Prophylactic Phenylephrine Infusion for Preventing Hypotension During Spinal Anesthesia (PPSA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT01533662
First received: June 30, 2011
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

Lower limb orthopedic surgery is commonly realized under spinal anesthesia. This loco-regional anesthesia induces a peripheral vascular resistance decrease by vasodilatation resulting in hypotension. A severe and prolonged hypotension can compromise regional perfusion and worse outcome especially in very elderly patients. Moreover the venous vasodilatation observed after spinal anesthesia decreases cardiac preload resulting in a cardiac output decrease. Several authors had identified the prevention of hypotension as a key role during spinal anesthesia although none prophylactic treatment has been identified. Spinal anesthesia single injection (SA) with low dose of local anesthetic or continuous spinal anesthesia with very low dose bolus injections cause fewer episodes of hypotension. Despite these techniques, hypotension can occur. Phenylephrine is an alpha adrenergic agonist and cause vasoconstriction preventing hypotension. Prophylactic phenylephrine infusion for preventing hypotension has been demonstrated during spinal anesthesia for cesarean delivery. The investigators want to assess for the first time the prophylactic phenylephrine infusion for preventing hypotension in elderly patients undergoing orthopedic lower limb surgery under spinal anesthesia single injection.


Condition Intervention Phase
Orthopedic Surgery of Lower Limb
Drug: phenylephrine infusion
Drug: patients receiving saline infusion
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Phase 2 Study Evaluating the Prophylactic Phenylephrine Infusion for Preventing Hypotension During Spinal Anesthesia for Lower Limb Orthopedic Surgery in the Elderly Patients

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • number of hypotension episodes [ Time Frame: 48h after infusion ] [ Designated as safety issue: Yes ]
    at the end of solution infusion


Secondary Outcome Measures:
  • number of episodes of severe hypotension [ Time Frame: 48h after infusion ] [ Designated as safety issue: Yes ]
    at the end of solution infusion

  • cardiovascular events [ Time Frame: 48h after infusion ] [ Designated as safety issue: Yes ]
    at the end of the solution infusion

  • neurologic events [ Time Frame: 48h after infusion ] [ Designated as safety issue: Yes ]
    at the end of solution infusion


Enrollment: 64
Study Start Date: March 2011
Study Completion Date: September 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: phenylephrine
patients more than 60 years receiving 100micrograms of phenylephrine infusion (2 groups 60-75 years and more than 75 years)
Drug: phenylephrine infusion
patients from 60 to 75 years receiving 100micrograms of phenylephrine infusion
Placebo Comparator: placebo
patients more than 60 years receiving saline infusion (2 groups 60-75 years and more than 75)
Drug: patients receiving saline infusion
patients more than 60 years receiving 100micrograms of saline infusion

Detailed Description:

The aim of this study is to assess the prophylactic phenylephrine infusion for preventing hypotension in elderly patients.

This prospective double blinded randomized control trial will include elderly patients over 60 years undergoing orthopedic lower limb surgery under spinal anesthesia single injection (10 mg of Bupivacaine 0,5% with 5 µg of Sufentanyl). We define 4 groups: (1) Patients from 60 to 75 years receiving 100 µg/min of phenylephrine infusion; (2) patients from 60 to 75 years receiving saline infusion; (3) patients over 75 years receiving 100 µg/min of phenylephrine infusion; (4) patients over 75 years receiving saline infusion. Standard monitoring is applied including noninvasive arterial blood pressure, electrocardiography and pulse oximetry. The vasopressor solution and the saline solution will be prepared in identical 50 mL syringes by an investigator not involved in patient care. The investigator administering the solution and the patient are blinded to the content of the syringe. The velocity of infusion will be the same between groups (1ml/min) and the infusion will start once the spinal anesthesia realized. Arterial blood pressure measurements are realized each 1 minute for the first 20 minutes and then each 5 minutes until the end of surgery. After each measurement of MAP, the infusion is stopped if the MAP is more than baseline, and it is continued or restarted if the MAP is less than or equal to baseline. Anyway the infusion is stopped at the end of motor block. Hypotension is defined as a 20% decrease of mean arterial pressure (MAP). Severe hypotension is defined as a 30% decrease of MAP. Hypertension is defined as MAP > 120% of baseline. Each time there is a MAP measurement showing hypotension while patients are under infusion, a 1 mL IV bolus of phenylephrine 100µg/ml is injected by the anesthesiologist involved in patient care. The total volume of study solution given by infusion and the total volume of phenylephrine given by bolus are recorded.

We want to demonstrate fewer episodes of hypotension and fewer post operatory cardiovascular and neurologic events in the groups receiving prophylactic phenylephrine infusion.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • over 60 years old
  • informed consent
  • lower limb orthopaedic surgery
  • spinal anesthesia

Exclusion Criteria:

  • dementia
  • anemia less than 10grams per deciliter
  • hypertension
  • hemostasis disorders
  • infection at the puncture
  • allergy to local anesthetic,
  • patient under anticoagulant.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01533662

Locations
France
CHU Toulouse
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Vincent Minville, PhD CHU Toulouse
  More Information

No publications provided

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT01533662     History of Changes
Other Study ID Numbers: 0900103
Study First Received: June 30, 2011
Last Updated: June 20, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Toulouse:
phenylephrine
hypotension
spinal anesthesia
lower limb orthopedic surgery

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

ClinicalTrials.gov processed this record on October 16, 2014