Phenylephrine Versus Norepinephrine in Ophthalmic Surgery

Not Applicable

Completed

• Conditions: Bloodpressure
• Interventions: Drug: norepinephrine; Drug: phenylephrine

• Registration Number: NCT01609491
• Lead Sponsor: University Medical Center Groningen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-17
• Study First Submitted QC: 2012-05-30
• Primary Completion: 2012-06
• Study First Posted: 2012-06-01
• Study Completion: 2012-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
norepinephrine	norepinephrine	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
phenylephrine	phenylephrine	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

Primary Outcome Measures

Name	Time	Method
the haemodynamical effects of norepinephrine and phenylephrine during ophthalmic surgery	1 day

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands