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Clinical Trials/EUCTR2015-002843-32-NL
EUCTR2015-002843-32-NL
Active, not recruiting
Phase 1

The haemodynamic effects of spinal anaesthesia with versus without sufentanil added to bupivacaine heavy - SPINAL study: Spinal anaesthesia Investigation of Opioid anaesthesia versus Local anaesthesia

Not provided0 sitesSeptember 14, 2015
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ConditionsPatient undergoing surgery for which they receive spinal anaesthesiaTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
DrugsSufentanilBupivacaine heavy 0,5%

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Patient undergoing surgery for which they receive spinal anaesthesia
Sponsor
Not provided
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 14, 2015
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Not provided

Eligibility Criteria

Inclusion Criteria

  • •Patients undergoing surgery with spinal anaesthesia.
  • •18\-90 years old
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 300
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range 300

Exclusion Criteria

  • •\- ASA IV\-V
  • •\- Patients younger than 18 years or older than 90 years
  • •Contra\-indication for spinal anaesthesia:?
  • •??Severe aortic valve stenosis or severe heart disease
  • •\- Local infection at puncture site
  • •\- Allergy for local anaesthetics or opioids

Outcomes

Primary Outcomes

Not specified

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