Phenylephrine Versus Norepinephrine in Ophthalmic Surgery

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.

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Key information

Conditions

Bloodpressure

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Groningen

Groningen, 9713gz, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phenylephrine

Drug

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

norepinephrine

Drug

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

Primary outcomes

the haemodynamical effects of norepinephrine and phenylephrine during ophthalmic surgery

Time frame: 1 day

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Jun 1, 2012
Registry last updated: Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed