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Compared Efficacy and Tolerance of Two Vasopressors Used to Treat Preoperative Hypotension During Carotid Surgery (VP-hTA-XCar)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University Hospital, Clermont-Ferrand
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT01794273
First received: February 15, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  Purpose

The effects on brain perfusion of the two currently vasopressors used to treat accidental hypotension occurring during carotid surgery (i.e. ephedrine and phenylephrine) is not known, but a disadvantage to use phenylephrine is suspected, due to its mechanism of action and according to published reports


Condition Intervention Phase
Endovascular Carotid Surgery;
Preoperative Hypotension;
Drug: ephedrine and phenylephrine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Compared Efficacy and Tolerance of Two Vasopressors Used to Treat Preoperative Hypotension During Carotid Surgery. Prospective Randomised Controlled and Single Centre Trial

Resource links provided by NLM:


Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Cerebral oxygen saturation (SctO2) [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of post-treatment hypotension [ Time Frame: At day 1 ] [ Designated as safety issue: Yes ]
  • Incidence of post-treatment bradycardia [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]
  • Postoperative morbidity: cardiovascular, cerebral, renal, surgical [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]
  • Postoperative recovery [ Time Frame: at day 1 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: July 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ephedrine
This is a randomised trial comparing ephedrine and phenylephrine as used for accidental hypotension occurring during carotid surgery, on cerebral perfusion, assessed by near-infrared spectroscopy (NIRS).
Drug: ephedrine and phenylephrine
Experimental: phenylephrine
This is a randomised trial comparing ephedrine and phenylephrine as used for accidental hypotension occurring during carotid surgery, on cerebral perfusion, assessed by near-infrared spectroscopy (NIRS).
Drug: ephedrine and phenylephrine

Detailed Description:

This is a randomised trial comparing ephedrine and phenylephrine as used for accidental hypotension occurring during carotid surgery, on cerebral perfusion, assessed by near-infrared spectroscopy (NIRS).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age over 18 ASA score I-III Planned carotid endarteriectomy under general anaesthesia Hypotension defined as SAP < 90 mm Hg during general anaesthesia Informed consent to the trial Protected by the French health welfare

Exclusion Criteria:

  • Emergency surgery Cardiac arrythmia Pregnancy or breastfeeding Allergy to the tested treatment Allergy to hydroxyethylstarch Allergy to the glue of the NIRS's electrodes Current medication: MAOI, intranasal vasopressors
  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: NCT01794273

Contacts
Contact: Patrick LACARIN 04.73.75.11.95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Charlotte BAUD University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT01794273     History of Changes
Other Study ID Numbers: CHU-0147, 2012-001827-11
Study First Received: February 15, 2013
Last Updated: February 15, 2013
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Ephedrine
Phenylephrine
Vasopressor
Carotid surgery
Hypotension
Haemodynamics
Brain ischemia
Tissue perfusion
Stroke
anaesthesia;

Additional relevant MeSH terms:
Hypotension
Cardiovascular Diseases
Vascular Diseases
Ephedrine
Oxymetazoline
Phenylephrine
Pseudoephedrine
Vasoconstrictor Agents
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiotonic Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Stimulants
Molecular Mechanisms of Pharmacological Action
Mydriatics
Nasal Decongestants
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Sympathomimetics
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014