Dexmedetomidine vs. Remifentanil for Sedation During AFI

NCT00349245 | Completed Phase 4

• 1 other identifier: HSC-MS-06-0173
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation, Endotracheal

Keywords

Endotracheal; Awake fiberoptic intubation; Dexmedetomidine; Remifentanil

Outcome Measures

Primary Outcomes (2)

• Patient's reaction to procedure, as it occurs, ie. grimace, gag, verbalized pain.

  duration of intubation

• Memory recall

  post operative, immediately every 30 min for 3 hours and 24 hours

Secondary Outcomes (9)

• NIBP

  duration of intubation and first 15 minutes of surgery

• HR

  duration of intubation and first 15 minutes of surgery

• Cardiac rhythm

  duration of surgery

• Oxygen saturation

  duration of intubation and first 15 minutes of surgery

• End-tidal carbon dioxide

  duration of intubation and first 15 minutes of surgery

Interventions

Remifentanil DRUG

Dexmedetomidine DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients expected to have severe adverse side effects to Dexmedetomidine including:
• Previous allergy to the drug.
• rd degree AV Block
• Hypovolemic hypotension
• Systemic vasoconstriction
• Patients expected to have a severe adverse side effect to Remifentanil. This includes:
• Previous allergy to the drug.
• Patients suspected of being overly sensitive to narcotics.
• Patients with significant cardiovascular disease or ASA physical status IV and V

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Hospira, now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Remifentanil; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles

Study Officials

• Carin A Hagberg, M.D.

  The University of Texas Medical School at Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Joseph C. Gable, MD Endowed Chair

Study Record Dates

• First Submitted: July 5, 2006
• First Posted: July 6, 2006
• Study Start: June 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: March 23, 2016

Record last verified: 2016-03

Locations

US (1)