Supratentorial Craniotomy DysfunctionPhase 2NCT00975910
Effect of Lidocaine in Antiarrhythmic Dosage on Postoperative Cognitive Dysfunction in Supratentorial Craniotomy Dysfunction in Supratentorial Craniotomy
A Phase 2 study testing lidocaine and saline in people with Supratentorial Craniotomy Dysfunction, run by Capital Medical University at 1 site in China.
Trial summary
The purpose of this study is to investigate the effect of lidocaine in antiarrhythmic dosage on postoperative cognitive dysfunction in supratentorial craniotomy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Supratentorial Craniotomy Dysfunction
- What is being tested?
- lidocaine and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Sep 2009to Dec 2012
- Phase
- Phase 2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-60 years old, ASA physical status I or II, BMI<30
- Scheduled for elective supratentorial craniotomy
- MMSE<24 before operation
- Cooperative and given informed consent in person
Who cannot join
- History of mental or psychiatric disorders
- Contraindicated to internal jugular venous catheterization
- Pregnant or lactating female
- History of systemic malignant tumor or diabetes
- Previously treated with this protocol or participated in another study within previous 30 days
- Suspected history of allergic reaction or intolerance to amides or other anesthetic agents in this study
- History of alcohol abuse and/or drug abuse within previous one year
- History or a family history of malignant hyperthermia
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology,Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
About this study
The purpose of this study is to investigate the effect of lidocaine in antiarrhythmic dosage on postoperative cognitive dysfunction in supratentorial craniotomy.
- Conditions
- Supratentorial Craniotomy Dysfunction
- Being tested
- lidocaine, saline
- Keywords
- Supratentorial Craniotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaineDrug
Lidocaine arm: lidocaine (2%) as an intravenous bolus (1.5 mg/kg) during induction followed by an intravenous infusion (2 mg. kg(-1).h(-1)) after induction until at the end of surgery
salineDrug
Saline arm: infused at the same rate as lidocaine
| Study group | Role | What they receive |
|---|---|---|
| Saline | Placebo comparator | Not described Receives: Drug: saline |
| Lidocaine | Active comparator | Not described Receives: Drug: lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Examination (MMSE)
Measured: Preoperatively, 3 days and 3 months postoperatively
Montreal Cognitive Assessment (MoCA)
Measured: Preoperatively, 3 days and 3 months postoperatively
Hamilton Depression Scale (HAMD)
Measured: Preoperatively, 3 days and 3 months postoperatively
Clinical Dementia Rating (CDR)
Measured: Preoperatively, 3 days and 3 months postoperatively
Confusion Assessment Method for the Diagnosis of Delirium in the Intensive Care unit (ICU) (CAM-ICU)
Measured: 1 day and 3 days postoperatively
Secondary outcomes (6)
AjDO2 (Arterial Jugular Difference)
Measured: Injection of test dosage, 1 hour, 2 hours, 3 hours after injection of test dosage, end of surgery
AjDGlc
Measured: Injection of test dosage, 1 hour, 2 hours, 3 hours after injection of test dosage, end of surgery
AjDGlutamate
Measured: Injection of test dosage, 1 hour, 2 hours, 3 hours after injection of test dosage, end of surgery
AjDLct
Measured: Injection of test dosage, 1 hour, 2 hours, 3 hours after injection of test dosage, end of surgery
S100
Measured: Injection of test dosage, end of surgery, 24 hours after operation
Amyloid-β protein(Aβ)
Measured: Injection of test dosage, end of surgery, 24 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionMay 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supratentorial Craniotomy DysfunctionStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- State University of New York - Downstate Medical Center
- Responsible party
- Principal investigator, Wei Zhang, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975910
- Sponsor's protocol ID
- 20090801
- Status last verified
- May 2013
- First submitted
- 11 Sep 2009
- Last updated
- 22 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lidocaine in Antiarrhythmic Dosage on Postoperative Cognitive Dysfunction in Supratentorial Craniotomy Dysfunction in Supratentorial Craniotomy
- ClinicalTrials.gov ID
- NCT00975910
- Acronym / sponsor ID
- 20090801
- Conditions
- Supratentorial Craniotomy Dysfunction
- Keywords
- Supratentorial Craniotomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- State University of New York - Downstate Medical Center
- Study start
- Sep 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 14 Sep 2009 (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 purpose of this study is to investigate the effect of lidocaine in antiarrhythmic dosage on postoperative cognitive dysfunction in supratentorial craniotomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline | Placebo comparator | Drug: saline |
| Lidocaine | Active comparator | Drug: lidocaine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-60 years old, ASA physical status I or II, BMI<30
- Scheduled for elective supratentorial craniotomy
- MMSE<24 before operation
- Cooperative and given informed consent in person
Key exclusion criteria (8 listed)
- History of mental or psychiatric disorders
- Contraindicated to internal jugular venous catheterization
- Pregnant or lactating female
- History of systemic malignant tumor or diabetes
- Previously treated with this protocol or participated in another study within previous 30 days
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 |
|---|---|---|
| lidocaineLidocaine arm: lidocaine (2%) as an intravenous bolus (1.5 mg/kg) during induction followed by an intravenous infusion (2 mg. kg(-1).h(-1)) after induction until at the end of surgery | Drug | Lidocaine |
| salineSaline arm: infused at the same rate as lidocaine | Drug | Saline |
Primary outcome
Mini-Mental State Examination (MMSE)
Time frame: Preoperatively, 3 days and 3 months postoperatively
Montreal Cognitive Assessment (MoCA)
Time frame: Preoperatively, 3 days and 3 months postoperatively
Hamilton Depression Scale (HAMD)
Time frame: Preoperatively, 3 days and 3 months postoperatively
Clinical Dementia Rating (CDR)
Time frame: Preoperatively, 3 days and 3 months postoperatively
Confusion Assessment Method for the Diagnosis of Delirium in the Intensive Care unit (ICU) (CAM-ICU)
Time frame: 1 day and 3 days postoperatively
6 secondary outcomes
AjDO2 (Arterial Jugular Difference)
Time frame: Injection of test dosage, 1 hour, 2 hours, 3 hours after injection of test dosage, end of surgery
AjDGlc
Time frame: Injection of test dosage, 1 hour, 2 hours, 3 hours after injection of test dosage, end of surgery
AjDGlutamate
Time frame: Injection of test dosage, 1 hour, 2 hours, 3 hours after injection of test dosage, end of surgery
AjDLct
Time frame: Injection of test dosage, 1 hour, 2 hours, 3 hours after injection of test dosage, end of surgery
S100
Time frame: Injection of test dosage, end of surgery, 24 hours after operation
Amyloid-β protein(Aβ)
Time frame: Injection of test dosage, end of surgery, 24 hours after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2013.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lidocaine and saline in people with Supratentorial Craniotomy Dysfunction, run by Capital Medical University at 1 site in China.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 22 May 2013. 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 China. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Mental State Examination (MMSE) (time frame: Preoperatively, 3 days and 3 months postoperatively). The study lists 5 primary outcomes in all. 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 22 May 2013.