Preoperative Methadone Single Dose Reduces Postoperative Morphine Consumption.

K

Kantonsspital Baden

Status and phase

Completed
Phase 4

Conditions

Pain, Postoperative

Treatments

Drug: Methadone

Study type

Interventional

Funder types

Other

Identifiers

NCT03529032
Ref.Nr.EK:2011/052

Details and patient eligibility

About

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.

Full description

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.

Enrollment

160 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

160 participants in 2 patient groups

Fentanyl group
No Intervention group
Description:
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 group
Description:
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.
Treatment:
Drug: Methadone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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