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
  Purpose

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.


Condition Intervention
Bloodpressure
Drug: phenylephrine
Drug: norepinephrine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Comparison of the Effects of Phenylephrine and Norepinephrine on Hemodynamics and Tissue Oxygenation in Patients Undergoing Ophthalmic Surgery

Resource links provided by NLM:


Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • the haemodynamical effects of norepinephrine and phenylephrine during ophthalmic surgery [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: January 2012
Study Completion Date: December 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01609491

Locations
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9713gz
Sponsors and Collaborators
University Medical Centre Groningen
Investigators
Principal Investigator: Alain Kalmar, Dr Anesthesiology
  More Information

No publications provided

Responsible Party: MMRF Struys, Prof. dr, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01609491     History of Changes
Other Study ID Numbers: PheNor-001
Study First Received: January 17, 2012
Last Updated: April 4, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Norepinephrine
Phenylephrine
Oxymetazoline
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-1 Receptor Agonists
Cardiotonic Agents
Mydriatics
Nasal Decongestants
Respiratory System Agents
Protective Agents

ClinicalTrials.gov processed this record on July 10, 2014