Analyzing the Relationship Between Speed Propofol is Given and Low Blood Pressure

University of Toledo

Status and phase: Completed; Phase 3

Conditions: Hypotension on Induction

Treatments: Other: Propofol slow administration

Study type: Interventional

Funder types: Other

Identifiers

NCT05415436

Propofol study

Details and patient eligibility

About

The objective of this study is to evaluate the hemodynamic changes related to Propofol administration rate. We hypothesize that slow administration of IV propofol will have less hemodynamic disturbances and will require less amount of vasoactive medication for BP correction when compared to standard FDA approved administration rate.

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• any patient from 18 till 80 years of age
• patient undergoing non-cardiac elective surgery
• duration of the surgery longer than one hour
• native/fluent English speaker
• patients whose staff anesthesiologist planned to use Propofol as a primary anesthetic for induction

Exclusion criteria

• any patient admitted for non-elective surgery
• any patient undergoing cardiac surgery
• any patient under 18 years of age
• any patient older than 80 years of age
• any patient with history of severe heart disease (CHF with significant limitations of activity due to sever symptoms, prior heart surgery, atrial fibrillation, etc.)
• any patient with pre-operative hemodynamic instability (e.g. sepsis, chronic kidney disease, liver cirrhosis) who requires constant or intermittent administration of vasoactive or inotropic medication to support vital signs (BP)
• any patient on vasoactive or inotrop medications in early pre-operative period (within 24 hours prior to the surgery)
• any patient who does not speak English or not fluently
• any patient with cognitive impairment or mentally incapacitation
• any pregnant or breastfeeding females
• any patient whose staff anesthesiologist planned to use a primary anesthetic other than Propofol

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Group A- propofol given at FDA approved administration speed

No Intervention group

Group B- propofol given over 120 seconds

Experimental group

Treatment:

Other: Propofol slow administration