Acute postoperative pain MedDRA version: 19.0 Level: LLT Classification code 10002323 Term: Anesthesia general System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Ultiva
Pharmaceutical Form: Powder for concentrate for solution for injection/infusion
INN or Proposed INN: REMIFENTANIL
CAS Number: 132875-61-7
Concentration unit: µg/kg microgram(s)/kilo
Sponsors
Fundació Hospital Vall Hebron Institut de Recerca
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with ages between 18-75 years. - ASA I-II-III. - Body mass index (BMI ) less than 35 kg / m2 for women and 42 kg / m2 in men. - Major gynecological surgery abdominal hysterectomy laparoscopic or robotic radical prostatectomy. - Control Technology -TCI general anesthesia TIVA (total intravenous anesthesia by infusion systems controlled by computer). - Patients enroll in other clinical investigations can participate 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 154 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: - Patients who do not accept their participation in this clinical trial. - Patients who do not have legal capacity. - Morbid obesity (BMI > 35 kg / m2 in women and > 42 kg / m2 in men). - Basal values ??of systolic blood pressure = 95 mmHg or a heart rate = 60x ' . -Disorders of conduct or anxiety-depressive syndrome. - Treatment with chronic psychotropic drugs or opiates. - Pregnancy - Background Of alcohol abuse . - Documented allergy to morphic drugs , paracetamol, metamizol and dexketoprofen. - Visual secondary alterations to neurological pathologies, retinopatía diabetic and surgery or anomalies of the iris. - Neurological impairment at the level of the midbrain.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assay if the monitoring of intraoperative analgesia through pupilometry (AlgiScan) or guided by electroencephalography (qNOX) compared with the standar hemodynamics monitoring improves the conduction of the general anesthesia and the management of post-surgery acute pain.;Secondary Objective: - To compare the efficacy of intraoperative analgesia monitoring through pupilometry ( AlgiScan ) versus electroencephalography ( qNOX ) . - To demostrate that the number of analgesics needed by the patient during the postoperative period is less in those which have been subjected to intraoperative monitoring with pupilometry or qNOX in comparation with the group that the intraoperative analghesia has been controlled with hemodynamic criteria;Primary end point(s): - Pupillometry (RDP ) : pupillary diameter in mm . Constant quantitative variable - qNOX: Index adimensional. Constant quantitative variable - Remifentanil dose - Non invasive Blood Pressure - Heart Rate (FC);Timepoint(s) of evaluation of this end point: Continously during the surgery procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Dose of propofol - Demographic data - Biometric data - Duration of the surgery - Duration of the anesthesia - Acute postoperative pain ;Timepoint(s) of evaluation of this end point: - Demographic data; Biometric data: beggining of the trial - Duration of the surgery; Dose of propofol; Duration of the anesthesia: during the surgery procedure - Acute postoperative pain : at different timepoints until complete 12 hours follow-up. | — |
Countries
Spain
Contacts
Public ContactDra. Ana M. Abad Torrent
Hospital Universitario Vall Hebron - Servicio de Anestesiología y Reanimación
Outcome results
None listed