Valproic Acid, Magnesium Sulphate, Rocuronium Requirement, Postoperative Analgesia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Seoul National University Bundang Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Kim Mihyun, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01460563
First received: October 19, 2011
Last updated: December 26, 2011
Last verified: December 2011
  Purpose

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 Intervention
Cerebral Aneurysm
Drug: Magnesium Sulfate
Drug: 0.9% saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • Rocuronium [ Time Frame: participants will be followed for the duration of the surgery, an expected average of 5.5 hours. ] [ Designated as safety issue: No ]

    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:
  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • 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.. ] [ Designated as safety issue: No ]
    total amount of propofol and remifentanil infused is measured.

  • Magnesium concentration [ Time Frame: from the induction of anesthesia until end of the surgery ] [ Designated as safety issue: Yes ]
    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.

  • 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. ] [ Designated as safety issue: Yes ]
    complicaton associated with MgSO4 including muscle weakness, hot flush, and nausea/ vomiting.

  • 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 ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 60
Study Start Date: October 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Magnesium sulfate (MgSO4) is known to reduce requirement of muscle relaxant.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01460563

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

Locations
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
Study Chair: Sanghwan Do, Doctor Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Kim Mihyun, clinical professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01460563     History of Changes
Other Study ID Numbers: Mg_orfil
Study First Received: October 19, 2011
Last Updated: December 26, 2011
Health Authority: South Korea: Institutional Review Board

Keywords provided by Seoul National University Bundang Hospital:
craniotomy
sodium valproate
rocuronium

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Brain Diseases
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Central Nervous System Diseases
Nervous System Diseases
Valproic Acid
Magnesium Sulfate
Rocuronium
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on July 24, 2014