Randomised, multicentre, parallel-group, quadruple-blind trial (n=345) comparing placebo, low-dose S-ketamine (0.5 mg/kg bolus + 2 µg/kg/min infusion) and high-dose S-ketamine (0.5 mg/kg bolus + 4 µg/kg/min infusion) on intraoperative sufentanil consumption in female breast cancer surgery patients.
Randomised, parallel-group study in female patients undergoing elective breast cancer surgery comparing placebo, low-dose and high-dose intravenous S-ketamine given as a bolus after induction followed by a continuous intraoperative infusion; infusions are stopped 30 minutes before the end of surgery.
Primary outcome is intraoperative sufentanil consumption; secondary assessments include postoperative pain scores (NRS) at 0.5, 2, 4, 6, 12 and 24 hours and at 3 and 6 months, awareness, nausea/vomiting, hallucinations and depression scale at day 7.
Bolus 0.9% saline then continuous saline infusion until 30 min before end of surgery.
Bolus 0.9% saline then continuous saline infusion; infusion stopped 30 min before end of surgery.
Bolus 0.5 mg/kg S-ketamine followed by 2 µg/kg/min infusion until 30 min before end of surgery.
Bolus 0.5 mg/kg; infusion 2 µg/kg/min until 30 min before end of surgery.
Bolus 0.5 mg/kg S-ketamine followed by 4 µg/kg/min infusion until 30 min before end of surgery.
Bolus 0.5 mg/kg; infusion 4 µg/kg/min until 30 min before end of surgery.