Dexmedetomidine vs. Propofol for Cataract Surgery

NCT00786370 | Completed Phase 4

• 1 other identifier: RP 08-045
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The use of dexmedetomidine in cataract surgery is still limited and to date only one study has examined anesthetic technique in this patient population. This pilot study will therefore compare the use of dexmedetomidine and propofol in subjects undergoing cataract surgery. The primary endpoint will be based on simple cardiorespiratory measures often associated with complications from sedation as well as assessment of the achieved sedation by the attending anesthesiologist and surgeon.

Conditions

Cataract

Keywords

propofol; dexmedetomidine; cataract; respiratory; blood pressure; Cataract surgery

Outcome Measures

Primary Outcomes (1)

• To compare select cardiorespiratory effects of dexmedetomidine sedation to those of propofol sedation in patients undergoing cataract surgery.

  1 day

Study Arms (2)

Propofol

ACTIVE COMPARATOR

Drug: Propofol

Dexmedetomidine

EXPERIMENTAL

Drug: dexmedetomidine; Drug: Dexemedetomidine

Interventions

dexmedetomidine DRUG

Propofol or dexmedetomidine infusion will be started according to the randomized treatment allocation. The propofol group will receive a bolus of 2mg midazolam and 100mcg fentanyl and then continuous propofol infusion at 50-100mcg/kg/min until a Ramsay score of 3 or Bis score of 60-80 is achieved. The dexmedetomidine group will receive a bolus of dexmedetomidine 1mcg/kg for 10 minutes and then a continuous infusion of dexmedetomidine 0.2-0.7mcg/kg/hr until a Ramsay score of 3 or a Bis score of 60-80 are achieved.

Dexmedetomidine

Propofol DRUG

continuous propofol infusion at 50-100mcg/kg/min until a Ramsay score of 3 or Bis score of 60-80 is achieved

Propofol

Dexemedetomidine DRUG

continuous infusion of dexmedetomidine 0.2-0.7mcg/kg/hr until a Ramsay score of 3 or a Bis score of 60-80 are achieved.

Dexmedetomidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Normal renal function
• No chronic use of narcotics
• ASA PS1-3
• Males or females age 18 or older

You may not qualify if:

• Liver disease (Child Pugh classification 1-3)
• History of chronic use of sedatives, narcotics, alcohol or illicit drugs or allergy to any the study medications
• History of 1st and 2nd degree heart block (not paced)
• Any patient with EF \< 30%
• Patients with active seizure history
• Pregnant patients (women of child bearing potential will have a preoperative pregnancy test as is standard of practice)

Sponsors & Collaborators

• The Cooper Health System: lead

Study Sites (1)

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

Dexmedetomidine; Propofol

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Jeffrey Littman, MD

  The Cooper Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 5, 2008
• First Posted: November 6, 2008
• Study Start: April 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: February 10, 2012

Record last verified: 2008-11

Locations

US (1)