This study aims to investigate the effect of a clinically used dose of Pregabalin on the Cp50 of propofol to provide more information to clinicians using this adjunctive drug in the perioperative setting.
Conditions
Interventions
Trade Name: Pregabalin ratiopharm 300 mg Hartkapseln
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Pregabalin
CAS Number: 148553-50-8
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Medical University of Vienna, Department of Anaesthesia, Critical Care and Pain Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: We will include only adult patients aged 30-60 years of the ASA classes 1-2 and a BMI between 18.5 and 30, undergoing elective surgery under general anaesthesia with a skin incision of at least 3 cm at the trunk. 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 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients not able to understand the study procedure, patients needing premedication with sedative or analgesic drugs, patients with a history of chronic pain, patients that regularly take pregabalin, patients in whom propofol or pregabalin is contraindicated, patients with a known allergy to one of the study medications and pregnant or breastfeeding patients cannot be included in the study. Also, patients with a history of intraoperative awareness will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study aims to investigate the effect of a clinically used dose of Pregabalin on the Cp50 of propofol to provide more information to clinicians using this adjunctive drug in the perioperative setting.;Secondary Objective: Not applicable;Primary end point(s): Response to skin incision;Timepoint(s) of evaluation of this end point: At skin incision | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Blood samples for plasma propofol concentrations will be taken 15 and 20 minutes after induction of anaesthesia. Blood samples for the serum pregabalin concentration will be taken immediately before skin incision. All samples will be taken via the arterial line to minimise trauma to the patients. Arterial blood sampling for the determination of plasma or serum concentrations of drugs that are applied continuously via an intravenous line is common practice as it reduces the risk of concentration fluctuations that may be present in the venous system. Heart rate, oxygen saturation, blood pressure, BIS values, endtidal CO2 concentration and body temperature will be documented every minute from the start of anaesthesia until two minutes after skin incision. Two minutes before and after the skin incision values will be documented every 30 seconds to allow for more precise monitoring during this critical phase. Furthermore, the exact location of the skin incision and detailed description of the motor response to skin incision (which extremities moved, character of the movement) will be documented.;Timepoint(s) of evaluation of this end point: From the start of anaesthesia until 2 minutes after skin incision | — |
Countries
Austria
Contacts
Public ContactDepartment of Anaesthesia
Medical University of Vienna
Outcome results
None listed