Intraoperative analgesia during general anesthesia
Conditions
Interventions
Trade Name: Dexdor
Product Name: Dexmedetomidine
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: DEXMEDETOMIDINE
CAS Number: 113775-47-6
Concentration unit: mg/kg/h milligram(s)/kilogr
Sponsors
Erasme University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Included patients will be American Society of Anesthesiologists (ASA) grades 1-2 undergoing scheduled maxilloafacial, plastic, ear-nose-throat, thyroid, or cervicofacial surgery anticipated to last at least two hours. A total of 50 patients per group will be included. 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: ASA score >2, use of regional anesthesia, preoperative organ dysfunction, patients with non-regular cardiac rhythm, implanted pacemakers, emergent surgery, pregnancy or lactation, allergy or intolerance to any of the study drugs, and patient’s refusal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary outcome is quantity of administered remifentanil;Secondary Objective: Secondary outcomes will include postoperative opioid administration, opioid associated complications, hemodynamics, and hospital length of stay.;Primary end point(s): The primary outcome is intraoperative consumption of remifentanil to maintain NOL-Index between 10 and 25. ;Timepoint(s) of evaluation of this end point: Intraoperative period (less than 24h) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Intraoperative outcomes will include: estimated blood loss, use and amount of vasoactive drugs used (ephedrine/phenylephrine/noradrenaline), use and amount of hypotensive drugs used (nicardipine/esmolol), quantity of propofol, quantity of fluids, time to extubation of patient, hypotension and duration (defined as MAP90) for a period at least 3 minutes, blood pressure, HR, and NOL-Index measurement during key intraoperative periods (before induction, after induction, after intubation, before incision, after incision, every 15 minutes after incision, after end of surgery, and after reversal of anesthesia). Post-operative variables include postoperative opioid consumption, occurrence of postoperative opioid-related side effect (PONV within the first 24 h, postoperative hypoxemia (need within 24h postop to have supplemental oxygen (to maintain sat >94%), postoperative hypopnea (defined as less than 8 rpm), postoperative ileus (absence of flatus or stools throughout the first 48 postoperative hours), postoperative cognitive dysfunction using CAM-ICU (i.e. acute onset or fluctuating course + inattention and either disorganized thinking or altered level of consciousness), pruritus, postoperative hyperalgesia (addressed using calibrated von Frey hairs), time to fit for PACU discharge, postoperative Ramsay sedation score (at arrival then every 30 minutes PACU), PACU length of stay (LOS), fit for discharge PACU LOS based on Aldrete Score, postoperative complications, hospital LOS, and fit for discharge hospital LOS (patient is fully oriented and able to move without nursing support, hemodynamically stable, laboratory parameters with no sign of increasing organ dysfunction or infection, and no clinical signs of active wound infection). * Patients that have chronic hypertension or that are 65 years of age or older will have a MAP threshold of 75mmHg (and not 65mmHg).;Timepoint(s) of evaluation of this end point: Intraoperative endpoints: less than 24h P | — |
Countries
Belgium
Contacts
Public ContactDepartment of Anesthesia
Erasme University Hospital
Outcome results
None listed