VH: Hemodynamics During Induction of General Anesthesia After Prophylactic Ephedrine, Phenylephrine or Norepinephrine.

Sponsor

Helse Fonna (Other)

Overall Status

Recruiting

CT.gov ID

NCT03864094

Collaborator

(none)

Enrollment

Location

Arms

32.6

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this trial the investigators want to examine if there is any difference in hemodynamic stability when giving equipotent prophylactic injections of ephedrine 0,1 mg/kg, phenylephrine 1 microg/kg, norepinephrine 0,1 microg/kg or sodium chloride (NaCl) 9 mg/ml during induction of general anesthesia with propofol and remifentanil.

Condition or Disease	Intervention/Treatment	Phase
Hemodynamic Instability Anesthesia, General Anesthesia, Intravenous	Drug: Ephedrine Drug: Phenylephrine Drug: Norepinephrine Drug: Sodium chloride Drug: Propofol Drug: Remifentanil	Phase 4

Detailed Description

The LiDCOplus monitoring system (Lithium Dilutional Cardiac Output (LiDCO) Ltd., Cambridge, United Kingdom) is a minimally invasive monitor for measuring stroke volume (SV) using two different algorithms. The PulseCO (PulseCO ™, Cambridge, United Kingdom) is based on analyses of the the arterial pressure wave giving nominal values. The LiDCO uses lithium-dilution for calibration to give absolute values. In this trial, the investigators will use the PulseCO looking at relative changes in uncalibrated hemodynamic variables. Continual changes in systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial blood pressure (MAP), heart rate (HR), stroke volume (SV), cardiac output (CO) and systemic vascular resistance (SVR) will be measured.

Earlier studies have shown that propofol 2.5 mg/kg induction without opioid reduces CO (-15%), SV (-5 %), MAP (-33%) and SVR (-11%) and a slight reduction i HR. High-dose remifentanil anesthesia (2 microg/kg/min), in coronary patients reduced cardiac index (-25%), SV (-14%) and MAP (-39%) in a similar manner as propofol/remifentanil (propofol target 2 microg/ml and remifentanil 0.5 microg/kg/min), but systemic vascular resistance index decreased (-14%) in propofol/remifentanil combination.

Several procedures have been proposed to minimize the negative hemodynamic changes during induction. Administration of a crystalloid or a colloid did not prevent the decrease in MAP after induction of general anesthesia with propofol and fentanyl.

The hemodynamic effects in propofol-fentanyl anesthesia of preoperative ephedrine 0.07-0.15 mg/kg vs phenylephrine 1.5 microg/kg in valve surgery and concludes that ephedrine 0.07-0.1 mg/kg is safe and effective in counteracting hypotension. A dose of 0.15 mg/kg ephedrine is suggested for preventing hypotension during anesthesia induction with propofol 2.5 mg/kg and remifentanil 3 microg/kg.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

99 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, controlled, double-blind.Randomized, controlled, double-blind.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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 04Vaso). Patient, Care Provider and Investigator blinded for actual concentration of drug. Allocation break after data data wash and processing.

Primary Purpose:

Basic Science

Official Title:

"Haemodynamic Stability During Induction of General Anesthesia With Propofol and Remifentanil: A Randomized, Controlled, Double-blind Study Comparing Equipotent Prophylactic Doses of Ephedrine, Phenylephrine, Norepinephrine vs Placebo."

Actual Study Start Date :

Mar 15, 2022

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ephedrine Propofol Remifentanil Prophylactic Ephedrine	Drug: Ephedrine 0,1 mg/kg Other Names: Ephedrine Sulphate Injection Drug: Propofol 2 mg/kg Other Names: Propolipid Drug: Remifentanil 1,7 microg/kg Other Names: Ultiva
Active Comparator: Phenylephrine Propofol Remifentanil Prophylactic Phenylephrine	Drug: Phenylephrine 1 microg/kg Other Names: Phenylephrine Hydrocloride Injection Drug: Propofol 2 mg/kg Other Names: Propolipid Drug: Remifentanil 1,7 microg/kg Other Names: Ultiva
Active Comparator: Norepinephrine Propofol Remifentanil Prophylactic Norepinephrine	Drug: Norepinephrine 0,1 microg/kg Other Names: Noradrenalin Drug: Propofol 2 mg/kg Other Names: Propolipid Drug: Remifentanil 1,7 microg/kg Other Names: Ultiva
Sham Comparator: Sodium chloride Propofol Remifentanil NaCl Placebo	Drug: Sodium chloride 0,1 ml/kg Other Names: Sodium Chloride 0,9% injection Drug: Propofol 2 mg/kg Other Names: Propolipid Drug: Remifentanil 1,7 microg/kg Other Names: Ultiva

Outcome Measures

Primary Outcome Measures

Systolic Blood Pressure (SBP) [First 7,5 minutes from start of induction]
Change in SBP during induction as measured by the LiDCOplus monitoring system
Heart Rate (HR) [First 7,5 minutes from start of induction]
Change in HR during induction as measured by the LiDCOplus monitoring system

Secondary Outcome Measures

Stroke Volume (SV) [First 7,5 minutes from start of induction]
Change in SV during induction as measured by the LiDCOplus monitoring system
Cardiac Output (CO) [First 7,5 minutes from a start of induction]
Change in CO during induction as measured by the LiDCOplus monitoring system
Systemic Vascular Resistance (SVR) [First 7,5 minutes from start of induction]
Change in SVR during induction as measured by the LiDCOplus monitoring system