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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.
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:

U.S. FDA Resources

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

ClinicalTrials.gov processed this record on May 21, 2013