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Clinical Trials/EUCTR2007-000968-25-DE
EUCTR2007-000968-25-DE
Active, not recruiting
Phase 1

Prospective, blind-observer, randomised clinical study to investigate and compare the efficacy of intrathecal plain solutions containing Chloroprocaine 1% (50 mg) versus Bupivacaine 0.5% (10mg)

Sintetica SA0 sites0 target enrollmentNovember 12, 2008
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ConditionsPatients undergoing elective short duration (<40 min) low abdominal (in gynaecological and urological disciplines) or lower limbs (no more than 1/3 of cases) surgery.MedDRA version: 9.1Level: LLTClassification code 10030858Term: Operation NOS
DrugsCarbostesin® 0.5%

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Patients undergoing elective short duration (<40 min) low abdominal (in gynaecological and urological disciplines) or lower limbs (no more than 1/3 of cases) surgery.
Sponsor
Sintetica SA
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 12, 2008
End Date
November 19, 2008
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Male/female patients scheduled for short duration (less than 40 min) low abdominal or low extremities (no more than 1/3 of cases) surgery under spinal anaesthesia,
  • •18\-80 years old;
  • •18\=BMI\=32 kg/m2;
  • •ASA physical status I\-II;
  • •Ability to comprehend the full nature and purpose of the study, including possible risks and side effects;
  • •Ability to co\-operate with the Investigator and to comply with the requirements of the entire study;
  • •Signed written informed consent prior to inclusion in the study
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

  • •Clinically relevant abnormalities at ECG (12 leads);
  • •Clinically relevant abnormal physical findings and clinically relevant abnormal laboratory values indicative of physical illness/es that in the opinion of the Investigator might interfere with the aim of the study
  • •Ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients
  • •Ascertained or presumptive hypersensitivity to the amide type of anaesthetics
  • •ASA physical status III, IV or V;
  • •Patients requiring further anaesthesia (i.e. gas products);
  • •Lactating females;
  • •Positive pregnancy test at screening
  • •History of neuromuscular diseases to the lower extremities,
  • •Contraindication to spinal anaesthesia;

Outcomes

Primary Outcomes

Not specified

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