Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Valproic Acid, Magnesium Sulphate, Rocuronium Requirement, Postoperative Analgesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 19, 2011
First Posted Date  ICMJE October 27, 2011
Last Update Posted Date December 29, 2011
Study Start Date  ICMJE October 2011
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 26, 2011)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2011)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2011)
  • 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.
  • 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Valproic Acid, Magnesium Sulphate, Rocuronium Requirement, Postoperative Analgesia
Official Title  ICMJE Effects of Valproic Acid and Magnesium Sulphate on Rocuronium Requirement and Postoperative Analgesia in Patients Undergoing Craniotomy for Cerebrovascular Surgery
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.
Detailed Description Magnesium sulfate (MgSO4) is known to reduce requirement of muscle relaxant.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition  ICMJE Cerebral Aneurysm
Intervention  ICMJE
  • Drug: Magnesium Sulfate
    MgSO4 infusion: 50mg/kg bolus followed by continuous infusion
    Other Name: MgSO4
  • Drug: 0.9% saline
    0.9% saline as same dose as MgSO4 as placebo
    Other Name: NaCl
Study Arms  ICMJE
  • Experimental: Mg_orfil
    patients preloaded with sodium valproate receives MgSO4 during the craniotomy.
    Intervention: Drug: Magnesium Sulfate
  • Placebo Comparator: control_orfil
    patients preloaded with sodium valproate receives 0.9% saline as placebo.
    Interventions:
    • Drug: 0.9% saline
    • Drug: 0.9% saline
  • Placebo Comparator: control_no orfil
    patients not preloaded with sodium valproate receives 0.9% saline as placebo.
    Intervention: Drug: 0.9% saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 26, 2011)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2011
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01460563
Other Study ID Numbers  ICMJE Mg_orfil
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kim Mihyun, Seoul National University Bundang Hospital
Study Sponsor  ICMJE Seoul National University Bundang Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Sanghwan Do, Doctor Seoul National University Bundang Hospital
PRS Account Seoul National University Bundang Hospital
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP