Blood PressureNCT01065350
A Comparison of Ketofol (Ketamine and Propofol Admixture) Versus Propofol as Induction Agents on Hemodynamic Parameters
A study testing Propofol and Ketamine in people with Blood Pressure, run by Mayo Clinic at 1 site in United States.
Trial summary
This is a pilot study to compare the hemodynamic changes that occur during induction with a novel drug combination known as ketofol (propofol and ketamine admixture with that of propofol alone (prototypic anesthesia induction agent). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Propofol and Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Mar 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- American Society of Anesthesiologists (ASA) physical status I and II who are to undergo elective general, urologic, orthopedic, plastic, or gynecologic surgery.
Who cannot join
- patients with age less than 18 yr or over 60 yr,
- emergency surgery,
- patients undergoing neurosurgical procedures,
- any procedure with adjunctive analgesia,
- any patient on chronic opiate use,
- females who are known to be pregnant,
Show all 10Show fewer
- patients who had ingested psychotropic or sedative medication within one month of investigation,
- patients with personality disorders,
- weight greater than 20% of ideal, and
- any known contraindications to ketamine or propofol.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: A Comparison of Ketofol (Ketamine and Propofol Admixture) vs. Propofol as Induction Agents on Hemodynamic Parameters
This is a pilot study to compare the hemodynamic changes that occur during induction with a novel drug combination known as ketofol (propofol and ketamine admixture with that of propofol alone (prototypic anesthesia induction agent). Propofol and ketamine are widely used as induction agents and their effects on patient hemodynamics are well known. Some of these drug-induced hemodynamic changes are undesirable and lead to deleterious effects on patient hemodynamics. We seek to investigate the hemodynamic changes associated with a novel drug combination known as ketofol (ketamine/propofol admixture) during induction and compare them to propofol. If we determine that the changes produced by ketofol are favorable compared with propofol, we then will seek to test its use in the trauma setting in a subsequent randomized controlled trial.
Read the detailed description
This is a pilot study to compare the hemodynamic changes that occur during induction with a novel drug combination known as ketofol with that of propofol. Propofol and ketamine are widely used as induction agents and their effects on patient hemodynamics are well known. Many of these drug-induced changes are undesirable and when used alone sometimes lead to hemodynamic effects on opposite ends of the spectrum, ie. hypotension (propofol) and hypertension (ketamine). We will investigate the hemodynamic changes associated with this drug combination referred to as "ketofol" (ketamine/propofol admixture) during induction compared with propofol as the gold standard induction agent used widely in anesthetic practice. If we validate that the changes produced by the ketofol admixture are favorable, we will then test its use in a wider setting of patient populations including emergency department intubations and the trauma setting.
Background: Propofol is a non-opioid, non-barbiturate, sedative-hypnotic agent with rapid onset and short duration of action. It possesses many favorable effects such as an antiemetic effect and reliably produces sedation and amnesia (Felfernig Jour of Royal Naval Medical Service, '06; White International Anesth Clinics, '88; Willman Ann of Emer Med, '07). However, there are several undesirable side effects such as cardiovascular and respiratory depression. In addition, Propofol as a sole agent has no analgesic properties. These drug-induced side effects have led to alternative drugs being used with the hopes of a more favorable side effect profile. Ketamine is an example of one such drug. Ketamine is a phencyclidine derivative commonly classified as a dissociative sedative with fairly rapid onset and short duration of action (Felfernig Jour of Royal Naval Medical Service, '06; White International Anesth Clinics, '88; Willman Ann of Emer Med, '07). It causes little or no respiratory and cardiovascular depression and unlike propofol, has pain relieving properties. Ketamine as a single induction agent, however, is limited by emergence phenomena including postoperative dreaming and hallucinations, however these are attenuated by the administration of benzodiazepines. Also ketamine in induction doses 1-4.5 mg/kg can have some undesirable effects on hemodynamics (opposite of propofol) in certain patient populations including ischemic heart disease (IHD), and patients with increases in intracranial hypertension and intracranial pressure (ICP). Effectiveness of the two agents in combination has been recently demonstrated and this new combination could allow a novel induction agent with favorable effects on hemodynamics (Felfernig Jour of Royal Naval Medical Service, '06; Hui Jour of Amer Soc of Anesth, '95; Willman Ann of Emer Med, '07). To date, this combination known as ketofol has been used most extensively for procedural sedation in the Emergency Department but has not yet been standardized as an induction agent. We are obtaining funding for a pilot study to validate the use of ketofol as an induction agent.
- Conditions
- Blood Pressure
- Keywords
- ketofol, hemodynamics, propofol, anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Diprivan
As part of the induction, subjects will be given 2 milligrams per kilogram of body weight (mg/kg) of propofol. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL. The clinician and observer will be blinded to the medication and doses being administered during induction given that both syringes, syringes in the propofol and ketofol groups, will look identical (will both appear to be propofol only). The propofol group will also be given an additional 10 mL syringe of propofol due to any patient responding to stimulus after induction. The 10 mL syringe represents 1 mg/kg of propofol. If patient receives both the 20 and 10ml syringe, he or she will receive a total of 3mg/kg of propofol.
KetamineDrug
Also called Ketalar
As part of the induction, patients will be given 20ml syringe of ketofol which is weight based such that ketamine will represent 0.75mg/kg of the dose and propofol, 1.5mg/kg. The clinician and observer will be blinded to the medication and doses being administered during induction given that both 20ml syringes (propofol group and ketofol group) will look identical (will both appear to be propofol only). Additional 10ml syringe will be given due to any patient responding to stimulus after induction. The 10ml syringe will represent 0.25mg/kg of ketamine and 0.5mg/kg of propofol. If the patient receives both the 20 and 10ml rescue syringe, he or she will receive a total of 1mg/kg of ketamine and 2mg/kg of propofol.
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Active comparator | As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL. Receives: Drug: Propofol |
| Ketofol | Experimental | As part of the induction, patients will be given 20 mL syringe of an admixture called "ketofol," which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose. Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Subjects With a Greater Than 20% Decrease in Systolic Blood Pressure (SBP) Following Induction of General Anesthesia
Blood pressure was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The percentage of subjects experiencing decreases in SBP of greater than 20% during the specified time intervals is reported, as compared to the baseline systolic blood pressure reading. There are two numbers in a blood pressure reading, and they are expressed in millimeters of mercury (mm Hg). This tells how high in millimeters the pressure of your blood raises a column of mercury. The numbers usually are expressed in the form of a fraction; an example of a blood pressure reading is 120/80 mm Hg. The first, or top, number (120 in the example) is the systolic pressure. The systolic pressure is the measure of your blood pressure as the heart contracts and pumps blood.
Measured: Baseline, 5 minutes, 10 minutes, 30 minutes post induction
Secondary outcomes (13)
Percent of Subjects With a Greater Than 20% Decrease in Diastolic Blood Pressure (DBP) Following Induction of General Anesthesia
Blood pressure was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The percentage of subjects experiencing decreases in DBP of greater than 20% during the specified time intervals is reported, as compared to the baseline DBP reading. The second or lower number of a blood pressure reading is the DBP and is the measure taken when your heart is at rest.
Measured: Baseline, 5 minutes, 10 minutes, 30 minutes post induction
Percent of Subjects With a Greater Than 20% Decrease in Mean Arterial Pressure (MAP) Following Induction of General Anesthesia
MAP was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The percentage of subjects experiencing decreases in MAP of greater than 20% during the specified time intervals is reported, as compared to the baseline MAP reading.
Measured: Baseline, 5 minutes, 10 minutes, 30 minutes post induction
Average Change in Cardiac Output (CO)
CO was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in CO as compared to baseline CO during the specified time intervals is reported.
CO is defined as the quantity of blood ejected per minute by the heart into the systemic circulation. It is the product of the heart rate (HR) (beats per minute) times the stroke volume (SV) (milliliters of blood ejected during each contraction).
Measured: Baseline, 5 minutes, 10 minutes post induction
Average Change in Cardiac Index (CI)
CI was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in CI as compared to the baseline CI during the specified time intervals is reported.
To determine CI, cardiac output is divided by the body surface area in order to account for body size.
Measured: Baseline, 5 minutes, 10 minutes post induction
Average Change in Heart Rate (HR)
HR was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in HR (as compared to baseline HR) during the specified time intervals is reported.
Measured: Baseline, 5 minutes, 10 minutes post induction
Average Change in Systolic Blood Pressure (SBP)
Blood pressure was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in SBP (as compared to baseline SBP) during the specified time intervals is reported.
Measured: Baseline, 5 minutes, 10 minutes post induction
Average Change in Diastolic Blood Pressure (DBP)
Blood pressure was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in DBP (as compared to baseline DBP) during the specified time intervals is reported.
Measured: Baseline, 5 minutes, 10 minutes post induction
Average Change in Mean Arterial Pressure (MAP)
MAP was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in MAP from baseline during the specified time intervals is reported.
MAP is a term used in medicine to describe an average blood pressure in an individual. It is defined as the average arterial pressure during a single cardiac cycle.
Measured: Baseline, 5 minutes, 10 minutes post induction
Average Change in Total Peripheral Resistance (TPR)
TPR was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in TPR from baseline during the specified time intervals is reported. TPR is the overall resistance to blood flow through the systemic blood vessels.
Measured: Baseline, 5 minutes, 10 minutes post induction
Average Change in Total Peripheral Resistance Index (TPRI)
TPRI was recorded every minute for a total of 30 minutes after anesthesia was induced and results were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in TPRI from baseline during the specified time intervals is reported.
Measured: Baseline, 5 minutes, 10 minutes post induction
Average Change in Stroke Volume (SV)
SV was recorded every minute for a total of 30 minutes after anesthesia was induced and results were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in SV from baseline during the specified time intervals is reported. SV is the milliliters of blood ejected during each contraction of the heart.
Measured: Baseline, 5 minutes, 10 minutes post induction
Average Change in Stroke Volume Index (SVI)
SVI was recorded every minute for a total of 30 minutes after anesthesia was induced and results were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The average change in SVI (as compared to baseline SVI) during the specified time intervals is reported. To determine SVI, stroke volume is divided by the body surface area in order to account for body size.
Measured: Baseline, 5 minutes, 10 minutes post induction
Average Change in Stroke Volume Variation (SVV)
SVV was recorded every minute for a total of 30 minutes after anesthesia was induced and results were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. SVV is a dynamic flow-based parameter and together with cardiac output provides an indication of fluid responsiveness. The average change in SVV (as compared to baseline SVV) during the specified time intervals is reported. SVV is calculated by taking the SVmax - SVmin /*100/ SV mean.
Measured: Baseline, 5 minutes, 10 minutes post induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startDec 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth-Hitchcock Medical Center
- Responsible party
- Principal investigator, Nathan J. Smischney, Mayo Clinic
- Investigators
- Nathan J Smischney, MD, Principal investigator, Mayo ClinicMatthew Koff, MD, Study director, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01065350
- Sponsor's protocol ID
- 22063
- Status last verified
- Mar 2013
- First submitted
- 7 Feb 2010
- Last updated
- 3 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Smischney NJ, Beach ML, Loftus RW, Dodds TM, Koff MD. Ketamine/propofol admixture (ketofol) is associated with improved hemodynamics as an induction agent: a randomized, controlled trial. J Trauma Acute Care Surg. 2012 Jul;73(1):94-101. doi: 10.1097/TA.0b013e318250cdb8.
PubMed 22743378
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Ketofol (Ketamine and Propofol Admixture) vs. Propofol as Induction Agents on Hemodynamic Parameters
- ClinicalTrials.gov ID
- NCT01065350
- Acronym / sponsor ID
- 22063
- Conditions
- Blood Pressure
- Keywords
- ketofol, hemodynamics, propofol, anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Dartmouth-Hitchcock Medical Center
- Study start
- Dec 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 9 Feb 2010 (estimated)
- Results
- Posted 3 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study to compare the hemodynamic changes that occur during induction with a novel drug combination known as ketofol (propofol and ketamine admixture with that of propofol alone (prototypic anesthesia induction agent). Propofol and ketamine are widely used as induction agents and their effects on patient hemodynamics are well known. Some of these drug-induced hemodynamic changes are undesirable and lead to deleterious effects on patient hemodynamics. We seek to investigate the hemodynamic changes associated with a novel drug combination known as ketofol (ketamine/propofol admixture) during induction and compare them to propofol. If we determine that the changes produced by ketofol are favorable compared with propofol, we then will seek to test its use in the trauma setting in a subsequent randomized controlled trial.
