AnesthesiaSPINNCT00597740
Propofol Sedation Study
An observational study of Anesthesia, run by Scottsdale Healthcare at 1 site in United States.
Trial summary
Purpose of Protocol: The purpose of this study will be to compare the clinical utility of Propofol sedation with and without the use of the ICU Sedation Protocol. Patients will be treated according to the attending/consulting preference. No attempt will be made to influence the patient's routine care and management. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anesthesia
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Dec 2013
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Neurotrauma ICU patients brought to our level one trauma facility requiring intubation.
Who may be able to join
- Ages 18-80 (inclusive)
- Admitted to trauma service
- Intubated and on respiratory support
- Neurosurgical consultation for closed head injury and/or spinal trauma
- Informed consent from next of kin or POA
Who cannot join
- Patients less than 18 or more than 80 years of age
- GCS of 3 with bilaterally fixed and dilated pupils
- Penetrating head trauma (e.g., gun shot wounds, nail gun injuries, etc.)
- Pregnant women
- Mentally impaired.
Trial locations and contacts
1 site in 1 country.
United States1 site
Scottsdale Healthcare Osborn
Scottsdale, Arizona, 85251
About this study
Official title: Clinical Utility of Propofol Sedations Without and With a Formal "ICU Sedation Protocol" in Intubated Neurotrauma Patients
Purpose of Protocol: The purpose of this study will be to compare the clinical utility of Propofol sedation with and without the use of the ICU Sedation Protocol. Patients will be treated according to the attending/consulting preference. No attempt will be made to influence the patient's routine care and management. The study will compare the average hourly infusion rates for the Propofol administration, as well as obtain the nursing staffs evaluation regarding the ease of neurological assessment during each 12 hour shift
Read the detailed description
Study Objectives and Design: Propofol is a short-acting sedative that is easily titratable, and is approved for use in ventilated patients. The clinical usefulness of continuous intravenous infusion of Propofol has been demonstrated in the management of ventilated ICU patients. In addition, its short duration of action permits repeated neurological assessments to be carried out in patients with neurotrauma.
Despite these benefits, Propofol is not without some drawbacks, including a lack of analgesic effects, dose dependent lowering of blood pressure, and significant expense. To address these issues, the PI developed an ICU Sedation Protocol that combines a titrated continuous infusion of intravenous morphine sulfate with the Propofol infusion to achieve the desired level of sedation. This ICU Sedation Protocol has been approved for use at Scottsdale Healthcare since 2004, and printed copies are available at all ICU nursing stations on the Osborn campus.
At the present time, the ICU Sedation Protocol is used regularly by only two of the five neurosurgeons that care for the neurotrauma patients at the Osborn campus. The remaining three neurosurgeons prefer to use a continuous Propofol infusion with intermittent doses of intravenous morphine sulfate.
The purpose of the study will be to compare the clinical utility of Propofol sedation with and without the use of the ICU Sedation Protocol. Patients will be treated according to the attending neurosurgeons preference. No attempt will be made to influence the patient's routine care and management. The study will compare the average hourly infusion rates for Propofol administration, as well as evaluating the difficulty of neurological assessment, and the ease of weaning to extubation.
This is a prospective, non-randomized, open treatment protocol open to ICU patients at Scottsdale Healthcare Osborn. Only patients with neurotrauma that require intubation will be eligible for enrollment. Patients will be treated according to the consulting neurosurgeons preference. No attempt will be made to influence the patient's routine care and management, as already stated. The choice of sedation type and use of the ICU Sedation Protocol will be at the consulting neurosurgeons discretion.
Involvement in the protocol will cease when continuous intravenous sedation is discontinued for more than 24 hours, the patient is extubated or undergoes tracheostomy, or is transferred from the ICU.
- Conditions
- Anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionSep 2010
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scottsdale Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Logan, Scottsdale Healthcare
- Investigators
- Joseph Zabramski, MD, Principal investigator, Scottsdale Healthcare Osborn - Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00597740
- Sponsor's protocol ID
- 2007-106
- Acronym
- SPIN
- Status last verified
- Dec 2013
- First submitted
- 9 Jan 2008
- Last updated
- 3 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of Propofol Sedations Without and With a Formal "ICU Sedation Protocol" in Intubated Neurotrauma Patients
- ClinicalTrials.gov ID
- NCT00597740
- Acronym / sponsor ID
- SPIN / 2007-106
- Conditions
- Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Scottsdale HealthcareUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 18 Jan 2008 (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.
Purpose of Protocol: The purpose of this study will be to compare the clinical utility of Propofol sedation with and without the use of the ICU Sedation Protocol. Patients will be treated according to the attending/consulting preference. No attempt will be made to influence the patient's routine care and management. The study will compare the average hourly infusion rates for the Propofol administration, as well as obtain the nursing staffs evaluation regarding the ease of neurological assessment during each 12 hour shift
Detailed description
Study Objectives and Design: Propofol is a short-acting sedative that is easily titratable, and is approved for use in ventilated patients. The clinical usefulness of continuous intravenous infusion of Propofol has been demonstrated in the management of ventilated ICU patients. In addition, its short duration of action permits repeated neurological assessments to be carried out in patients with neurotrauma.
Despite these benefits, Propofol is not without some drawbacks, including a lack of analgesic effects, dose dependent lowering of blood pressure, and significant expense. To address these issues, the PI developed an ICU Sedation Protocol that combines a titrated continuous infusion of intravenous morphine sulfate with the Propofol infusion to achieve the desired level of sedation. This ICU Sedation Protocol has been approved for use at Scottsdale Healthcare since 2004, and printed copies are available at all ICU nursing stations on the Osborn campus.
At the present time, the ICU Sedation Protocol is used regularly by only two of the five neurosurgeons that care for the neurotrauma patients at the Osborn campus. The remaining three neurosurgeons prefer to use a continuous Propofol infusion with intermittent doses of intravenous morphine sulfate.
The purpose of the study will be to compare the clinical utility of Propofol sedation with and without the use of the ICU Sedation Protocol. Patients will be treated according to the attending neurosurgeons preference. No attempt will be made to influence the patient's routine care and management. The study will compare the average hourly infusion rates for Propofol administration, as well as evaluating the difficulty of neurological assessment, and the ease of weaning to extubation.
This is a prospective, non-randomized, open treatment protocol open to ICU patients at Scottsdale Healthcare Osborn. Only patients with neurotrauma that require intubation will be eligible for enrollment. Patients will be treated according to the consulting neurosurgeons preference. No attempt will be made to influence the patient's routine care and management, as already stated. The choice of sedation type and use of the ICU Sedation Protocol will be at the consulting neurosurgeons discretion.
Involvement in the protocol will cease when continuous intravenous sedation is discontinued for more than 24 hours, the patient is extubated or undergoes tracheostomy, or is transferred from the ICU.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Neurotrauma ICU patients brought to our level one trauma facility requiring intubation.
Key inclusion criteria (5 listed)
- Ages 18-80 (inclusive)
- Admitted to trauma service
- Intubated and on respiratory support
- Neurosurgical consultation for closed head injury and/or spinal trauma
- Informed consent from next of kin or POA
Key exclusion criteria (5 listed)
- Patients less than 18 or more than 80 years of age
- GCS of 3 with bilaterally fixed and dilated pupils
- Penetrating head trauma (e.g., gun shot wounds, nail gun injuries, etc.)
- Pregnant women
- Mentally impaired.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 3 Dec 2013.
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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.
Joseph Zabramski, MD principal investigator
Scottsdale Healthcare Osborn - Neurosurgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, run by Scottsdale Healthcare 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 5 inclusion and 5 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 3 Dec 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 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.
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.
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 3 Dec 2013.