Effect of Intravenous S-ketamine on Opioid Consumption

  • STATUS
    Recruiting
  • days left to enroll
    5
  • participants needed
    825
  • sponsor
    The Second Hospital of Anhui Medical University
Updated on 25 March 2022

Summary

Female patients with an American Society of Anesthesia (ASA) physical status I-II, scheduled for elective breast cancer surgery will be included in the study. Subjects will be randomly assigned to one of three groups: the placebo group, the low-dose S-ketamine group, and the high-dose S-ketamine group. The primary outcome is the consumption of sufentanil during the surgery.

Description

All patients will be scheduled to a propofol-remifentanil general anesthesia and receive non-steroid anti-inflammatory drug before incision. Bolus sufentanil will be administered according to the blood pressure, heart rate and bispectral index perioperatively. Patients unable to understand the study procedure or unable to give informed consent, with concurrent analgesic or sedative medication, with history of chronic pain, psychiatric disorders, or alcohol or drug abuse, with an allergy to the study medication, who are pregnant or breast feeding, with a BMI >30 and <18 kg/m2, with severe cardiac, pulmonary, hepatic or renal dysfunction, with intracranial hypertension will be excluded.

Subjects will be randomly assigned to one of three groups: the placebo group, the low-dose S-ketamine group, and the high-dose S-ketamine group. The study medication will be administered in a bolus injected over 30 s after induction, followed by continuous infusion, which started after the initial bolus. The placebo group will receive a bolus of 0.9% saline, followed by continuous infusion of 0.9% saline. The low-dose ketamine group will be administered a bolus of 0.5 mg/kg S-ketamine in saline, followed by 2μg/kg/min S-ketamine in saline, whereas the high-dose ketamine group will be administered a bolus of 0.5 mg/kg S-ketamine in saline, followed by continuous infusion of 4μg/kg/min S-ketamine in saline. The syringes and infusions will be identical for all of the groups and will run at the same rate in all subjects to enable blinding of the investigators. Study medication will be terminated 30 min prior to the end of the surgery. After surgery and in the postanesthesia care unit, patients will be asked about their pain level on a numeric rating scale (NRS), and about the presence of intraoperative awareness, nausea, vomiting, and hallucinations. Rescue analgesia of sufentanil will be provided when NRS ≥ 4 or patients require. Pain level will also be assessed at 0.5, 2, 4, 6, 12 and 24 hour postoperatively as well as 3 and 6 month after the surgery. Depression scale will be evaluated before the surgery and in the 7th postoperative day.

Details
Condition Breast Cancer Surgery
Treatment Placebo, S-ketamine (low dose), S-ketamine (high dose)
Clinical Study IdentifierNCT05060068
SponsorThe Second Hospital of Anhui Medical University
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Female patients with an American Society of Anesthesia (ASA) physical status I-II
Scheduled for elective breast cancer surgery

Exclusion Criteria

Patients unable to understand the study procedure or unable to give informed consent
with concurrent analgesic or sedative medication
with history of chronic pain
with history of psychiatric disorders
with history of alcohol or drug abuse
with an allergy to the study medication
who are pregnant or breast feeding
with a BMI >30 and <18 kg/m^2
with severe cardiac, pulmonary, hepatic or renal dysfunction
with intracranial hypertension
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