Detailed description
This is a pilot study to compare the hemodynamic changes that occur during induction with a novel drug combination known as ketofol with that of propofol. Propofol and ketamine are widely used as induction agents and their effects on patient hemodynamics are well known. Many of these drug-induced changes are undesirable and when used alone sometimes lead to hemodynamic effects on opposite ends of the spectrum, ie. hypotension (propofol) and hypertension (ketamine). We will investigate the hemodynamic changes associated with this drug combination referred to as "ketofol" (ketamine/propofol admixture) during induction compared with propofol as the gold standard induction agent used widely in anesthetic practice. If we validate that the changes produced by the ketofol admixture are favorable, we will then test its use in a wider setting of patient populations including emergency department intubations and the trauma setting.
Background: Propofol is a non-opioid, non-barbiturate, sedative-hypnotic agent with rapid onset and short duration of action. It possesses many favorable effects such as an antiemetic effect and reliably produces sedation and amnesia (Felfernig Jour of Royal Naval Medical Service, '06; White International Anesth Clinics, '88; Willman Ann of Emer Med, '07). However, there are several undesirable side effects such as cardiovascular and respiratory depression. In addition, Propofol as a sole agent has no analgesic properties. These drug-induced side effects have led to alternative drugs being used with the hopes of a more favorable side effect profile. Ketamine is an example of one such drug. Ketamine is a phencyclidine derivative commonly classified as a dissociative sedative with fairly rapid onset and short duration of action (Felfernig Jour of Royal Naval Medical Service, '06; White International Anesth Clinics, '88; Willman Ann of Emer Med, '07). It causes little or no respiratory and cardiovascular depression and unlike propofol, has pain relieving properties. Ketamine as a single induction agent, however, is limited by emergence phenomena including postoperative dreaming and hallucinations, however these are attenuated by the administration of benzodiazepines. Also ketamine in induction doses 1-4.5 mg/kg can have some undesirable effects on hemodynamics (opposite of propofol) in certain patient populations including ischemic heart disease (IHD), and patients with increases in intracranial hypertension and intracranial pressure (ICP). Effectiveness of the two agents in combination has been recently demonstrated and this new combination could allow a novel induction agent with favorable effects on hemodynamics (Felfernig Jour of Royal Naval Medical Service, '06; Hui Jour of Amer Soc of Anesth, '95; Willman Ann of Emer Med, '07). To date, this combination known as ketofol has been used most extensively for procedural sedation in the Emergency Department but has not yet been standardized as an induction agent. We are obtaining funding for a pilot study to validate the use of ketofol as an induction agent.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Active comparator | Drug: PropofolAs part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL. |
| Ketofol | Experimental | Drug: KetamineAs part of the induction, patients will be given 20 mL syringe of an admixture called "ketofol," which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) physical status I and II who are to undergo elective general, urologic, orthopedic, plastic, or gynecologic surgery.
