AnesthesiaPhase 3NCT00398827
A Safety and Efficacy Study of Dexmedetomidine in Patients Requiring Sedation During Monitored Anesthesia Care (MAC)
A Phase 3 study testing Dexmedetomidine in people with Anesthesia and Surgical Procedures, Elective, run by Hospira, now a wholly owned subsidiary of Pfizer at 27 sites in United States.
Trial summary
The objective of this study is to evaluate the safety and efficacy of dexmedetomidine as compared to placebo when used for the sedation of subjects requiring monitored anesthesia care (MAC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Surgical Procedures, Elective
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 326 participants
- Where
- 27 sitesUnited States
- Study dates
- Dec 2006to May 2007
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (≥18 years of age)
- American Society of Anesthesiologists (ASA) Physical Status I, II, III, or IV.
- If female, subject is non-lactating and is either:
- Not of childbearing potential, defined as post-menopausal for at least 1 year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy or hysterectomy.
- Of childbearing potential but is not pregnant at time of baseline and is practicing one of the following methods of birth control: oral or parenteral contraceptives, double-barrier method, vasectomized partner, or abstinence from sexual intercourse.
- Subject requires monitored anesthesia care (MAC) in an operating room (OR) or procedure room with an anesthesiologist in attendance.
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- Subject requires one of the following types of elective surgeries/procedures expected to take longer than 30 minutes:
- Orthopedic
- Ophthalmic
- Plastic
- Vascular stents
- Breast biopsies
- AV fistulas
- Excision of lesion.
- Subject requires local anesthetic block.
- Subject (or subject's legally authorized representative) has voluntarily signed and dated the informed consent document approved by the Institutional Review Board.
Who cannot join
- Subject has received general anesthesia within 7 days prior to study entry, has received any experimental drug within 30 days prior to study drug administration, or has been previously enrolled in this study.
- Subject requires endotracheal intubation or laryngeal mask airway (LMA)
- Subject has central nervous system (CNS) disease with an anticipated potential for increased intracranial pressure, an uncontrolled seizure disorder, and/or known psychiatric illness that could confound a normal response to sedative treatment.
- Subject requires epidural or spinal anesthesia.
- Subject has received treatment with an alpha-2 agonist or antagonist within 14 days of the scheduled surgery/procedure.
- Subject for whom opiates, benzodiazepines, dexmedetomidine, or other alpha-2 agonists are contraindicated.
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- Subject has received an intravenous (IV) opioid within one hour, or a by mouth (PO)/intramuscular (IM) opioid within 4 hours, of the start of study drug administration.
- Subject has acute unstable angina, acute myocardial infarction documented by laboratory findings in the past 6 weeks, heart rate <50 bpm, systolic blood pressure (SBP) <90 mmHg, or third-degree heart block unless patient has a pacemaker.
- Subject has known elevated serum glutamic pyruvic transaminase (SGPT/Alanine aminotransferase [ALT]) and/or serum glutamic oxaloacetic transaminase (SGOT/aspartate Aminotransferase [AST]) values of ≥2 times the upper limit of normal within the 2 months prior to screening, and/or a history of liver failure.
- Subject has any other condition or factor which, in the Investigator's opinion, might increase the risk to the subject.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287-0712
University of Alabama
Birmingham, Alabama, 35294
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia
Charlottesville, Virginia, 22908-0710
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
University of Missouri Health Care
Columbia, Missouri, 65212
The Ohio State University
Columbus, Ohio, 43210-1228
Dallas VA Medical Center
Dallas, Texas, 75216
Baylor Research Institute
Dallas, Texas, 75246
VAMC
Durham, North Carolina, 27705
Duke University
Durham, North Carolina, 27710
MD Anderson Cancer Center
Houston, Texas, 77030
Loma Linda Medical Center
Loma Linda, California, 92354
Jackson Memorial Hospital
Miami, Florida, 33136
University of Miami
Miami, Florida, 33136
South Miami Hospital
Miami, Florida, 33143
VA Medical Center
Milwaukee, Wisconsin, 53295
NYU School of Medicine
New York, New York, 10016
Mount Sinai School of Medicine
New York, New York, 10029
Crossroads Research Inc.
Owings Mills, Maryland, 21117
Chesapeake Research Group
Pasadena, Maryland, 21122
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
William Beaumont Hospital
Royal Oak, Michigan, 48073
SUNY Upstate Medical Center
Syracuse, New York, 13210
Scott & White Memorial Hospital
Temple, Texas, 76508
About this study
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Dexmedetomidine for Sedation During Monitored Anesthesia Care
The objective of this study is to evaluate the safety and efficacy of dexmedetomidine as compared to placebo when used for the sedation of subjects requiring monitored anesthesia care (MAC).
Read the detailed description
Monitored anesthesia care (MAC) is a specific anesthesia service that involves an anesthesiologist administering sedatives and analgesics to a patient while monitoring his/her vital signs. MAC is often used to supplement local and regional anesthesia for non-intubated patients undergoing non-invasive procedures and minor surgery. The goal of MAC is to relieve anxiety by inducing a minimally depressed level of consciousness while the patient is able to continuously and independently maintain a patent airway and to respond appropriately to verbal commands.
Respiratory depression is the major concern with most of the medications (midazolam, fentanyl, propofol) currently used for MAC. There is clearly an unmet need for a sedative agent that can safely be used during MAC in both healthy and high risk populations with limited adverse side effects. A medication that can attenuate anxiety and the stress response associated with surgery and procedures without causing respiratory depression is highly desirable. A medication that reduces the total amount of opioids administered during a procedure could substantially reduce complications. Such a medication could be used either alone or in combination with other agents, thereby reducing the dose and side effects of the other agents.
Dexmedetomidine (DEX) has sympatholytic, sedative, analgesic, and anxiolytic effects that attenuate the catecholamine response to perioperative stress. DEX has not been associated with respiratory depression when used alone, despite sometimes deep levels of sedation.
An estimated 325 patients (260 DEX, 65 PBO) requiring MAC sedation for an elective surgery/procedure will be randomized at approximately 25 investigative sites.
- Conditions
- Anesthesia, Surgical Procedures, Elective
- Being tested
- Dexmedetomidine, Placebo
- Keywords
- American Society of Anesthesiologists (ASA), Observer's Assessment of Alertness Scale (OAA/S), Aldrete Scoring System, Surgery or procedure using monitored care anesthesia, Surgery or procedure at least 30 minutes in duration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine 0.5 mcg/kg load | Experimental | Not described Receives: Drug: Dexmedetomidine |
| Dexmedetomidine 1 mcg/kg load | Experimental | Not described Receives: Drug: Dexmedetomidine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of patients not requiring midazolam for rescue sedation based on achieving and/or maintaining an Observer's Assessment of Alertness/Sedation Scale (OAA/S) score ≤4
Observer's Assessment of Alertness/Sedation Scale (OAA/S) score ≤4 (Responsiveness: Lethargic response to name spoken in normal tone; Speech: Mild slowing or thickening; Facial Expression: Mild relaxation; Eyes: Glazed or mild ptosis [less than half the eye])
Measured: Prior to start of study drug, 15 minutes after start of study drug infusion, every 5 minutes thereafter throughout the study drug infusion and every 15 minutes while the subject is in the post anesthesia care unit.
Secondary outcomes (9)
Total amount (mg) of rescue midazolam required to achieve and/or maintain sedation (OAA/S score ≤4)
Measured: Prior to start of study drug, 15 minutes after start of study drug infusion, every 5 minutes thereafter throughout the study drug infusion and every 15 minutes while the subject is in the post anesthesia care unit.
Time from onset of study drug infusion to first dose of rescue midazolam
Subjects who are not adequately sedated (OAA/S is >4) may receive rescue MDZ (after attempting to achieve sedation via study drug titration).
Measured: After the first 15 minutes of study drug infusion
Percentage of subjects who convert to alternative sedative and/or anesthetic therapy due to failure of treatment with study drug and rescue
Measured: Prior to start of study drug, 15 minutes after start of study drug infusion, every 5 minutes thereafter throughout the study drug infusion and every 15 minutes while the subject is in the post anesthesia care unit.
Time to recovery and readiness for discharge from Post-Anesthesia Care Unit (PACU)
Assessed by time from discontinuation of study drug to reach Aldrete score ≥9.
Measured: Performed every 15 minutes while the subject is in the PACU until subject is discharged.
Total amount of fentanyl required for pain control
Measured: After the first 15 minutes of study drug infusion
Anesthesiologist assessment of ease of management
Measured: Approximately 24 hours
Anesthesiologist assessment of subject cooperation
Measured: Approximately 24 hours
Incidence of post-operative nausea and vomiting (PONV) in the PACU and during the 24 hour follow up
Measured: Approximately 24 hours
Overall Subject satisfaction and anxiety assessed 24 hours after study drug has been discontinued
Measured: 24 hours after study drug has been discontinued
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2006 (estimated)
- Study startDec 2006
- Study completionMay 2007
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00398827
- Sponsor's protocol ID
- 2005-005
- Status last verified
- Jul 2015
- First submitted
- 10 Nov 2006
- Last updated
- 23 Jul 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Dexmedetomidine for Sedation During Monitored Anesthesia Care
- ClinicalTrials.gov ID
- NCT00398827
- Acronym / sponsor ID
- 2005-005
- Conditions
- Anesthesia, Surgical Procedures, Elective
- Keywords
- American Society of Anesthesiologists (ASA), Observer's Assessment of Alertness Scale (OAA/S), Aldrete Scoring System, Surgery or procedure using monitored care anesthesia, Surgery or procedure at least 30 minutes in duration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Hospira, now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Study completion
- May 2007 (actual)
- First posted
- 14 Nov 2006 (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 objective of this study is to evaluate the safety and efficacy of dexmedetomidine as compared to placebo when used for the sedation of subjects requiring monitored anesthesia care (MAC).
Detailed description
Monitored anesthesia care (MAC) is a specific anesthesia service that involves an anesthesiologist administering sedatives and analgesics to a patient while monitoring his/her vital signs. MAC is often used to supplement local and regional anesthesia for non-intubated patients undergoing non-invasive procedures and minor surgery. The goal of MAC is to relieve anxiety by inducing a minimally depressed level of consciousness while the patient is able to continuously and independently maintain a patent airway and to respond appropriately to verbal commands.
Respiratory depression is the major concern with most of the medications (midazolam, fentanyl, propofol) currently used for MAC. There is clearly an unmet need for a sedative agent that can safely be used during MAC in both healthy and high risk populations with limited adverse side effects. A medication that can attenuate anxiety and the stress response associated with surgery and procedures without causing respiratory depression is highly desirable. A medication that reduces the total amount of opioids administered during a procedure could substantially reduce complications. Such a medication could be used either alone or in combination with other agents, thereby reducing the dose and side effects of the other agents.
Dexmedetomidine (DEX) has sympatholytic, sedative, analgesic, and anxiolytic effects that attenuate the catecholamine response to perioperative stress. DEX has not been associated with respiratory depression when used alone, despite sometimes deep levels of sedation.
An estimated 325 patients (260 DEX, 65 PBO) requiring MAC sedation for an elective surgery/procedure will be randomized at approximately 25 investigative sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine 0.5 mcg/kg load | Experimental | Drug: Dexmedetomidine |
| Dexmedetomidine 1 mcg/kg load | Experimental | Drug: Dexmedetomidine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Adult (≥18 years of age)
- American Society of Anesthesiologists (ASA) Physical Status I, II, III, or IV.
