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

Anesthesia, General Clinical Trial

— PH  

Official title:

Haemodynamic Stability During Induction of General Anesthesia With Propofol and Remifentanil: A Randomized, Controlled, Double-blind Study Comparing Low vs High Propofol Doses.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03861364
• Other study ID #: 2019/375
• Secondary ID: 2019-000958-56
• Status: Completed
• Phase: Phase 4
• Start date: September 3, 2019
• Est. completion date: May 31, 2020

Study information

• Verified date: June 2020
• Source: Helse Fonna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Typically, one or more adjuvant medications are administered to supplement induction of general anesthesia. When combining anesthetic drugs, the hypnotic effects are often synergistic. Propofol is associated with hypotension and bradycardia and used together with remifentanil or sedative agents it may give synergistic or additive sedative and hemodynamic effects.

Claeys (1988) and Fairfield (1991) examined the cardiovascular effects of propofol 2-2.5 mg/kg induction dose and found significant reductions i SBP and SVR and small changes in CO, SV and HR. De Wit (2016) examined hemodynamic changes in different steady state propofol serum concentrations, and found a dose dependent SBP reduction, reduction in resistance of arterial and systemic circulation and a reduction in mean systemic filling pressures (MSFP) indicative of a reduction in "stressed volumes". The effective dose (ED) 95% for loss of consciousness for propofol was determined to 1.75 mg/kg when used alone, and 1.38 mg/kg when used together with remifentanil 0.25 microg/kg/min (total induction dose 1.75 microg/kg remifentanil) in a study by Koh et al. We want to examine the hemodynamic effects of giving a low (1.4 mg/kg) vs a high (2.4 mg/kg) propofol dose combined with a moderate remifentanil dose (about 1.5 microg/kg).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: May 31, 2020
• Est. primary completion date: May 19, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy women

• Age 18-50 years

• Gynecological procedures

• General anesthesia

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anesthesia, General
• Anesthesia, Intravenous
• Hemodynamics Instability

Intervention

Drug:
• Propofol
2,4 mg/kg
• Propofol
1,4 mg/kg

Locations

Country	Name	City	State
Norway	Kirurgisk Klinikk-Anestesi	Haugesund	Rogaland

Sponsors (1)

Lead Sponsor	Collaborator
Helse Fonna

Country where clinical trial is conducted

Norway, 

References & Publications (4)

Claeys MA, Gepts E, Camu F. Haemodynamic changes during anaesthesia induced and maintained with propofol. Br J Anaesth. 1988 Jan;60(1):3-9. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic blood pressure (SBP)	Relative change of SBP (mmHg)	The first 7.5 minutes during induction of general anesthesia
Primary	Heart rate (HR)	Relative change of HR (beats)	The first 7.5 minutes during induction of general anesthesia
Secondary	Stroke Volume (SV)	Relative change of SV (ml/beat)	The first 7.5 minutes during induction of general anesthesia
Secondary	Cardiac Output (CO)	Relative change of CO (litre/min)	The first 7.5 minutes during induction of general anesthesia
Secondary	Systemic Vascular Resistance (SVR)	Relative change of SVR (dynes-sec/cm5/m2)	The first 7.5 minutes during induction of general anesthesia