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Completed

NCT Number: NCT04194151

Impact of Propofol Reduction in Anesthesia Induction

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital central de la defensa Gomez Ulla

Madrid, 28047, Spain

About this study

A minimum of 162 patients were required, considering an expected Mean Difference of 5 with expected Standard Deviation of 22, confidence level of 95% and power of 80%. Estimating a possible loss of 15%, it was raised to 192. Consecutive identification numbers were assigned and the sample was randomized in six groups of 32 patients according to time and dose of propofol.

Pre-oxygenation was performed until the expired oxygen fraction exceeded 80% and 2 µg/kg of intravenous fentanyl were administered. Depending on the study group, 1 or 2 minutes were allowed to pass and 1, 1.5 or 2 mg/kg of propofol were supplied (prior administration of intravenous lidocaine 0.5 mg/kg). The time in which the BIS dropped below 60 was recorded. If it did not reach that level after two minutes or when it exceeded it but then rose above 60 again, an extra dose of propofol of 0.5 mg/kg was administered. Muscle relaxation was performed with rocuronium 0.6 mg/kg. The patient was manually ventilated until endotracheal intubation was performed by the same experienced anaesthesiologist and connected to mechanical ventilation.

Data were collected manually. Statistical analysis was performed using SPSS ver. 22. Inferential statistics were performed using t-test for quantitative variables, chi-square for qualitative and ANOVA for qualitative and quantitative comparisons. Non-parametric statistical tests were used when necessary. Confidence intervals were estimated at a level of 95% and a P value of <.05 was considered statistically significant.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults who required general anesthesia
  • General anesthesia with endotracheal intubation (no supraglottic devices)
  • Signed informed consent
  • Non-cardiac surgery
  • Same anesthesiologist

Exclusion criteria

  • Hemodynamic instability (systolic BP < 90 mmHg with clinical signs of low cardiac output: impaired consciousness, diuresis <0.5 ml/kg/h, central venous saturation <60% with normal arterial saturation or lactate >3 mmol/l)
  • Increased risk of bronchoaspiration (absence of fasting, stomach retention, intestinal obstruction, pregnancy, etc.)
  • Suspected difficult airway
  • Known allergy to anesthetic drugs

Treatment and study plan

Propofol Injection

Drug

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

Primary outcomes

  1. Systolic Blood Pressure Variation

    Time frame: 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.

  2. Heart Rate Variation

    Time frame: 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.

  3. Systolic Blood Pressure Variation in Elderly (>55y)

    Time frame: 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.

Secondary outcomes

  1. Time to Hypnosis

    Time frame: 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

  2. Number of Patients Who Needed Vasoactive Drug

    Time frame: 1 minute after intubation

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

Sponsors and collaborators

Lead sponsor

Hospital Central de la Defensa Gómez Ulla

Other

Registry information

Official study title

Impact of Propofol Dose Reduction in Relation to the Time Since Administration of Fentanyl During Anesthesia Induction

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 11, 2019
Registry last updated
Aug 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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