Does Pregabalin reduce preoperative anxiety: a placebo controlled study - Study of Pregabalin

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-002890-31-AT

Enrollment

Registered

2006-07-21

Start date

2006-08-25

Completion date

Unknown

Last updated

2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients should receive Pregabalin or placebo as premedication one hour before ambulatory elective surgery. After this they have to assess their anxiety and pain with Visual Analog Scale (VAS) for anxiety and pain und Amsterdam Preoperative Anxiety and Informtion Scale(APAIS)

Interventions

Trade Name: Lyrica Product Name: Lyrica Product Code: Pregabalin Pharmaceutical Form: Capsule, hard INN or Proposed INN: PREGABALIN CAS Number: 148553508 Concentration unit: mg milligram(s) Pharmaceut

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ASA 1 - 2, age between 18 and 60, minor ambulatory orthopedic surgery under general anaesthesia, female and male 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: relevant cardiovascular, renal and hepatic deseases, epilepsy, sleeping apnea, pregnancy, containdications to pregabalin, body mass index more than 25

Design outcomes

Primary

Measure	Time frame
Main Objective: We would like to test that a single oral pregabalin dose, given one hour before anesthesia, has an anxiolytic effect in patients undergoing minor orthopedic surgery under general anesthesia. ;Secondary Objective: We would like to show that patients receiving pregabalin need less narcotics and less postoperative pain therapy than without pregabalin.;Primary end point(s): APAIS("Amsterdam Preoperative Anxiety and Information Score")	—

Measure

Time frame

Main Objective: We would like to test that a single oral pregabalin dose, given one hour before anesthesia, has an anxiolytic effect in patients undergoing minor orthopedic surgery under general anesthesia. ;Secondary Objective: We would like to show that patients receiving pregabalin need less narcotics and less postoperative pain therapy than without pregabalin.;Primary end point(s): APAIS("Amsterdam Preoperative Anxiety and Information Score")

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Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026