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NCT04194151

Impact of Propofol Reduction in Anesthesia Induction

Completed Phase 4 Results posted Last updated 12 August 2020
What this trial tests

Phase 4 trial testing Propofol Injection in Propofol Adverse Reaction in 192 participants. Completed in 26 October 2018.

Timeline
1 November 2017
Primary endpoint
26 October 2018
26 October 2018

Quick facts

Lead sponsorHospital Central de la Defensa Gómez Ulla
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposesupportive care
Enrollment192
Start date1 November 2017
Primary completion26 October 2018
Estimated completion26 October 2018
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Hospital Central de la Defensa Gómez Ulla

Who can join

18 and older, any sex, with Propofol Adverse Reaction or Anesthesia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Systolic Blood Pressure Variation Primary · Baseline before fentanyl administration, pre-intubation after propofol and bispectral index<60 and postintubation 15 seconds after endotracheal tube positioned

Non-invasive systolic blood pressure change (%) at baseline, pre-intubation and postintubation. Positive results mean percentage reduction in SBP between the studied moments. Negative results mean percentage increase in SBP between the studied moments.

SBP baseline/pre-intubation
GroupValue95% CI
2 Minute - 2 mg/kg Group26± 16
2 Minute - 1,5 mg/kg Group23± 12
2 Minute - 1 mg/kg Group18± 13
1 Minute - 2 mg/kg Group22± 11
1 Minute - 1,5 mg/kg Group18± 13
1 Minute - 1 mg/kg Group17± 13
SBP baseline/postintubation
GroupValue95% CI
2 Minute - 2 mg/kg Group11± 22
2 Minute - 1,5 mg/kg Group8± 15
2 Minute - 1 mg/kg Group9± 19
1 Minute - 2 mg/kg Group14± 18
1 Minute - 1,5 mg/kg Group16± 19
1 Minute - 1 mg/kg Group8± 16
SBP pre-intubation/postintubation
GroupValue95% CI
2 Minute - 2 mg/kg Group-22± 27
2 Minute - 1,5 mg/kg Group-21± 28
2 Minute - 1 mg/kg Group-12± 17
1 Minute - 2 mg/kg Group-12± 21
1 Minute - 1,5 mg/kg Group-3± 16
1 Minute - 1 mg/kg Group-12± 16
Heart Rate Variation Primary · Baseline before fentanyl administration, pre-intubation after propofol and bispectral index<60 and postintubation 15 seconds after endotracheal tube positioned

Heart rate change (%) registered at baseline, pre-intubation and postintubation. Positive results mean percentage reduction in HR between the studied moments. Negative results mean percentage increase in HR between the studied moments.

HR baseline/pre-intubation
GroupValue95% CI
2 Minute - 2 mg/kg Group6± 13
2 Minute - 1,5 mg/kg Group4± 8
2 Minute - 1 mg/kg Group4± 10
1 Minute - 2 mg/kg Group1± 11
1 Minute - 1,5 mg/kg Group4± 15
1 Minute - 1 mg/kg Group5± 14
HR baseline/postintubation
GroupValue95% CI
2 Minute - 2 mg/kg Group-10± 19
2 Minute - 1,5 mg/kg Group-8± 15
2 Minute - 1 mg/kg Group-9± 16
1 Minute - 2 mg/kg Group-4± 17
1 Minute - 1,5 mg/kg Group-5± 20
1 Minute - 1 mg/kg Group-10± 18
HR pre-intubation/postintubation
GroupValue95% CI
2 Minute - 2 mg/kg Group-17± 19
2 Minute - 1,5 mg/kg Group-12± 16
2 Minute - 1 mg/kg Group-15± 20
1 Minute - 2 mg/kg Group-5± 16
1 Minute - 1,5 mg/kg Group-10± 19
1 Minute - 1 mg/kg Group-17± 19
Systolic Blood Pressure Variation in Elderly (>55y) Primary · Baseline before fentanyl administration, pre-intubation after propofol and bispectral index<60 and postintubation 15 seconds after endotracheal tube positioned

Non-invasive SBP change (%) in patients \> 55 years at baseline, pre-intubation and postintubation. Positive results mean percentage reduction in SBP between the studied moments. Negative results mean percentage increase in SBP between the studied moments.

SBP baseline/pre-intubation
GroupValue95% CI
2 Minute - 2 mg/kg Group36± 12
2 Minute - 1,5 mg/kg Group26± 12
2 Minute - 1 mg/kg Group21± 13
1 Minute - 2 mg/kg Group29± 6
1 Minute - 1,5 mg/kg Group21± 13
1 Minute - 1 mg/kg Group22± 13
SBP baseline/postintubation
GroupValue95% CI
2 Minute - 2 mg/kg Group19± 22
2 Minute - 1,5 mg/kg Group10± 14
2 Minute - 1 mg/kg Group13± 19
1 Minute - 2 mg/kg Group22± 15
1 Minute - 1,5 mg/kg Group22± 17
1 Minute - 1 mg/kg Group12± 13
SBP pre-intubation/postintubation
GroupValue95% CI
2 Minute - 2 mg/kg Group-27± 32
2 Minute - 1,5 mg/kg Group-23± 30
2 Minute - 1 mg/kg Group-10± 16
1 Minute - 2 mg/kg Group-10± 23
1 Minute - 1,5 mg/kg Group2± 13
1 Minute - 1 mg/kg Group-15± 19
Time to Hypnosis Secondary · After administration of propofol, time is measured in seconds until BIS values are less than 60

Bispectral index (BIS)\<60 meaning "general anesthesia", BIS\>60 meaning mild/moderate sedation. We measure the time until patient reachs hypnosis

GroupValue95% CI
2 Minute - 2 mg/kg Group54± 29
2 Minute - 1,5 mg/kg Group49± 27
2 Minute - 1 mg/kg Group62± 34
1 Minute - 2 mg/kg Group41± 20
1 Minute - 1,5 mg/kg Group47± 15
1 Minute - 1 mg/kg Group67± 42
Number of Patients Who Needed Vasoactive Drug Secondary · 1 minute after intubation

Patients who suffered SPB reduction \> 30% or SPB \< 90mmHg, receive vasoactive drugs

GroupValue95% CI
2 Minute - 2 mg/kg Group4
2 Minute - 1,5 mg/kg Group1
2 Minute - 1 mg/kg Group0
1 Minute - 2 mg/kg Group2
1 Minute - 1,5 mg/kg Group3
1 Minute - 1 mg/kg Group0

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline until 60 seconds after endotracheal tube positioned. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

2 Minute - 2 mg/kg Group
Serious: 0/31 (0%)
Deaths: 0/31
2 Minute - 1,5 mg/kg Group
Serious: 0/30 (0%)
Deaths: 0/30
2 Minute - 1 mg/kg Group
Serious: 0/31 (0%)
Deaths: 0/31
1 Minute - 2 mg/kg Group
Serious: 0/31 (0%)
Deaths: 0/31
1 Minute - 1,5 mg/kg Group
Serious: 0/32 (0%)
Deaths: 0/32
1 Minute - 1 mg/kg Group
Serious: 0/31 (0%)
Deaths: 0/31
Other adverse events (1 terms — click to expand)

ReactionSystem2 Minute - 2 mg/kg Group2 Minute - 1,5 mg/kg Group2 Minute - 1 mg/kg Group1 Minute - 2 mg/kg Group1 Minute - 1,5 mg/kg Group1 Minute - 1 mg/kg Group
Vasoactive drug needCardiac disorders——————

Data from ClinicalTrials.gov NCT04194151 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Hemodynamic impact of increasing time between fentanyl and propofol administration during anesthesia induction: a randomised, clinical trial.
    Vullo PA, Real Navacerrada MÍI, Navarro Suay R. · · 2024 · cited 6× · PMID 34324933 · DOI 10.1016/j.bjane.2021.07.009

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