Clinical trial NCT04194151: Impact of Propofol Reduction in Anesthesia Induction
Official title: Impact of Propofol Dose Reduction in Relation to the Time Since Administration of Fentanyl During Anesthesia Induction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Propofol Adverse Reaction
Anesthesia
Keywords: propofol synergy
fentanyl
anesthesia induction
Lead sponsor: Hospital Central de la Defensa Gómez Ulla
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 time groups, divided into 3 dose groups
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Systolic Blood Pressure Variation
timeFrame: Baseline before fentanyl administration, pre-intubation after propofol and bispectral index<60 and postintubation 15 seconds after endotracheal tube positioned
measure: Heart Rate Variation
timeFrame: Baseline before fentanyl administration, pre-intubation after propofol and bispectral index<60 and postintubation 15 seconds after endotracheal tube positioned
measure: Systolic Blood Pressure Variation in Elderly (>55y)
timeFrame: Baseline before fentanyl administration, pre-intubation after propofol and bispectral index<60 and postintubation 15 seconds after endotracheal tube positioned
Secondary outcomes:
measure: Time to Hypnosis
timeFrame: After administration of propofol, time is measured in seconds until BIS values are less than 60
measure: Number of Patients Who Needed Vasoactive Drug
timeFrame: 1 minute after intubation
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital central de la defensa Gomez Ulla
Study officials:
name: Paula A Vullo, MD
role: PRINCIPAL_INVESTIGATOR
References: