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OpenTrials
Completed

NCT Number: NCT00786370

Dexmedetomidine vs. Propofol for Cataract Surgery

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)

Treatment and study plan

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.

Propofol

Drug

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

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.

Primary outcomes

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

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

The Cooper Health System

Other

Registry information

Official study title

Dexmedetomidine vs. Propofol for Monitored Anesthesia Care During Cataract

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 6, 2008
Registry last updated
Feb 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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