Phase 4
N=192
Impact of Propofol Reduction in Anesthesia Induction
Propofol Adverse Reaction · Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT04194151 ↗Enrolled (actual)
192
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Systolic Blood Pressure Variation — 26; 23; 18; 22 percentage of variation
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Propofol Injection (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hospital Central de la Defensa Gómez Ulla
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Systolic Blood Pressure Variation |
26; 23; 18; 22; 18; 17 | — |
| PRIMARY Heart Rate Variation |
6; 4; 4; 1; 4; 5 | — |
| PRIMARY Systolic Blood Pressure Variation in Elderly (>55y) |
36; 26; 21; 29; 21; 22 | — |
| SECONDARY Time to Hypnosis |
54; 49; 62; 41; 47; 67 | — |
| SECONDARY Number of Patients Who Needed Vasoactive Drug |
4; 1; 0; 2; 3; 0 | — |
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.
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 3 mmol/l)
- Increased risk of bronchoaspiration (absence of fasting, stomach retention, intestinal obstruction, pregnancy, etc.)
- Suspected difficult airway
- Known allergy to anesthetic drugs
Data sourced from ClinicalTrials.gov (NCT04194151). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.