Key exclusion criteria (10 listed)
- patients with age less than 18 yr or over 60 yr,
- emergency surgery,
- patients undergoing neurosurgical procedures,
- any procedure with adjunctive analgesia,
- any patient on chronic opiate use,
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 |
|---|---|---|
| PropofolAlso: DiprivanAs part of the induction, subjects will be given 2 milligrams per kilogram of body weight (mg/kg) of propofol. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL. The clinician and observer will be blinded to the medication and doses being administered during induction given that both syringes, syringes in the propofol and ketofol groups, will look identical (will both appear to be propofol only). The propofol group will also be given an additional 10 mL syringe of propofol due to any patient responding to stimulus after induction. The 10 mL syringe represents 1 mg/kg of propofol. If patient receives both the 20 and 10ml syringe, he or she will receive a total of 3mg/kg of propofol. | Drug | Propofol |
| KetamineAlso: KetalarAs part of the induction, patients will be given 20ml syringe of ketofol which is weight based such that ketamine will represent 0.75mg/kg of the dose and propofol, 1.5mg/kg. The clinician and observer will be blinded to the medication and doses being administered during induction given that both 20ml syringes (propofol group and ketofol group) will look identical (will both appear to be propofol only). Additional 10ml syringe will be given due to any patient responding to stimulus after induction. The 10ml syringe will represent 0.25mg/kg of ketamine and 0.5mg/kg of propofol. If the patient receives both the 20 and 10ml rescue syringe, he or she will receive a total of 1mg/kg of ketamine and 2mg/kg of propofol. | Drug | Ketofol |
Primary outcome
Percent of Subjects With a Greater Than 20% Decrease in Systolic Blood Pressure (SBP) Following Induction of General Anesthesia
Time frame: Baseline, 5 minutes, 10 minutes, 30 minutes post induction
Blood pressure was recorded every minute for a total of 30 minutes after anesthesia was induced and readings were captured via a Non-Invasive Cardiac Output Monitor [NICOM], Cheetah Medical, Israel. The percentage of subjects experiencing decreases in SBP of greater than 20% during the specified time intervals is reported, as compared to the baseline systolic blood pressure reading. There are two numbers in a blood pressure reading, and they are expressed in millimeters of mercury (mm Hg). This tells how high in millimeters the pressure of your blood raises a column of mercury. The numbers usually are expressed in the form of a fraction; an example of a blood pressure reading is 120/80 mm Hg. The first, or top, number (120 in the example) is the systolic pressure. The systolic pressure is the measure of your blood pressure as the heart contracts and pumps blood.
13 secondary outcomes
Percent of Subjects With a Greater Than 20% Decrease in Diastolic Blood Pressure (DBP) Following Induction of General Anesthesia
Time frame: Baseline, 5 minutes, 10 minutes, 30 minutes post induction
Percent of Subjects With a Greater Than 20% Decrease in Mean Arterial Pressure (MAP) Following Induction of General Anesthesia
Time frame: Baseline, 5 minutes, 10 minutes, 30 minutes post induction
Average Change in Cardiac Output (CO)
Time frame: Baseline, 5 minutes, 10 minutes post induction
Average Change in Cardiac Index (CI)
Time frame: Baseline, 5 minutes, 10 minutes post induction
Average Change in Heart Rate (HR)
Time frame: Baseline, 5 minutes, 10 minutes post induction
Average Change in Systolic Blood Pressure (SBP)
Time frame: Baseline, 5 minutes, 10 minutes post induction
Average Change in Diastolic Blood Pressure (DBP)
Time frame: Baseline, 5 minutes, 10 minutes post induction
Average Change in Mean Arterial Pressure (MAP)
Time frame: Baseline, 5 minutes, 10 minutes post induction
Average Change in Total Peripheral Resistance (TPR)
Time frame: Baseline, 5 minutes, 10 minutes post induction
Average Change in Total Peripheral Resistance Index (TPRI)
Time frame: Baseline, 5 minutes, 10 minutes post induction
Average Change in Stroke Volume (SV)
Time frame: Baseline, 5 minutes, 10 minutes post induction
Average Change in Stroke Volume Index (SVI)
Time frame: Baseline, 5 minutes, 10 minutes post induction
Average Change in Stroke Volume Variation (SVV)
Time frame: Baseline, 5 minutes, 10 minutes post induction
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22743378Smischney NJ, Beach ML, Loftus RW, Dodds TM, Koff MD. Ketamine/propofol admixture (ketofol) is associated with improved hemodynamics as an induction agent: a randomized, controlled trial. J Trauma Acute Care Surg. 2012 Jul;73(1):94-101. doi: 10.1097/TA.0b013e318250cdb8.
Related trials for Blood Pressure
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
Not yet recruiting
Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior
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.
Nathan J Smischney, MD principal investigator
Mayo Clinic
Matthew Koff, MD study director
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol and Ketamine in people with Blood Pressure, run by Mayo Clinic 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 10 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 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 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?
Yes. Results are posted in the registry (first posted 3 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent of Subjects With a Greater Than 20% Decrease in Systolic Blood Pressure (SBP) Following Induction of General Anesthesia (time frame: Baseline, 5 minutes, 10 minutes, 30 minutes post induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01065350, which also lists 1 linked publication.
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 May 2013.