Valproic Acid, Magnesium Sulphate, Rocuronium Requirement, Postoperative Analgesia

December 26, 2011 updated by: Kim Mihyun, Seoul National University Bundang Hospital

Effects of Valproic Acid and Magnesium Sulphate on Rocuronium Requirement and Postoperative Analgesia in Patients Undergoing Craniotomy for Cerebrovascular Surgery

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-Do
      • Seongnam, Gyeonggi-Do, Korea, Republic of, 463-787
        • Recruiting
        • Seoul National University Bundang Hopital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
participants will be followed for the duration of the surgery, an expected average of 5.5 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
participants will be followed at the end of the surgery, an expected average of 5.5 hours after induction of anesthesia..
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.
from the induction of anesthesia until 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.
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
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.
patients will be followed from the end of the operation until postoperativ 48 h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Study Chair: Sanghwan Do, Doctor, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

October 19, 2011

First Submitted That Met QC Criteria

October 26, 2011

First Posted (Estimate)

October 27, 2011

Study Record Updates

Last Update Posted (Estimate)

December 29, 2011

Last Update Submitted That Met QC Criteria

December 26, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mg_orfil

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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