Determine whether phenylephrine or norepinephrine has superior haemodynamical effects in ophtalmic surgery
ID
Source
Brief title
Condition
- Other condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
Synonym
Health condition
Geen specifieke aandoening, slechts ter coupering van de hypotensie veroorzakende, routine gebruikte, anesthetica
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Arterial blood pressure, cardiac index, systemic vascular resistance,
peripheral tissue oxygenation, cerebral oxygen saturation, buccal
microcirculation.
Secondary outcome
NA
Background summary
In ophtalmic surgery the specific anaesthesiological challenges necessitate the
administration of a combination of relatively high doses of hypnotics and
analgetics. In order to preserve adequate organ perfusion, there is often a
need to administer pharmacological agents for haemodynamic support. Depending
on the experience of the anaesthetist a continuous infusion of phenylephrine or
norepinephrine is used. It is currently not known which of these agents has the
most favorable haemodynamical profile.
Haemodynamic parameters (continuous blood pressure, cardiac index, stroke
volume and systemic resistance), peripheral tissue oxygenation and cerebral
tissue oxygenation will be monitored noninvasively using the Nexfin® ,
Inspectra®, and Foresight® and O2C® monitoring devices.
Study objective
Determine whether phenylephrine or norepinephrine has superior haemodynamical
effects in ophtalmic surgery
Study design
randomized interventional prospective study
Intervention
Randomization between use of norepinephrine or phenylephrine for hemodynamic
support
Study burden and risks
In this study, we will provide standard anaesthesia during standard clinical
practice. Either phenylephrine or norepinephrine is routinely used as
haemodynamical support in ophtalmic surgery, depending on the preference of the
anaesthetist. Whether the patient will be treated with phenylephrine or
norepinephrine will be randomly determined. All additional monitoring devices
are noninvasive.
This study will not extent the burden for patients. As both agents are
routinely used, patients will have no additional risk or advantage compared to
clinical practice
hanzeplein 1, Groningen
9713 GZ
NL
hanzeplein 1, Groningen
9713 GZ
NL
Listed location countries
Age
Inclusion criteria
All patients undergoing ophtalmic surgery and requiring general anaesthesia.
withe:
-diabetes
-cardiovascular disease
>55 years
All patients: age > 18 years and older
Exclusion criteria
Patient refusal;- Patient < 18 years
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2011-004229-28-NL |
| CCMO | NL37997.042.11 |