Controlled Sedation for Cataract Surgery

Failed Conscious Sedation During Procedure Clinical Trial

Official title:

Dexmedetomidine vs. Remifentanil for Patient and Surgeon Satisfaction in Cataract Surgery Under Controlled Sedation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03401606
• Other study ID #: 516-3847-33
• Status: Terminated
• Phase: Phase 4
• First received: December 14, 2015
• Last updated: January 16, 2018
• Start date: November 1, 2014
• Est. completion date: January 30, 2016

Study information

• Verified date: January 2018
• Source: Fundación Universitaria de Ciencias de la Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the surgeon and patient´s satisfaction who undergoes cataract surgery using either dexmedetomidine or remifentanil as sedation

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 information / eligibility

• Status: Terminated
• Enrollment: 98
• Est. completion date: January 30, 2016
• Est. primary completion date: October 30, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• subject has cataract,

• subject older than 18 years,

• local anesthesia and sedation.

Exclusion Criteria:

• general anesthesia,

• history of consumption of sedatives.

Related Conditions & MeSH terms

• Cataract
• Failed Conscious Sedation During Procedure

Intervention

Drug:
• remifentanil
remifentanil, 0.25 ng/mL, given intravenous, infusion, until surgery finished
• Dexmedetomidine
dexmedetomidine, 0.125 mcg/kg/hour, given intravenous, infusion, until surgery finished

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Universitaria de Ciencias de la Salud

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hypotension	Systolic blood pressure below 90 mmHg	Intraoperative
Other	Respiratory depression	Decreased respiratory rate below 10 rpm and desaturation, situation that required intubation	Intraoperative
Other	Oxygen desaturation	Hemoglobin oxygen saturation below 90%	Intraoperative
Other	Internation	Inpatient treatment	Intraoperative
Primary	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.	Intraoperative
Secondary	Heart rate	Beats per minute (bpm)	Intraoperative
Secondary	Mean arterial pressure	Millimeters of mercury (mmHg)	Intraoperative
Secondary	Hemoglobin oxygen saturation	Oxygen saturation (%)	Intraoperative
Secondary	Surgery duration	Minutes	Intraoperative