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Clinical trial

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

ID
Name
PheNor-001
Description
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.
Trial arms
Trial start
2012-01-01
Estimated PCD
2012-06-01
Trial end
2012-12-01
Status
Completed
Treatment
phenylephrine
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
Arms:
phenylephrine
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
Arms:
norepinephrine
Size
60
Primary endpoint
the haemodynamical effects of norepinephrine and phenylephrine during ophthalmic surgery
1 day
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}
Updated at
2024-04-18

1 organization

2 products

1 indication

Organization
University Medical Center Groningen
Product
phenylephrine
Indication
Blood Pressure
Product
norepinephrine