Ignite Creation Date:
2024-05-06 @ 12:51 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03864094
Status:
COMPLETED
Last Update Posted:
2023-09-28
First Post:
2019-03-01
Brief Title:
Hemodynamics During Induction of General Anesthesia After Prophylactic Ephedrine Phenylephrine or Norepinephrine
Sponsor:
Helse Fonna
Organization:
Helse Fonna
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VH
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 01 mgkg phenylephrine 1 microgkg norepinephrine 01 microgkg or sodium chloride NaCl 9 mgml during induction of general anesthesia with propofol and remifentanil
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 25 mgkg induction without opioid reduces CO -15 SV -5 MAP -33 and SVR -11 and a slight reduction i HR High-dose remifentanil anesthesia 2 microgkgmin in coronary patients reduced cardiac index -25 SV -14 and MAP -39 in a similar manner as propofolremifentanil propofol target 2 microgml and remifentanil 05 microgkgmin but systemic vascular resistance index decreased -14 in propofolremifentanil 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 007-015 mgkg vs phenylephrine 15 microgkg in valve surgery and concludes that ephedrine 007-01 mgkg is safe and effective in counteracting hypotension A dose of 015 mgkg ephedrine is suggested for preventing hypotension during anesthesia induction with propofol 25 mgkg and remifentanil 3 microgkg
Earlier studies have shown that propofol 25 mgkg induction without opioid reduces CO -15 SV -5 MAP -33 and SVR -11 and a slight reduction i HR High-dose remifentanil anesthesia 2 microgkgmin in coronary patients reduced cardiac index -25 SV -14 and MAP -39 in a similar manner as propofolremifentanil propofol target 2 microgml and remifentanil 05 microgkgmin but systemic vascular resistance index decreased -14 in propofolremifentanil 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 007-015 mgkg vs phenylephrine 15 microgkg in valve surgery and concludes that ephedrine 007-01 mgkg is safe and effective in counteracting hypotension A dose of 015 mgkg ephedrine is suggested for preventing hypotension during anesthesia induction with propofol 25 mgkg and remifentanil 3 microgkg
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-000965-19 | EUDRACT_NUMBER | None | None |