Valproic Acid, Magnesium Sulphate, Rocuronium Requirement, Postoperative Analgesia

Not Applicable

• Conditions: Cerebral Aneurysm
• Interventions: Drug: 0.9% saline; Drug: Magnesium Sulfate

• Registration Number: NCT01460563
• Lead Sponsor: Seoul National University Bundang Hospital

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 Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-19
• Study First Submitted QC: 2011-10-26
• Study First Posted: 2011-10-27
• Status Verified: 2011-12
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Last Update Submitted: 2011-12-26
• Last Update Posted: 2011-12-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control_orfil	0.9% saline	patients preloaded with sodium valproate receives 0.9% saline as placebo.
control_no orfil	0.9% saline	patients not preloaded with sodium valproate receives 0.9% saline as placebo.
Mg_orfil	Magnesium Sulfate	patients preloaded with sodium valproate receives MgSO4 during the craniotomy.

Primary Outcome Measures

Name	Time	Method
Rocuronium	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.

Secondary Outcome Measures

Name	Time	Method
hemodynamics	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	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	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	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	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.

Trial Locations

Locations (1)

Seoul National University Bundang hopital; 🇰🇷 Seongnam, Gyeonggi-Do, Korea, Republic of