Cranitomy SurgeryPhase 3NCT00848991
Comparison of Propofol to Precedex With Propofol for Emergence and Recovery in Patients Having Craniotomy Surgery
A Phase 3 study testing Precedex and Propofol in people with Cranitomy Surgery, run by Cooper Norcross Health at 1 site in United States.
Trial summary
Primary Hypothesis: The use of a Precedex infusion, in addition to propofol during surgery, will improve patient management through the anesthesia postoperative recovery period determined by improvement in patients? tolerance of the endotracheal tube. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cranitomy Surgery
- What is being tested?
- Precedex and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Feb 2010
- Phase
- Phase 3
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ASA status 1, 2, and 3
Who cannot join
- ASA status 4 and 5 patients
- Patients with positive pregnancy tests
Trial locations and contacts
1 site in 1 country.
United States1 site
Cooper University Hospital
Camden, New Jersey, 08103
About this study
Official title: Comparison of Propofol Standard Anesthetic to Precedex With Propofol for Emergence and Recovery in Patients Having Craniotomy Surgery
Primary Hypothesis: The use of a Precedex infusion, in addition to propofol during surgery, will improve patient management through the anesthesia postoperative recovery period determined by improvement in patients? tolerance of the endotracheal tube.
Secondary hypothesis: The use of a Precedex infusion, in addition to propofol during surgery will provide improved hemodynamic stability.
Read the detailed description
The purpose of this study is to compare the addition of Precedex to a propofol intravenous anesthetic for emergence from anesthesia in patients having craniotomy surgery for brain tumors.
- Conditions
- Cranitomy Surgery
- Being tested
- Precedex, Propofol
- Keywords
- precedex, propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrecedexDrug
Subjects randomized to the comparison group will receive a standardized general anesthetic. Anesthesia will be induced with propofol 1.5 ? 2.5 mg/kg, rocuronium 0.6 mg/kg, and sufentanil 0.1 ? 1mcg/kg. Anesthesia will be maintained with an infusion with propofol 25 -200 mcg/kg/min, sufentanil 0.0025 - 0.03 mcg/kg/min, and zemuron as needed. For the Precedex group the drug will be infused at 0.3-0.7 mcg/kg/hr. Blood pressure will be maintained within 10% of baseline prior to opening of the dura, subsequently to be maintained between a systolic of 100 ? 130 mmHg. Hypertension will be managed with standardized amounts of labetalol and nicardipine. Morphine will be titrated as needed to a maximum of 0.05mcg/kg at the conclusion of case. Hemodynamic data and emergence evaluations will be collected in the operating room, pre-induction until the end of anesthesia and discharge from the operating room. There will be no further follow up.
PropofolDrug
evaulation of propofol for emergence from anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Precedex | Active comparator | In the operating room routine anesthesia monitors will be placed and vital signs will be recorded continuously using data collection software. A routine propofol anesthetic will be administered to subjects randomized to the control group or a Precedex infusion with propofol for subjects randomized to the treatment group. Precedex infusion will be started after induction of general anesthesia. Vital signs (SBP, DBP, MAP) will be recorded continuously throughout the surgery. At the end of the case subjects will be extubated and the blinded observer will assess emergence from anesthesia based on hemodynamic stability and tolerance of the endotracheal tube. Videotaping of emergence will be used to assist in the evaluation of emergence of anesthesia and extubation. Receives: Drug: Precedex |
| Propofol | Active comparator | Propofol for emergence from anesthesia Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The use of Precedex for craniotomy surgery offers the potential for improved hemodynamic control and improved tolerance of the endotracheal tube, therefore potentially benefiting these patients.
Measured: 4 hours after awaking from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cranitomy SurgeryStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cooper Norcross Health
- Sponsor type
- University, hospital or other
- Investigators
- Michael Misbin, MD, Principal investigator, Cooper Norcross Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00848991
- Sponsor's protocol ID
- 01
- Status last verified
- Feb 2009
- First submitted
- 17 Dec 2008
- Last updated
- 10 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Propofol Standard Anesthetic to Precedex With Propofol for Emergence and Recovery in Patients Having Craniotomy Surgery
- ClinicalTrials.gov ID
- NCT00848991
- Acronym / sponsor ID
- 01
- Conditions
- Cranitomy Surgery
- Keywords
- precedex, propofol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Cooper Norcross HealthUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 23 Feb 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.
Primary Hypothesis: The use of a Precedex infusion, in addition to propofol during surgery, will improve patient management through the anesthesia postoperative recovery period determined by improvement in patients? tolerance of the endotracheal tube.
Secondary hypothesis: The use of a Precedex infusion, in addition to propofol during surgery will provide improved hemodynamic stability.
Detailed description
The purpose of this study is to compare the addition of Precedex to a propofol intravenous anesthetic for emergence from anesthesia in patients having craniotomy surgery for brain tumors.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Precedex | Active comparator | Drug: PrecedexIn the operating room routine anesthesia monitors will be placed and vital signs will be recorded continuously using data collection software. A routine propofol anesthetic will be administered to subjects randomized to the control group or a Precedex infusion with propofol for subjects randomized to the treatment group. Precedex infusion will be started after induction of general anesthesia. Vital signs (SBP, DBP, MAP) will be recorded continuously throughout the surgery. At the end of the case subjects will be extubated and the blinded observer will assess emergence from anesthesia based on hemodynamic stability and tolerance of the endotracheal tube. Videotaping of emergence will be used to assist in the evaluation of emergence of anesthesia and extubation. |
| Propofol | Active comparator | Drug: PropofolPropofol for emergence from anesthesia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- ASA status 1, 2, and 3
Key exclusion criteria (2 listed)
- ASA status 4 and 5 patients
- Patients with positive pregnancy tests
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 |
|---|---|---|
| PrecedexSubjects randomized to the comparison group will receive a standardized general anesthetic. Anesthesia will be induced with propofol 1.5 ? 2.5 mg/kg, rocuronium 0.6 mg/kg, and sufentanil 0.1 ? 1mcg/kg. Anesthesia will be maintained with an infusion with propofol 25 -200 mcg/kg/min, sufentanil 0.0025 - 0.03 mcg/kg/min, and zemuron as needed. For the Precedex group the drug will be infused at 0.3-0.7 mcg/kg/hr. Blood pressure will be maintained within 10% of baseline prior to opening of the dura, subsequently to be maintained between a systolic of 100 ? 130 mmHg. Hypertension will be managed with standardized amounts of labetalol and nicardipine. Morphine will be titrated as needed to a maximum of 0.05mcg/kg at the conclusion of case. Hemodynamic data and emergence evaluations will be collected in the operating room, pre-induction until the end of anesthesia and discharge from the operating room. There will be no further follow up. | Drug | Precedex |
| Propofolevaulation of propofol for emergence from anesthesia | Drug | Propofol |
Primary outcome
The use of Precedex for craniotomy surgery offers the potential for improved hemodynamic control and improved tolerance of the endotracheal tube, therefore potentially benefiting these patients.
Time frame: 4 hours after awaking from surgery
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 10 Feb 2012.
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.
Michael Misbin, MD principal investigator
Cooper Norcross Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Precedex and Propofol in people with Cranitomy Surgery, run by Cooper Norcross Health at 1 site in United States.
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 1 inclusion and 2 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 10 Feb 2012. 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 United States. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The use of Precedex for craniotomy surgery offers the potential for improved hemodynamic control and improved tolerance of the endotracheal tube, therefore potentially benefiting these patients. (time frame: 4 hours after awaking from surgery). 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 10 Feb 2012.