Preoperative Methadone Single Dose Reduces Postoperative Morphine Consumption.

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

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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