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

June 30, 2011
June 20, 2014
March 2011
May 2013   (final data collection date for primary outcome measure)
number of hypotension episodes [ Time Frame: 48h after infusion ] [ Designated as safety issue: Yes ]
at the end of solution infusion
Same as current
Complete list of historical versions of study NCT01533662 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Prophylactic Phenylephrine Infusion for Preventing Hypotension During Spinal Anesthesia
Phase 2 Study Evaluating the Prophylactic Phenylephrine Infusion for Preventing Hypotension During Spinal Anesthesia for Lower Limb Orthopedic Surgery in the Elderly Patients

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Orthopedic Surgery of Lower Limb
  • Drug: phenylephrine infusion
    patients from 60 to 75 years receiving 100micrograms of phenylephrine infusion
  • Drug: patients receiving saline infusion
    patients more than 60 years receiving 100micrograms of saline infusion
  • Experimental: phenylephrine
    patients more than 60 years receiving 100micrograms of phenylephrine infusion (2 groups 60-75 years and more than 75 years)
    Intervention: Drug: phenylephrine infusion
  • Placebo Comparator: placebo
    patients more than 60 years receiving saline infusion (2 groups 60-75 years and more than 75)
    Intervention: Drug: patients receiving saline infusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
September 2013
May 2013   (final data collection date for primary outcome measure)

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.
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01533662
0900103
No
University Hospital, Toulouse
University Hospital, Toulouse
Not Provided
Principal Investigator: Vincent Minville, PhD CHU Toulouse
University Hospital, Toulouse
June 2014

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