CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 192 enrolled
Drug / intervention
Propofol Injectiondrug
Likely dose
Propofol Injection 2 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04194151
NCT04194151Phase 4Completed
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Impact of Propofol Dose Reduction in Relation to the Time Since Administration of Fentanyl During Anesthesia Induction

Hospital Central de la Defensa Gómez Ulla·interventional·Posted Dec 11, 2019·Updated Aug 12, 2020

In Brief

A Phase 4 clinical trial evaluating Propofol Injection for Propofol Adverse Reaction and Anesthesia. Completed, enrolled 192 participants across 1 site.

Detailed Summary

Objective: Determine if, by reducing the dose of propofol and increasing the time elapsed between fentanyl and propofol administration, hemodynamic response is improved. Methods: Patients were randomized into time groups (2 and 1 minute) and each subdivided into dose groups (1, 1.5 and 2 mg kg-1) obtaining six time-dose groups. After receiving 2 μg kg-1 of fentanyl, propofol was administered after the predetermined time. Time to hypnosis (BIS\<60) and hemodynamic parameters at pre-induction, pre-intubation and postintubation were registered.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPropofol Adverse Reaction, Anesthesia
CountriesSpain
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedDec 11, 2019
Enrollment StartNov 1, 2017
Primary CompletionOct 26, 2018
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 6.6 years ago

Interventions

Propofol Injectiondrug

1, 1.5 or 2 mg/kg of propofol according to the subgroup