NCT03401606

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2014

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2016

Completed
2 years until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

12 months

First QC Date

December 14, 2015

Last Update Submit

January 16, 2018

Conditions

Failed Conscious Sedation During Procedure

Keywords

sedationdexmedetomidineremifentanilcataract surgerysurgeon satisfactionpatient satisfaction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Heart rate

    Intraoperative

  • Mean arterial pressure

    Intraoperative

  • Hemoglobin oxygen saturation

    Intraoperative

  • Surgery duration

    Intraoperative

Other Outcomes (4)

  • Hypotension

    Intraoperative

  • Respiratory depression

    Intraoperative

  • Oxygen desaturation

    Intraoperative

  • +1 more other outcomes

Study Arms (2)

Remifentanil

ACTIVE COMPARATOR

remifentanil and dexmedetomidine, 0.25 ng/mL, given intravenous, infusion, until surgery finished.

Drug: remifentanil

Dexmedetomidine

ACTIVE COMPARATOR

dexmedetomidine and remifentanil, 0.125 mcg/kg/hour, given intravenous, infusion, until surgery finished

Drug: Dexmedetomidine

Interventions

remifentanilDRUG

remifentanil, 0.25 ng/mL, given intravenous, infusion, until surgery finished

Remifentanil
DexmedetomidineDRUG

dexmedetomidine, 0.125 mcg/kg/hour, given intravenous, infusion, until surgery finished

Dexmedetomidine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subject has cataract,
  • subject older than 18 years,
  • local anesthesia and sedation.

You may not qualify if:

  • general anesthesia,
  • history of consumption of sedatives.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Patient Satisfaction

Interventions

RemifentanilDexmedetomidine

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

PropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsImidazolesAzoles

Study Officials

  • Luis Muñoz, Md

    Fundacion universitaria de ciencias de la salud

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2015

First Posted

January 17, 2018

Study Start

November 1, 2014

Primary Completion

October 30, 2015

Study Completion

January 30, 2016

Last Updated

January 17, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share