Trial record 18 of 145 for:
Cerebral Aneurysms
Valproic Acid, Magnesium Sulphate, Rocuronium Requirement, Postoperative Analgesia
This study is currently recruiting participants.
Verified December 2011 by Seoul National University Bundang Hospital
Sponsor:
Seoul National University Bundang Hospital
Information provided by (Responsible Party):
Kim Mihyun, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01460563
First received: October 19, 2011
Last updated: December 26, 2011
Last verified: December 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cerebral Aneurysm |
Drug: Magnesium Sulfate Drug: 0.9% saline |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) |
| Official Title: | Effects of Valproic Acid and Magnesium Sulphate on Rocuronium Requirement and Postoperative Analgesia in Patients Undergoing Craniotomy for Cerebrovascular Surgery |
Resource links provided by NLM:
Drug Information available for:
Valproic acid
Valproate sodium
Magnesium
Magnesium sulfate
Sulfate ion
Divalproex sodium
Rocuronium bromide
Rocuronium
U.S. FDA Resources
Further study details as provided by Seoul National University Bundang Hospital:
Primary Outcome Measures:
- Rocuronium [ Time Frame: participants will be followed for the duration of the surgery, an expected average of 5.5 hours. ] [ Designated as safety issue: No ]
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:
- 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 ] [ Designated as safety issue: Yes ]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.. ] [ Designated as safety issue: No ]total amount of propofol and remifentanil infused is measured.
- Magnesium concentration [ Time Frame: from the induction of anesthesia until end of the surgery ] [ Designated as safety issue: Yes ]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. ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]
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.
| Estimated Enrollment: | 60 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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 Name: NaCl
Drug: 0.9% saline
0.9% saline as same dose as MgSO4 as placebo
Other Name: 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 Name: NaCl
|
Detailed Description:
Magnesium sulfate (MgSO4) is known to reduce requirement of muscle relaxant.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01460563
Contacts
| Contact: Mihyun Kim, Doctor | 82-31-787-7499 | snmd56@yahoo.com |
Locations
| Korea, Republic of | |
| Seoul National University Bundang hopital | Recruiting |
| Seongnam, Gyeonggi-Do, Korea, Republic of, 463-787 | |
| Contact: Mihyun Kim, Doctor 82-31-787-7499 snmd56@yahoo.com | |
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
| Study Chair: | Sanghwan Do, Doctor | Seoul National University Bundang Hospital |
More Information
No publications provided
| Responsible Party: | Kim Mihyun, clinical professor, Seoul National University Bundang Hospital |
| ClinicalTrials.gov Identifier: | NCT01460563 History of Changes |
| Other Study ID Numbers: | Mg_orfil |
| Study First Received: | October 19, 2011 |
| Last Updated: | December 26, 2011 |
| Health Authority: | South Korea: Institutional Review Board |
Keywords provided by Seoul National University Bundang Hospital:
|
craniotomy sodium valproate rocuronium |
Additional relevant MeSH terms:
|
Aneurysm Intracranial Aneurysm Brain Diseases Vascular Diseases Cardiovascular Diseases Intracranial Arterial Diseases Cerebrovascular Disorders Central Nervous System Diseases Nervous System Diseases Valproic Acid Magnesium Sulfate Rocuronium Anticonvulsants Central Nervous System Agents Therapeutic Uses |
Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action GABA Agents Neurotransmitter Agents Physiological Effects of Drugs Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Anesthetics Anti-Arrhythmia Agents |
ClinicalTrials.gov processed this record on May 16, 2013