Prophylactic Phenylephrine Infusion for Preventing Hypotension During Spinal Anesthesia

NCT01533662 | Completed Phase 2

• 1 other identifier: 0900103
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Orthopedic Surgery of Lower Limb

Keywords

phenylephrine; hypotension; spinal anesthesia; lower limb orthopedic surgery

Outcome Measures

Primary Outcomes (1)

• number of hypotension episodes

  at the end of solution infusion

  48h after infusion

Secondary Outcomes (3)

• number of episodes of severe hypotension

  48h after infusion

• cardiovascular events

  48h after infusion

• neurologic events

  48h after infusion

Study Arms (2)

phenylephrine

EXPERIMENTAL

patients more than 60 years receiving 100micrograms of phenylephrine infusion (2 groups 60-75 years and more than 75 years)

Drug: phenylephrine infusion

placebo

PLACEBO COMPARATOR

patients more than 60 years receiving saline infusion (2 groups 60-75 years and more than 75)

Drug: patients receiving saline infusion

Interventions

phenylephrine infusion DRUG

patients from 60 to 75 years receiving 100micrograms of phenylephrine infusion

phenylephrine

patients receiving saline infusion DRUG

patients more than 60 years receiving 100micrograms of saline infusion

placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• dementia
• anemia less than 10grams per deciliter
• hypertension
• hemostasis disorders
• infection at the puncture
• allergy to local anesthetic,
• patient under anticoagulant.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU Toulouse

Toulouse, Toulouse, 31059, France

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Vincent Minville, PhD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2011
• First Posted: February 15, 2012
• Study Start: March 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: September 1, 2013
• Last Updated: June 23, 2014

Record last verified: 2014-06

Locations

FR (1)