Phenylephrine Versus Norepinephrine in Ophthalmic Surgery

Comparison of the Effects of Phenylephrine and Norepinephrine on Hemodynamics and Tissue Oxygenation in Patients Undergoing Ophthalmic Surgery

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01609491

Enrollment

Registered

2012-06-01

Start date

2012-01-31

Completion date

2012-12-31

Last updated

2024-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bloodpressure

Brief summary

In ophthalmic 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.

Interventions

DRUGphenylephrine

If the mean arterial pressure drops below 20% of the baseline value and/or below 90 mmHg, a syringe pump with phenylephrine or norepinephrine (depending on randomisation) will be started. The anaesthetist will be blinded for the type of vasopressor. Concentrations phenylephrine (20 µg /ml) of Norepinephrine (10 µg/ml) will be used in the syringes

DRUGnorepinephrine

If the mean arterial pressure drops below 20% of the baseline value and/or below 90 mmHg, a syringe pump with norepinephrine (depending on randomisation) will be started. The anaesthetist will be blinded for the type of vasopressor. Concentrations Norepinephrine (10 µg/ml) will be used in the syringes

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

Patients requiring general anaesthesia for ophthalmic surgery. * Age \> 18 years and older * Diabetes or cardiovascular disease or age \>55 years

Exclusion criteria

* Patient refusal * Patient \< 18 years

Design outcomes

Primary

Measure	Time frame
the haemodynamical effects of norepinephrine and phenylephrine during ophthalmic surgery	1 day

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026