Ignite Creation Date:
2024-05-06 @ 12:51 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03861364
Status:
COMPLETED
Last Update Posted:
2020-06-17
First Post:
2019-03-01
Brief Title:
Hemodynamics During Induction of General Anesthesia With High and Low Propofol Dose
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 Low vs High Propofol Doses
Status:
COMPLETED
Status Verified Date:
2020-06
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:
PH
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
Detailed 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 2-25 mgkg 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 175 mgkg when used alone and 138 mgkg when used together with remifentanil 025 microgkgmin total induction dose 175 microgkg remifentanil in a study by Koh et al We want to examine the hemodynamic effects of giving a low 14 mgkg vs a high 24 mgkg propofol dose combined with a moderate remifentanil dose about 15 microgkg
Claeys 1988 and Fairfield 1991 examined the cardiovascular effects of propofol 2-25 mgkg 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 175 mgkg when used alone and 138 mgkg when used together with remifentanil 025 microgkgmin total induction dose 175 microgkg remifentanil in a study by Koh et al We want to examine the hemodynamic effects of giving a low 14 mgkg vs a high 24 mgkg propofol dose combined with a moderate remifentanil dose about 15 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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-000958-56 | EUDRACT_NUMBER | None | None |