A Phase 4 interventional study of remifentanil and Dexmedetomidine in Failed Conscious Sedation During Procedure, sponsored by Fundación Universitaria de Ciencias de la Salud. Terminated. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-17.
Sponsored by Fundación Universitaria de Ciencias de la Salud · Phase 4, Interventional, and Treatment
This study evaluates the surgeon and patient´s satisfaction who undergoes cataract surgery using either dexmedetomidine or remifentanil as sedation
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.
877 studies on the registry are indexed under Patient Satisfaction; 202 are open to participants now.
This study's enrollment of 98 is close to the median of 96 across 624 interventional studies indexed under Patient Satisfaction.
Browse Patient Satisfaction studies →Fundación Universitaria de Ciencias de la Salud is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
remifentanil and dexmedetomidine, 0.25 ng/mL, given intravenous, infusion, until surgery finished.
Drug: remifentanil
dexmedetomidine and remifentanil, 0.125 mcg/kg/hour, given intravenous, infusion, until surgery finished
Drug: Dexmedetomidine
remifentanil, 0.25 ng/mL, given intravenous, infusion, until surgery finished
dexmedetomidine, 0.125 mcg/kg/hour, given intravenous, infusion, until surgery finished
Surgeon and patient satisfaction
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.
Time frame: Intraoperative
Heart rate
Beats per minute (bpm)
Time frame: Intraoperative
Mean arterial pressure
Millimeters of mercury (mmHg)
Time frame: Intraoperative
Hemoglobin oxygen saturation
Oxygen saturation (%)
Time frame: Intraoperative
Surgery duration
Minutes
Time frame: Intraoperative
Hypotension
Systolic blood pressure below 90 mmHg
Time frame: Intraoperative
Respiratory depression
Decreased respiratory rate below 10 rpm and desaturation, situation that required intubation
Time frame: Intraoperative
Oxygen desaturation
Hemoglobin oxygen saturation below 90%
Time frame: Intraoperative
Internation
Inpatient treatment
Time frame: Intraoperative
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2014 to primary completion in Oct 2015, 11 months.
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This study is terminated, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Remifentanil · Dexmedetomidine
Fundación Universitaria de Ciencias de la Salud