Trial | NCT03529032  Report issue

Title

Preoperative Methadone Single Dose Reduces Postoperative Morphine Consumption.
A Preoperative Methadone Single Dose for Moderately to Severely Painful Surgery Reduces Postoperative Morphine Consumption Results From a Double-blind Pragmatic Clinical Trial

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    160
The aim of this study was to evaluate the effect of intraoperative methadone on postoperative analgesic requirements, pain scores and patient satisfaction in comparison to standard intraoperative pain control with fentanyl.
Patients of both genders and up to age 75 and ASA classification III were enrolled, when undergoing moderately to severely painful surgery scheduled for ≥90 minutes in general anaesthesia. Patients were randomized to receive either a single shot of methadone (0.2mg/kg) or fentanyl (0.003mg/kg) for induction of anesthesia. In cases of insufficient intraoperative analgesia repeated fentanyl administration was possible. Postoperative analgesia was provided with patient controlled morphine in both groups (PCA = Patient Controlled Analgesia). Pain was assessed using the numerical rating scale (NRS) at rest and after coughing, at 15 minutes post extubation, and repeated every 6 hours up to 72 hours postoperatively. The levels of sedation and nausea/vomiting were also evaluated in parallel.
Study Started
Mar 31
2012
Primary Completion
Jul 31
2013
Study Completion
May 31
2018
Last Update
Jul 03
2018

Drug Methadone

methadone for control postoperative pain

Fentanyl group No Intervention

Drug: Fentanyl Fentanyl group 3µg/kg to start surgery TIVA: general anesthesia will be based on Fentanyl an Propofol, titrated to achieve bispectral index (BIS) between 40-60.

methadone group Experimental

Drug: methadone methadone group 0.2mg/kg to start surgery TIVA: general anesthesia will be based on Fentanyl an Propofol, titrated to achieve bispectral index (BIS) between 40-60.

Criteria 

Inclusion Criteria:

informed consent
Patients of both genders and up to age 75 and ASA classification III were enrolled, when undergoing moderately to severely painful surgery scheduled for ≥90 minutes in general anaesthesia.
german speaking patients

Exclusion Criteria:

patients including other studies
pregnant
breast feeding
patients in methadone substitution therapy
dependent drug user
patients with BMI greater than 36kg/m2
patients with chronic or acute renal failure with serum creatinine greater than 400µmol/L
patients with liver insufficiency or failure
alcoholics
patients with acute heard attack
No Results Posted