Hemodynamics During Induction of General Anesthesia With High and Low Propofol Dose.

NCT03861364 | Completed Phase 4

• 2 other identifiers: 2019/3752019-000958-56
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The study objective is to examine if a high propofol dose is non-inferior to a low dose in respect to hemodynamic stability in healthy patients during induction of general anesthesia with propofol and remifentanil.

Conditions

Hemodynamics Instability; Anesthesia, General; Anesthesia, Intravenous

Keywords

Cardiac Output (CO); Systolic Blood Pressure (SBP); Systemic Vascular Resistance (SVR); Heart Rate (HR); Stroke Volume (SV); Lithium Dilutional Cardiac Output (LiDCO); Minimal Invasive Hemodynamic Monitor; Propofol; Propolipid

Outcome Measures

Primary Outcomes (2)

• Systolic blood pressure (SBP)

  Relative change of SBP (mmHg)

  The first 7.5 minutes during induction of general anesthesia

• Heart rate (HR)

  Relative change of HR (beats)

  The first 7.5 minutes during induction of general anesthesia

Secondary Outcomes (3)

• Stroke Volume (SV)

  The first 7.5 minutes during induction of general anesthesia

• Cardiac Output (CO)

  The first 7.5 minutes during induction of general anesthesia

• Systemic Vascular Resistance (SVR)

  The first 7.5 minutes during induction of general anesthesia

Study Arms (2)

High Propofol

ACTIVE COMPARATOR

High Propofol induction dose

Drug: Propofol

Low Propofol

ACTIVE COMPARATOR

Low Propofol induction dose

Drug: Propofol

Interventions

Propofol DRUG

2,4 mg/kg

Also known as: Propolipid

High Propofol

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy women
• Age 18-50 years
• Gynecological procedures
• General anesthesia

You may not qualify if:

• Pre-existing hypertension
• Diabetes for several years
• Ischemic heart disease
• Cerebrovascular disease
• Heart valve disease
• Verified cardiac arrhythmia
• Anaemia
• Kidney or hepatic disease
• Hypersensitivity for soya, eggs or peanuts
• Pregnancy
• Poor health state
• Illicit substance use
• BMI \<20 or \>35 kg/m2
• SBP \>150 mmHg
• HR \>100 beats/min

Sponsors & Collaborators

• Helse Fonna: lead

Study Sites (1)

Kirurgisk Klinikk-Anestesi

Haugesund, Rogaland, 5504, Norway

Location

Related Publications (5)

• Koh JC, Park J, Kim NY, You AH, Ko SH, Han DW. Effects of remifentanil with or without midazolam pretreatment on the 95% effective dose of propofol for loss of consciousness during induction: A randomized, clinical trial. Medicine (Baltimore). 2017 Dec;96(49):e9164. doi: 10.1097/MD.0000000000009164.

  PMID: 29245361 BACKGROUND

• Claeys MA, Gepts E, Camu F. Haemodynamic changes during anaesthesia induced and maintained with propofol. Br J Anaesth. 1988 Jan;60(1):3-9. doi: 10.1093/bja/60.1.3.

  PMID: 3257393 BACKGROUND

• Fairfield JE, Dritsas A, Beale RJ. Haemodynamic effects of propofol: induction with 2.5 mg kg-1. Br J Anaesth. 1991 Nov;67(5):618-20. doi: 10.1093/bja/67.5.618.

  PMID: 1751277 BACKGROUND

• de Wit F, van Vliet AL, de Wilde RB, Jansen JR, Vuyk J, Aarts LP, de Jonge E, Veelo DP, Geerts BF. The effect of propofol on haemodynamics: cardiac output, venous return, mean systemic filling pressure, and vascular resistances. Br J Anaesth. 2016 Jun;116(6):784-9. doi: 10.1093/bja/aew126.

  PMID: 27199311 BACKGROUND

• Sjoen GH, Falk RS, Hauge TH, Tonnessen TI, Langesaeter E. Hemodynamic effects of a low versus a high dose of propofol during induction of anesthesia. A randomized trial. Acta Anaesthesiol Scand. 2023 Oct;67(9):1178-1186. doi: 10.1111/aas.14293. Epub 2023 Jun 8.

  PMID: 37291731 DERIVED

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Gunnar H Sjøen, MD

  Helse Fonna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization made by a person not involved in trial in other ways. Allocation masked in sealed envelopes, stored in a locked cash box only opened by two drug preparing nurses not involved in patient care. Syringe labelled with patient identification (ID) (eg 03Prop). Patient, Care Provider and Investigator blinded for actual concentration of drug. Allocation break after data data wash and processing.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Overlege, anestesi

Model Details: Randomized, controlled, double blind.

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: March 4, 2019
• Study Start: September 3, 2019
• Primary Completion: May 19, 2020
• Study Completion: May 31, 2020
• Last Updated: June 17, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The data will be stored for 15 years after end of study, and may be shared during this time frame.
• Access Criteria: The data may be shared by contacting the Principal Investigator.

Locations

NO (1)