Clinical TrialChronic PainPlaceboEsketamineEsketamineCompleted

Effect of Intravenous S-ketamine on Opioid Consumption

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.

Target Enrollment
345 participants
Study Type
Phase NA interventional
Design
Randomized, quadruple Blind

Detailed Description

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.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Placebo

inactive

Bolus 0.9% saline then continuous saline infusion until 30 min before end of surgery.

Interventions

  • Placebo
    via IV• bolus + infusion

    Bolus 0.9% saline then continuous saline infusion; infusion stopped 30 min before end of surgery.

Low-dose S-ketamine

experimental

Bolus 0.5 mg/kg S-ketamine followed by 2 µg/kg/min infusion until 30 min before end of surgery.

Interventions

  • Esketamine0.5 mg/kg
    via IV• bolus + infusion

    Bolus 0.5 mg/kg; infusion 2 µg/kg/min until 30 min before end of surgery.

High-dose S-ketamine

experimental

Bolus 0.5 mg/kg S-ketamine followed by 4 µg/kg/min infusion until 30 min before end of surgery.

Interventions

  • Esketamine0.5 mg/kg
    via IV• bolus + infusion

    Bolus 0.5 mg/kg; infusion 4 µg/kg/min until 30 min before end of surgery.

Participants

Ages
18 – 99
Sexes
female

Inclusion Criteria

  • Inclusion Criteria:\n1. Female patients with an American Society of Anesthesia (ASA) physical status I-II\n2. Scheduled for elective breast cancer surgery

Exclusion Criteria

  • Exclusion Criteria:\n1. Patients unable to understand the study procedure or unable to give informed consent\n2. Concurrent analgesic or sedative medication\n3. History of chronic pain\n4. History of psychiatric disorders\n5. History of alcohol or drug abuse\n6. Allergy to the study medication\n7. Pregnant or breastfeeding\n8. BMI >30 or <18 kg/m2\n9. Severe cardiac, pulmonary, hepatic or renal dysfunction\n10. Intracranial hypertension

Study Details

  • Status
    Completed
  • Phase
    Phase NA
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment345 participants
  • Timeline
    Start: 2021-10-07
    End: 2024-07-07
  • Compounds
    PlaceboEsketamineEsketamine
  • Topic
    Chronic Pain

Locations

Second Affiliated Hospital of Anhui Medical University — Hefei, China

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