Dexmedetomidine vs. Remifentanil for Sedation During AFI

NCT00349245

Last updated date
Study Location
Memorial Hermann Hospital
Houston, Texas, 77030, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Endotracheal Intubation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- A signed informed consent must be obtained after the nature of the study has been fully explained.

- Patients undergoing any procedure requiring general anesthesia with an endotracheal tube.

- Patients that have been assessed by an attending anesthesiologist to have an airway requiring awake fiberoptic intubation.

- Adult patients > 18 yrs. old, ASA I - III.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Patients expected to have severe adverse side effects to Dexmedetomidine including:


1. Previous allergy to the drug.


2. 3rd degree AV Block


3. Hypovolemic hypotension


4. Systemic vasoconstriction


- Patients expected to have a severe adverse side effect to Remifentanil. This includes:


1. Previous allergy to the drug.


2. Patients suspected of being overly sensitive to narcotics.


- Patients with significant cardiovascular disease or ASA physical status IV and V

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Endotracheal IntubationDexmedetomidine vs. Remifentanil for Sedation During AFI
NCT00349245
  1. Houston, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Dexmedetomidine vs. Remifentanil for Sedation During AFI
Official Title  ICMJE A Randomized, Double-Blind Comparison Of Dexmedetomidine And Remifentanil For Sedation During Awake Fiberoptic Intubations
Brief Summary

The objective of this study is to determine the efficacy and safety of Dexmedetomidine, a selective alpha-2 adrenoceptor agonist, which has recently gained increased popularity for ICU and intraoperative sedation as a sedative during awake fiberoptic intubation, as compared to Remifentanil.

The hypothesis is that Dexmedetomidine will provide at least equal if not better conditions (sedation and analgesia) required for awake fiberoptic intubation (Ramsay Sedation Scale 3) with less respiratory and cardiovascular adverse effects, as well as less recall than Remifentanil.

Detailed Description

Awake nasal or oral fiberoptic intubation remains the method of choice for airway management in the expected difficult airway. This technique requires that a patient be comfortable, relaxed, cooperative and able to maintain their airway with spontaneous ventilation.

In order to achieve these conditions, the pharmacologic agent chosen for sedation should be short acting and highly titratable, provide the required amount of sedation and have little suppression of spontaneous ventilation. There have been numerous reports of the use of Remifentanil and Propofol used either alone or in combination to achieve this level of sedation.

Remifentanil has the following advantages which makes it a useful drug for this purpose:

  1. Ultra short acting with a constant half life
  2. Anti-tussive effects which help prevent coughing with tracheal manipulation
  3. Reversible with an antagonist naloxone
  4. Attenuates cardiovascular responses to laryngoscopy

Shortcomings of Remifentanil include undesirable side effects, such as hemodynamic instability and respiratory depression.

Dexmedetomidine is a centrally acting, selective alpha-2 agonist which has gained increasing popularity since 1999 as a drug for sedation in ICU settings. It has also been used for intraoperative sedation during surgery under regional anesthesia and for awake craniotomies, as well as for sedation of pediatric patients in different settings. Finally, there are also case reports of Dexmedetomidine being used for awake fiberoptic tracheal intubation.

Theoretically, the pharmacokinetic and pharmacodynamic properties of Dexmedetomidine make it an ideal drug as a single agent for sedation for awake fiberoptic intubation. Venn et al showed that in both healthy individuals and ICU patients, Dexmedetomidine shows a rapid onset and equally rapid distribution half life with quick recovery. This study also demonstrated stable hemodynamics during airway manipulation (extubation) with no adverse cardiovascular or respiratory events during the study.

Other studies have demonstrated that Dexmedetomidine attenuates cardiovascular responses to laryngoscopy and intubation and reduces the need for perioperative opioids. In small doses, it has been demonstrated to have good sedative, amnestic and analgesic effects, as well as anti-sialogogue effects.

Dexmedetomidine does, however, have some drawbacks. In higher bolus doses it can cause hemodynamic changes, such as excessive bradycardia and hypertension followed by hypotension. This drug has also been associated with decreased regional and global cerebral blood flow despite maintenance of MAP within the auto-regulating parameters. These deleterious effects are more prominent in patients with hypovolemia, systemic vasoconstriction, AV block and with rapid bolus infusion.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Condition  ICMJE Intubation, Endotracheal
Intervention  ICMJE
  • Drug: Remifentanil
  • Drug: Dexmedetomidine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 5, 2006)
30
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2007
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • A signed informed consent must be obtained after the nature of the study has been fully explained.
  • Patients undergoing any procedure requiring general anesthesia with an endotracheal tube.
  • Patients that have been assessed by an attending anesthesiologist to have an airway requiring awake fiberoptic intubation.
  • Adult patients > 18 yrs. old, ASA I - III.

Exclusion Criteria:

  • Patients expected to have severe adverse side effects to Dexmedetomidine including:

    1. Previous allergy to the drug.
    2. 3rd degree AV Block
    3. Hypovolemic hypotension
    4. Systemic vasoconstriction
  • Patients expected to have a severe adverse side effect to Remifentanil. This includes:

    1. Previous allergy to the drug.
    2. Patients suspected of being overly sensitive to narcotics.
  • Patients with significant cardiovascular disease or ASA physical status IV and V
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00349245
Other Study ID Numbers  ICMJE HSC-MS-06-0173
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carin A. Hagberg, The University of Texas Health Science Center, Houston
Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Collaborators  ICMJE Hospira, now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator:Carin A Hagberg, M.D.The University of Texas Medical School at Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP