Dexmedetomidine vs. Remifentanil for Sedation During AFI

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Hospira, Inc.; Hospira, now a wholly owned subsidiary of Pfizer
• Treatments: Dexmedetomidine; Remifentanil

Criteria

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