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A Safety and Efficacy Study of Dexmedetomidine in Patients Requiring Sedation During Monitored Anesthesia Care (MAC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00398827
First Posted: November 14, 2006
Last Update Posted: July 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospira, now a wholly owned subsidiary of Pfizer
  Purpose
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).

Condition Intervention Phase
Anesthesia Surgical Procedures, Elective Drug: Dexmedetomidine Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Dexmedetomidine for Sedation During Monitored Anesthesia Care

Resource links provided by NLM:


Further study details as provided by Hospira, now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • 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])


Secondary Outcome Measures:
  • 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 ]
    Subjects who are not adequately sedated (OAA/S is >4) may receive rescue MDZ (after attempting to achieve sedation via study drug titration).

  • 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. ]
    Assessed by time from discontinuation of study drug to reach Aldrete score ≥9.

  • 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 ]

Enrollment: 326
Study Start Date: December 2006
Study Completion Date: May 2007
Arms Assigned Interventions
Experimental: Dexmedetomidine 0.5 mcg/kg load Drug: Dexmedetomidine
Experimental: Dexmedetomidine 1 mcg/kg load Drug: Dexmedetomidine
Placebo Comparator: Placebo Drug: Placebo

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

    1. 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.
    2. 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00398827


  Show 27 Study Locations
Sponsors and Collaborators
Hospira, now a wholly owned subsidiary of Pfizer
  More Information

Responsible Party: Hospira, now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00398827     History of Changes
Other Study ID Numbers: 2005-005
First Submitted: November 10, 2006
First Posted: November 14, 2006
Last Update Posted: July 23, 2015
Last Verified: July 2015

Keywords provided by Hospira, now a wholly owned subsidiary of Pfizer:
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

Additional relevant MeSH terms:
Anesthetics
Dexmedetomidine
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action