Cerebral AneurysmNCT01460563
Valproic Acid, Magnesium Sulphate, Rocuronium Requirement, Postoperative Analgesia
A study testing Magnesium Sulfate and 0.9% saline in people with Cerebral Aneurysm, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cerebral Aneurysm
- What is being tested?
- Magnesium Sulfate and 0.9% saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2011to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang hopital
Seongnam-si, Gyeonggi-do, 463-787
Mihyun Kim, Doctor, 82-31-787-7499, snmd56@yahoo.com
About this study
Official title: 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.
Read the detailed description
Magnesium sulfate (MgSO4) is known to reduce requirement of muscle relaxant.
- Conditions
- Cerebral Aneurysm
- Being tested
- Magnesium Sulfate, 0.9% saline
- Keywords
- craniotomy, sodium valproate, rocuronium
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium SulfateDrug
Also called MgSO4
MgSO4 infusion: 50mg/kg bolus followed by continuous infusion
0.9% salineDrug
Also called NaCl
0.9% saline as same dose as MgSO4 as placebo
0.9% salineDrug
Also called NaCl
0.9% saline as same dose as MgSO4 as placebo
| Study group | Role | What they receive |
|---|---|---|
| Mg_orfil | Experimental | patients preloaded with sodium valproate receives MgSO4 during the craniotomy. Receives: Drug: Magnesium Sulfate |
| control_orfil | Placebo comparator | patients preloaded with sodium valproate receives 0.9% saline as placebo. Receives: Drug: 0.9% saline |
| control_no orfil | Placebo comparator | patients not preloaded with sodium valproate receives 0.9% saline as placebo. Receives: Drug: 0.9% saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: participants will be followed for the duration of the surgery, an expected average of 5.5 hours.
Secondary outcomes (5)
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.
Measured: 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
total amount of propofol and remifentanil infused is measured.
Measured: participants will be followed at the end of the surgery, an expected average of 5.5 hours after induction of anesthesia..
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.
Measured: from the induction of anesthesia until end of the surgery
side effects
complicaton associated with MgSO4 including muscle weakness, hot flush, and nausea/ vomiting.
Measured: 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
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.
Measured: patients will be followed from the end of the operation until postoperativ 48 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral AneurysmStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Mihyun, Seoul National University Bundang Hospital
- Investigators
- Sanghwan Do, Doctor, Study chair, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01460563
- Sponsor's protocol ID
- Mg_orfil
- Status last verified
- Dec 2011
- First submitted
- 19 Oct 2011
- Last updated
- 29 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Valproic Acid and Magnesium Sulphate on Rocuronium Requirement and Postoperative Analgesia in Patients Undergoing Craniotomy for Cerebrovascular Surgery
- ClinicalTrials.gov ID
- NCT01460563
- Acronym / sponsor ID
- Mg_orfil
- Conditions
- Cerebral Aneurysm
- Keywords
- craniotomy, sodium valproate, rocuronium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 27 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mg_orfil | Experimental | Drug: Magnesium Sulfatepatients preloaded with sodium valproate receives MgSO4 during the craniotomy. |
| control_orfil | Placebo comparator | Drug: 0.9% salinepatients preloaded with sodium valproate receives 0.9% saline as placebo. |
| control_no orfil | Placebo comparator | Drug: 0.9% salinepatients not preloaded with sodium valproate receives 0.9% saline as placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium SulfateAlso: MgSO4MgSO4 infusion: 50mg/kg bolus followed by continuous infusion | Drug | Mg_orfil |
| 0.9% salineAlso: NaCl0.9% saline as same dose as MgSO4 as placebo | Drug | control_orfil |
| 0.9% salineAlso: NaCl0.9% saline as same dose as MgSO4 as placebo | Drug | control_no orfil, control_orfil |
Primary outcome
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.
5 secondary outcomes
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
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..
Magnesium concentration
Time frame: 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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanghwan Do, Doctor study chair
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium Sulfate and 0.9% saline in people with Cerebral Aneurysm, run by Seoul National University Bundang Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mihyun Kim, Doctor (82-31-787-7499, snmd56@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rocuronium (time frame: participants will be followed for the duration of the surgery, an expected average of 5.5 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2011.