NCT01460563

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 27, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 29, 2011

Status Verified

December 1, 2011

Enrollment Period

2 months

First QC Date

October 19, 2011

Last Update Submit

December 26, 2011

Conditions

Cerebral Aneurysm

Keywords

craniotomysodium valproaterocuronium

Outcome Measures

Primary Outcomes (1)

  • Rocuronium

    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.

    participants will be followed for the duration of the surgery, an expected average of 5.5 hours.

Secondary Outcomes (5)

  • hemodynamics

    participants will be followed for the duration of the surgery, an expected average of 5.5 hours; postoperative 24 hour; postoperative 48 hour

  • total amount of anesthetics

    participants will be followed at the end of the surgery, an expected average of 5.5 hours after induction of anesthesia..

  • Magnesium concentration

    from the induction of anesthesia until end of the surgery

  • side effects

    participants will be followed for the duration of the surgery, an expected average of 5.5 hours; postoperative 24 hour; postoperative 48 hour.

  • pain, nausea & vomiting, analgesics use, antiemetics use, nicardipine use

    patients will be followed from the end of the operation until postoperativ 48 h

Study Arms (3)

Mg_orfil

EXPERIMENTAL

patients preloaded with sodium valproate receives MgSO4 during the craniotomy.

Drug: Magnesium Sulfate

control_orfil

PLACEBO COMPARATOR

patients preloaded with sodium valproate receives 0.9% saline as placebo.

Drug: 0.9% saline

control_no orfil

PLACEBO COMPARATOR

patients not preloaded with sodium valproate receives 0.9% saline as placebo.

Drug: 0.9% saline

Interventions

Magnesium SulfateDRUG

MgSO4 infusion: 50mg/kg bolus followed by continuous infusion

Also known as: MgSO4
Mg_orfil
0.9% salineDRUG

0.9% saline as same dose as MgSO4 as placebo

Also known as: NaCl
control_orfil

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang hopital

Seongnam-si, Gyeonggi-do, 463-787, South Korea

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm

Interventions

Magnesium SulfateSaline Solution

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Sanghwan Do, Doctor

    Seoul National University Bundang Hospital

    STUDY CHAIR

Central Study Contacts

Mihyun Kim, Doctor

CONTACT

82-31-787-7499snmd56@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical professor

Study Record Dates

First Submitted

October 19, 2011

First Posted

October 27, 2011

Study Start

October 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

December 29, 2011

Record last verified: 2011-12

Locations

KR(1)