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

This study has been completed.
Sponsor:
Information provided by:
Hospira, Inc.
ClinicalTrials.gov Identifier:
NCT00398827
First received: November 10, 2006
Last updated: October 8, 2007
Last verified: October 2007
  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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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, Inc.:

Primary Outcome Measures:
  • The 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

Secondary Outcome Measures:
  • Total amount (mg) of rescue midazolam required to achieve and/or maintain sedation (OAA/S score < 4)
  • time from onset of study drug infusion to first dose of rescue midazolam
  • percentage of subjects who convert to alternative sedative and/or anesthetic therapy due to failure of treatment with study drug and rescue
  • time to recovery and readiness for discharge from Post-Anesthesia Care Unit (PACU)
  • total amount of fentanyl required for pain control
  • anesthesiologist assessment of ease of management
  • subject cooperation
  • incidence of post-operative nausea and vomiting in the PACU
  • subject satisfaction and anxiety assessed 24 hours after study drug

Estimated Enrollment: 325
Study Start Date: December 2006
Study Completion Date: May 2007
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (> 18 years of age)
  • American Society of Anesthesiologists (ASA) Physical Status I, II, III, or IV
  • Subject requires MAC in an operating room (OR) or procedure room with an anesthesiologist in attendance
  • Subject requires an elective surgery/procedure expected to take longer than 30 minutes
  • Subject requires local anesthetic block

Exclusion Criteria:

  • Exposure to any experimental drug within 30 days prior to study drug administration
  • Requires endotracheal intubation or laryngeal mask airway (LMA)
  • 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
  • Requires epidural or spinal anesthesia
  • Received treatment with an alpha-2 agonist or antagonist within 14 days of the scheduled surgery/procedure
  • Subject for whom opiates, benzodiazepines, DEX, 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 four hours, of the start of study drug administration
  • Subject has acute unstable angina, acute myocardial infarction documented by laboratory findings in the past six 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 SGPT (ALT) and/or SGOT (AST) values of > 2 times the upper limit of normal (ULN) within the two 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398827

  Show 27 Study Locations
Sponsors and Collaborators
Hospira, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00398827     History of Changes
Other Study ID Numbers: 2005-005
Study First Received: November 10, 2006
Last Updated: October 8, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Hospira, Inc.:
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
Midazolam
Fentanyl
Dexmedetomidine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents

ClinicalTrials.gov processed this record on August 20, 2014