Awake Intubation - Precedex Used for Sedation During Elective Awake Fiberoptic Intubation

Condition(s) targeted: Awake Fiberoptic Intubation

Intervention: Dexmedetomidine (Precedex) (Drug); Placebo (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Bernhard Riedel, MD, Principal Investigator, Affiliation: U.T.M.D. Anderson Cancer Center

The objective of this study is to evaluate the safety and efficacy of dexmedetomidine versus placebo used for sedation during elective awake fiberoptic intubation.

Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Dexmedetomidine Used for Sedation During Elective Awake Fiberoptic Intubation

Study design: Interventional, Supportive Care, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Detailed description: You will be having surgery and will need to be intubated before surgery in order to help protect your airway (everything from your lips to your windpipe) and to assist your breathing during surgery.

Intubation involves the placement of a breathing tube in your trachea (windpipe) while you are under anesthesia. Your doctor thinks it may be safer for the tube to be placed before anesthesia, while you are sedated (calmed with sedation medication) or awake. Your doctor will explain these reasons in detail. A flexible fiber-optic endoscope (a thin flexible tube) will be used to insert the tube into your throat. The purpose of dexmedetomidine is to help keep you calm and more comfortable while the tube is being inserted. You will then be placed under anesthesia before your surgery begins.

Dexmedetomidine is a drug used as a sedative for patients who are intubated.

Before you can start on this study, you will have "screening tests. ” These tests will help the doctor decide if you are eligible to take part in this study. Within 14 days before the start of this study, you will have your medical history recorded. You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate) and a routine exam of your throat and mouth. You will be asked about any drugs you may have been taking recently, including vitamins and/or food supplements.

On the day of surgery you will have an electrocardiogram (ECG - - a test that measures the electrical activity of the heart) done. You will again be asked about any drugs you may have been taking recently, and your vital signs will be measured. Your doctor will check your level of sedation (calmness). You will have the level of oxygen in your body measured. This is done by placing a probe that shines light onto one of your fingers, which is done routinely in surgeries. You will have blood drawn (about 1 ½ teaspoons) for routine tests. Your temperature will be taken. Women who are able to have children will have a urine pregnancy test performed. To be eligible to take part in this study, the pregnancy test must be negative.

If you are found to be eligible to take part in this study, you will be randomly assigned (like flipping a coin) to 1 of 2 groups. You will have an equal chance of being in either one of the groups. Neither you nor your doctor will know which group you are assigned to. However, in the event of an emergency, for your safety your doctor will be informed about what you are receiving. Participants in one group will receive dexmedetomidine. Participants in the other group will receive a placebo (a substance that looks like the study drug but has no active ingredients).

While you are on this study, you should tell the study staff about any side effects or medical problems that you may experience during this study. You should also not take part in any other research studies while you are on this study. This is to help protect you from possible injury from such things as extra blood drawing and possible negative drug interactions.

If you decide to withdraw from this study, the study drug or placebo will be stopped, and your doctor will give you a sedative (based on what the doctor thinks is best) for the rest of the time that you need it. You will be asked to complete the follow-up procedures that are mentioned below.

Before you receive the study drug or placebo, you will be given a medication (Robinul) by vein as well as oxygen with a face mask so that the study doctor can check to see that your heart does not beat too slowly. You will then receive dexmedetomidine or placebo by vein, as a continuous infusion, until the tube in your throat is in place and you are asleep under general anesthesia.

Your vital signs will be checked closely during the entire time you are receiving the study drug or placebo and once the tube is in your throat. About 15 minutes after the study drug or placebo infusion begins, and every 3 minutes after that, your study doctor will again check your level of sedation. If your study doctor thinks that you are not sedated and comfortable enough to begin the intubation procedure, you will receive a sedative (midazolam) by vein in small doses in which it will be given intermittently (started and stopped at different times) to ensure that you are sedated well enough before the tube is placed in your throat.

Once you are fully sedated, the study doctor will spray your throat and/or inside of the nose with lidocaine to help numb the airway, before inserting the tube. You will also breathe in the numbing medicine with oxygen using a mask over your nose and mouth. After allowing a few minutes to make sure your throat is numb, the doctor will begin inserting the tube. If your study doctor thinks you are no longer fully sedated during the insertion of the tube, you will again receive midazolam, as needed. Before stopping the infusion of the study drug or placebo, you will have about 1 ½ teaspoons of blood drawn for routine tests. The doctor will then stop the study drug or placebo infusion and give you the standard anesthetic drugs to put you to sleep for surgery.

After your study drug infusion or placebo (before your surgery), you will have another ECG performed and another check of your vital signs. Your doctor will answer any questions you may have about the intubation procedure.

Your routine follow-up evaluations will begin after the study drug or placebo infusion has been stopped and after your surgery. Around 24 hours later (in the hospital or by phone), you will be asked to complete a very brief survey to answer a few questions about what you remember from the intubation procedure. It should take about 2 minutes to complete.

After the 24-hour follow-up period, you may be contacted (depending on if you experienced any intolerable side effects) by your study doctor or study staff to obtain follow-up health information. During this phone call, you will be asked about any medications you may have taken or any health problems you may have experienced in the past 24 hours. Information about your side effects and health may be collected for up to 30 days (by phone) after the study drug or placebo infusion is stopped.

This is an investigational study. Dexmedetomidine is FDA approved and commercially available as a sedative for patients who are intubated. You are not being paid to participate in this study. You and/or your insurance provider will be responsible for the standard procedures while you are on this study. Hospira Inc. will provide dexmedetomidine to you at no charge. Up to 100 patients will take part in this multicenter study. Up to 20 will be enrolled at M. D. Anderson.

If you decide to participate in this study, you will be asked to complete all parts of the study from screening tests through the follow-up evaluations.

Minimum age: 18 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

1) Adult (>/= 18 years of age)

2) ASA score I - IV inclusive

3) Male or female. If female, subject is non-lactating and is either: (a.) 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. (b.) 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.

4) Requiring awake fiberoptic (oral/nasal) intubation because of anticipated difficult airway, as defined by at least one of the following criteria: History of difficult intubation, Anticipated difficult airway (Prominent protruding teeth, Small mouth opening, Narrow mandible, Micrognathia, Macroglossia, Short muscular neck, Very long neck, Limited neck extension, Congenital airway anomalies, Obesity, Known airway pathology, Known airway malignancy, Upper airway obstruction),

5) (Cont # 4): Trauma (Face, Upper airway, Cervical Spine), Anticipated difficult mask ventilation, Severe risk of aspiration, Respiratory failure, or Severe hemodynamic instability.

6) Subject (or subject’s legally authorized representative) must voluntarily sign and date the informed consent.

Exclusion Criteria:

1) Previous exposure to any experimental drug within 30 days prior to study drug administration

2) Central nervous system (CNS) disease with an anticipated increased intracranial pressure or cerebrospinal fluid (CSF) leak

3) Uncontrolled seizure disorder and/or known psychiatric illness that could confound a normal response to sedative treatment

4) Presence of acute alcohol intoxication

5) Current (within 14 days of study entry) treatment with an alpha subscript (2) - agonist or antagonist

6) Subject for whom benzodiazepines, DEX or other alpha subscript (2)- agonists are contraindicated

7) Subject received an IV or PO opioid within one hour or intramuscularly within four hours of the start of study drug administration

8) Subject has acute unstable angina, laboratory confirmed acute myocardial infarction within the past 6 weeks, heart rate <50 bpm, systolic blood pressure (SBP) <90 mmHg, or complete heart block unless they have a pacemaker

9) Subject has elevated SGPT (ALT) and/or SGOT (AST) values of > 2 times the upper limit of normal (ULN).

10) Subject has any other condition or factor which, in the Investigator’s opinion, might increase the risk to the subject.

U.T.M.D. Anderson Cancer Center, Houston, Texas 77030, United States

Starting date: December 2006
Last updated: June 4, 2007