Controlled Sedation for Cataract Surgery
Phase 4
Terminated
- Conditions
- Failed Conscious Sedation During Procedure
- Interventions
- Registration Number
- NCT03401606
- Lead Sponsor
- Fundación Universitaria de Ciencias de la Salud
- Brief Summary
This study evaluates the surgeon and patient´s satisfaction who undergoes cataract surgery using either dexmedetomidine or remifentanil as sedation
- Detailed Description
This is a double blind, randomized study which evaluates surgeon and patient´s satisfaction whom undergoes cataract surgery. The surgery was done under local anesthesia and sedation.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 98
Inclusion Criteria
- subject has cataract,
- subject older than 18 years,
- local anesthesia and sedation.
Exclusion Criteria
- general anesthesia,
- history of consumption of sedatives.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Remifentanil remifentanil remifentanil and dexmedetomidine, 0.25 ng/mL, given intravenous, infusion, until surgery finished. Dexmedetomidine Dexmedetomidine dexmedetomidine and remifentanil, 0.125 mcg/kg/hour, given intravenous, infusion, until surgery finished
- Primary Outcome Measures
Name Time Method Surgeon and patient satisfaction Intraoperative It was evaluated with an absolute numerical subjective scale from 1 to 7, where a score of 1 means total dissatisfaction, and 7 complete satisfaction. Scores were evaluated 30 minutes after surgery begun and at the end of the procedure. Results are presented in median and interquartile ranges.
- Secondary Outcome Measures
Name Time Method Heart rate Intraoperative Beats per minute (bpm)
Mean arterial pressure Intraoperative Millimeters of mercury (mmHg)
Hemoglobin oxygen saturation Intraoperative Oxygen saturation (%)
Surgery duration Intraoperative Minutes