Anesthesia With Propofol, Dexmedetomidine and Lidocaine Infusions for Laparoscopic Cholecystectomy
Opioids may attenuate postoperative hyperalgesia and postoperative nausea and vomiting. Our hypothesis is: opioid-free total intravenous anesthesia with propofol, dexmedetomidine and lidocaine infusions for laparoscopic cholecystectomy may achieve comparable hemodynamic stability during laparoscopy, with lower postoperative analgesic consumption and incidence of postoperative nausea and vomiting.
Drug: Dexmedetomidine and lidocaine
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Opioid-free Total Intravenous Anesthesia With Propofol, Dexmedetomidine and Lidocaine Infusions for Laparoscopic Cholecystectomy; Comparison With Propofol, Remifentanil Infusions|
- Postoperative fentanyl consumption [ Time Frame: 6 hours after extubation ] [ Designated as safety issue: No ]Patients will use a Patient controlled analgesia (PCA) device for 6 hours after extubation
- Recovery time [ Time Frame: 2 hours after cessation of anesthesia infusions ] [ Designated as safety issue: Yes ]Extubation time after cessation of anesthesia infusions and discharge time from postanesthesia care unit (PACU) after extubation
- Postoperative nausea and vomiting [ Time Frame: Postoperative 24 hours ] [ Designated as safety issue: No ]
|Study Start Date:||June 2012|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Opioid-free anesthesia (Group DL) with dexmedetomidine (0.6 mg/kg loading, 0.3 mg/kg/h infusion), lidocaine (1.5 mg/kg loading, 2 mg/kg/h infusion), and propofol infusions (3-12 mg/kg/h).
|Drug: Dexmedetomidine and lidocaine|
Opioid-based anesthesia (Group RF) with single dose fentanyl (2μg/kg), remifentanil (0.25μg/kg/min), and propofol infusions (3-12 mg/kg/h).
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01833819
|Bezmialem Vakif University Faculty of Medicine|
|Istanbul, Turkey, 34093|