- If female, subject is non-lactating and is either:
- Subject requires monitored anesthesia care (MAC) in an operating room (OR) or procedure room with an anesthesiologist in attendance.
- Subject requires one of the following types of elective surgeries/procedures expected to take longer than 30 minutes:
Key exclusion criteria (10 listed)
- Subject has received general anesthesia within 7 days prior to study entry, has received any experimental drug within 30 days prior to study drug administration, or has been previously enrolled in this study.
- Subject requires endotracheal intubation or laryngeal mask airway (LMA)
- Subject has central nervous system (CNS) disease with an anticipated potential for increased intracranial pressure, an uncontrolled seizure disorder, and/or known psychiatric illness that could confound a normal response to sedative treatment.
- Subject requires epidural or spinal anesthesia.
- Subject has received treatment with an alpha-2 agonist or antagonist within 14 days of the scheduled surgery/procedure.
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 |
|---|---|---|
| Dexmedetomidine | Drug | Dexmedetomidine 0.5 mcg/kg load, Dexmedetomidine 1 mcg/kg load |
| Placebo | Drug | Placebo |
Primary outcome
Percent of patients not requiring midazolam for rescue sedation based on achieving and/or maintaining an Observer's Assessment of Alertness/Sedation Scale (OAA/S) score ≤4
Time frame: Prior to start of study drug, 15 minutes after start of study drug infusion, every 5 minutes thereafter throughout the study drug infusion and every 15 minutes while the subject is in the post anesthesia care unit.
Observer's Assessment of Alertness/Sedation Scale (OAA/S) score ≤4 (Responsiveness: Lethargic response to name spoken in normal tone; Speech: Mild slowing or thickening; Facial Expression: Mild relaxation; Eyes: Glazed or mild ptosis [less than half the eye])
9 secondary outcomes
Total amount (mg) of rescue midazolam required to achieve and/or maintain sedation (OAA/S score ≤4)
Time frame: Prior to start of study drug, 15 minutes after start of study drug infusion, every 5 minutes thereafter throughout the study drug infusion and every 15 minutes while the subject is in the post anesthesia care unit.
Time from onset of study drug infusion to first dose of rescue midazolam
Time frame: After the first 15 minutes of study drug infusion
Percentage of subjects who convert to alternative sedative and/or anesthetic therapy due to failure of treatment with study drug and rescue
Time frame: Prior to start of study drug, 15 minutes after start of study drug infusion, every 5 minutes thereafter throughout the study drug infusion and every 15 minutes while the subject is in the post anesthesia care unit.
Time to recovery and readiness for discharge from Post-Anesthesia Care Unit (PACU)
Time frame: Performed every 15 minutes while the subject is in the PACU until subject is discharged.
Total amount of fentanyl required for pain control
Time frame: After the first 15 minutes of study drug infusion
Anesthesiologist assessment of ease of management
Time frame: Approximately 24 hours
Anesthesiologist assessment of subject cooperation
Time frame: Approximately 24 hours
Incidence of post-operative nausea and vomiting (PONV) in the PACU and during the 24 hour follow up
Time frame: Approximately 24 hours
Overall Subject satisfaction and anxiety assessed 24 hours after study drug has been discontinued
Time frame: 24 hours after study drug has been discontinued
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 23 Jul 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine in people with Anesthesia and Surgical Procedures, Elective, run by Hospira, now a wholly owned subsidiary of Pfizer at 27 sites 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 16 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 23 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites 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. 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 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?
Percent of patients not requiring midazolam for rescue sedation based on achieving and/or maintaining an Observer's Assessment of Alertness/Sedation Scale (OAA/S) score ≤4 (time frame: Prior to start of study drug, 15 minutes after start of study drug infusion, every 5 minutes thereafter throughout the study drug infusion and every 15 minutes while the subject is in the post anesthesia care unit.). 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 23 Jul 2015.