulfate
MgSO4 infusion: 50mg/kg bolus followed by continuous infusion
Other Name: MgSO4
Placebo Comparator: control_orfil
patients preloaded with sodium valproate receives 0.9% saline as placebo.
 Drug: 0.9% saline
0.9% saline as same dose as MgSO4 as placebo
Other Name: NaCl

Drug: 0.9% saline
0.9% saline as same dose as MgSO4 as placebo
Other Name: NaCl
Placebo Comparator: control_no orfil
patients not preloaded with sodium valproate receives 0.9% saline as placebo.
 Drug: 0.9% saline
0.9% saline as same dose as MgSO4 as placebo
Other Name: NaCl


Outcome Measures
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Primary Outcome Measures :
  1. Rocuronium [ Time Frame: participants will be followed for the duration of the surgery, an expected average of 5.5 hours. ]

    Roc 0.15mg/kg is injected when train of four (TOF) becomes 2 which is measured with TOF-watch Sx. The total amount of Roc that injected is recorded.

    The intervals of each Roc 0.15mg/kg injection will also be recorded.



Secondary Outcome Measures :
  1. hemodynamics [ Time Frame: participants will be followed for the duration of the surgery, an expected average of 5.5 hours; postoperative 24 hour; postoperative 48 hour ]
    mean arterial pressure and heart rate is measured for the duration of the surgery, an expected average of 5.5 hours; postoperative 24 hour; postoperative 48 hour.

  2. total amount of anesthetics [ Time Frame: participants will be followed at the end of the surgery, an expected average of 5.5 hours after induction of anesthesia.. ]
    total amount of propofol and remifentanil infused is measured.

  3. Magnesium concentration [ Time Frame: from the induction of anesthesia until end of the surgery ]
    serum Magnesium concentration is measured just prior to anesthetic drug administration, 3 hour after the induction of anesthesia, and at the end of the surgery.

  4. side effects [ Time Frame: participants will be followed for the duration of the surgery, an expected average of 5.5 hours; postoperative 24 hour; postoperative 48 hour. ]
    complicaton associated with MgSO4 including muscle weakness, hot flush, and nausea/ vomiting.

  5. pain, nausea & vomiting, analgesics use, antiemetics use, nicardipine use [ Time Frame: patients will be followed from the end of the operation until postoperativ 48 h ]

    Pain will be assessed using numeric rating scale at 6 h, 24 h, and 48 h postoperately.

    Cumulative dose of analgesics and nicardipine, incidence of nicardipine and antiemtics use during 48h postoperatively will be recorded.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18- 65 years
  • American society of anesthesiology physical status 1,2
  • scheduled for elective craniotomy for aneurysm clipping or for superficial temporal artery-middle cerebral artery anastomosis

Exclusion Criteria:

body mass index <18.5 or >24.9 kg m-2; neuromuscular, renal, cardiovascular or hepatic insufficiency; Glasgow coma scale (GCS) <15; allergy to the study drugs; medications influencing NDMRs; breast feeding; pregnancy; and preoperative epilepsy.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460563


Contacts
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Contact: Mihyun Kim, Doctor 82-31-787-7499 snmd56@yahoo.com

Locations
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Korea, Republic of
Seoul National University Bundang hopital Recruiting
Seongnam, Gyeonggi-Do, Korea, Republic of, 463-787
Contact: Mihyun Kim, Doctor    82-31-787-7499    snmd56@yahoo.com   
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
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Study Chair: Sanghwan Do, Doctor Seoul National University Bundang Hospital
More Information
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Responsible Party: Kim Mihyun, clinical professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01460563    
Other Study ID Numbers: Mg_orfil
First Posted: October 27, 2011    Key Record Dates
Last Update Posted: December 29, 2011
Last Verified: December 2011
Keywords provided by Kim Mihyun, Seoul National University Bundang Hospital:
craniotomy
sodium valproate
rocuronium
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Magnesium Sulfate
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Tocolytic Agents
Reproductive Control Agents