Phenylephrine Versus Norepinephrine in Ophthalmic Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MMRF Struys, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01609491
First received: January 17, 2012
Last updated: April 4, 2014
Last verified: April 2014

January 17, 2012
April 4, 2014
January 2012
June 2012   (final data collection date for primary outcome measure)
the haemodynamical effects of norepinephrine and phenylephrine during ophthalmic surgery [ Time Frame: 1 day ] [ Designated as safety issue: No ]
the haemodynamical effects of norepinephrine and phenylephrine during ophtalmic surgery [ Time Frame: 1 day ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01609491 on ClinicalTrials.gov Archive Site
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Phenylephrine Versus Norepinephrine in Ophthalmic Surgery
Comparison of the Effects of Phenylephrine and Norepinephrine on Hemodynamics and Tissue Oxygenation in Patients Undergoing 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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Interventional
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Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Bloodpressure
  • Drug: 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
  • Drug: 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
  • Active Comparator: 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
    Intervention: Drug: phenylephrine
  • Active Comparator: 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
    Intervention: Drug: norepinephrine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01609491
PheNor-001
No
MMRF Struys, University Medical Centre Groningen
University Medical Centre Groningen
Not Provided
Principal Investigator: Alain Kalmar, Dr Anesthesiology
University Medical Centre Groningen
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP