Phenylephrine Versus Norepinephrine in Ophthalmic Surgery

University Medical Center Groningen (UMCG)

Status: Completed

Conditions: Bloodpressure

Treatments: Drug: phenylephrine; Drug: norepinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT01609491

PheNor-001

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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60 participants in 2 patient groups

phenylephrine

Active Comparator group

Description:

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

Treatment:

Drug: phenylephrine

norepinephrine

Active Comparator group

Description:

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

Treatment:

Drug: norepinephrine