Ignite Creation Date:
2024-05-06 @ 12:51 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03861377
Status:
COMPLETED
Last Update Posted:
2022-03-21
First Post:
2019-03-01
Brief Title:
Hemodynamics During Induction of General Anesthesia With Medium or Low Remifentanil Doses
Sponsor:
Helse Fonna
Organization:
Helse Fonna
Study Overview
Official Title:
Hemodynamic Stability During Induction of General Anesthesia With Propofol and Remifentanil A Randomized Controlled Double-blind Study Comparing Medium and Low Remifentanil Doses
Status:
COMPLETED
Status Verified Date:
2022-03
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:
RH
Brief Summary:
In this trial the investigators want to examine if there is any difference in hemodynamic stability during induction when comparing two low and a medium remifentanil dose and keeping propofol induction dose at about 20 mgkg
Detailed Description:
Typically one or more adjuvant medications is administered during induction of general anesthesia When anesthetic drugs are combined 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
Remifentanil is infused at 005-03 microgkgmin during induction of anesthesia Some use a loading dose of 05-10 microgkg before starting the continuous infusion The onset of action of remifentanil is within one to two minutes and it reaches rapidly a steady state effect site concentration after a bolus dose
Kazmaier 2000 showed that a high-dose remifentanil anesthesia 2 microgkgmin reduced cardiac index -25 stroke volume -14 and mean arterial blood pressure -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 Fairfield et al have earlier 1991 showed that propofol 25 mgkg induction without opioid reduces cardiac output -15 stroke volume -5 mean arterial pressure -33 and systemic vascular resistance -11 and a slight reduction i heart rate Guarracino 2003 suggests the reduction in cardiac index during induction with propofolremifentanil with a low propofol target 12 microgml may be due to decreased heart rate Zaballos 2009 have shown that remifentanil depresses sinus node and atrioventricular AV -nodal function in comparison with propofol alone in a closed chest porcine model Hayashi 2016 states that even in a low remifentanil effect site concentration 35 nanogml it may reduce heart rate significantly when combined with propofol bolus 30-50 mg
Remifentanil is infused at 005-03 microgkgmin during induction of anesthesia Some use a loading dose of 05-10 microgkg before starting the continuous infusion The onset of action of remifentanil is within one to two minutes and it reaches rapidly a steady state effect site concentration after a bolus dose
Kazmaier 2000 showed that a high-dose remifentanil anesthesia 2 microgkgmin reduced cardiac index -25 stroke volume -14 and mean arterial blood pressure -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 Fairfield et al have earlier 1991 showed that propofol 25 mgkg induction without opioid reduces cardiac output -15 stroke volume -5 mean arterial pressure -33 and systemic vascular resistance -11 and a slight reduction i heart rate Guarracino 2003 suggests the reduction in cardiac index during induction with propofolremifentanil with a low propofol target 12 microgml may be due to decreased heart rate Zaballos 2009 have shown that remifentanil depresses sinus node and atrioventricular AV -nodal function in comparison with propofol alone in a closed chest porcine model Hayashi 2016 states that even in a low remifentanil effect site concentration 35 nanogml it may reduce heart rate significantly when combined with propofol bolus 30-50 mg
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 |
|---|---|---|---|
| 2019-000961-19 | EUDRACT_NUMBER | None | None |