Valproic Acid, Magnesium Sulphate, Rocuronium Requirement, Postoperative Analgesia

Cerebral Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01460563
• Other study ID #: Mg_orfil
• Status: Recruiting
• Phase: N/A
• First received: October 19, 2011
• Last updated: December 26, 2011
• Start date: October 2011
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: Seoul National University Bundang Hospital
• Contact: Mihyun Kim, Doctor
• Phone: 82-31-787-7499
• Email: snmd56[@]yahoo.com
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Cerebral Aneurysm
• Intracranial Aneurysm

Intervention

Drug:
• Magnesium Sulfate
MgSO4 infusion: 50mg/kg bolus followed by continuous infusion
• 0.9% saline
0.9% saline as same dose as MgSO4 as placebo
• 0.9% saline
0.9% saline as same dose as MgSO4 as placebo

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang hopital	Seongnam	Gyeonggi-Do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	hemodynamics	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	Yes
Secondary	total amount of anesthetics	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..	No
Secondary	Magnesium concentration	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	Yes
Secondary	side effects	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.	Yes
Secondary	pain, nausea & vomiting, analgesics use, antiemetics use, nicardipine use	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	No