This explorative post hoc analysis included patients randomized in the DEX-2-TKA trial
      (NCT03506789) who were operated under general anesthesia with remifentanil and propofol.
      Patients having general anesthesia with sevoflurane were excluded. As the two groups
      receiving preoperative dexamethasone were identical at the time of outcome assessment, they
      were merged to one and were compared with placebo.

Effect of Dexamethasone Shortly Before Surgery on the Intraoperative Dose of Remifentanil

Perioperative Pain

The DEX-2-TKA was a randomized, blinded, placebo-controlled, multicenter trial in
      participants undergoing primary TKA conducted to investigate the effects of dexamethasone on
      morphine consumption, levels of postoperative pain, and harm. The methodology has been
      described in detail in the primary publication (ref), the protocol article and in the
      statistical analysis plan. In short, the trial was conducted at one private and four public
      Danish hospitals. Patients were randomized into one of three groups receiving either:
      Dexamethasone + placebo, dexamethasone + dexamethasone or placebo + placebo in a 1:1:1 ratio.
      The first dose of trial medication (intravenous dexamethasone 24 mg or placebo) was
      administered immediately after onset of anesthesia. Twenty-four hours after end of surgery,
      the second dose (dexamethasone 24 mg or placebo) was administered.

      As the two groups receiving preoperative dexamethasone were identical at the time of outcome
      assessment for thi post-hoc analysis, they were merged to one and were compared with placebo
      yielding a ratio of 2:1 between the groups recieving dexamethsone and the placebo group.

      Patients received either spinal anesthesia or general anesthesia (remifentanil and propofol
      were preferred). Before end of surgery all patients received ondansetron iv 4 mg. For
      patients in general anesthesia, sufentanil (0.3 μg/kg) was administered. All participants
      were provided with a patient-controlled analgesia pump (morphine 1 mg/mL, bolus 2 mg,
      lock-out 6 minutes, no background infusion) for 24 hours postoperatively. Additional boluses
      of 2 mg morphine on participant request were allowed the first hour after cessation of
      anesthesia. All participants received a protocolled non-opioid analgesic pain alleviation
      regime comprised of oral paracetamol 1 g and ibuprofen 400 mg given 1 hour before and every 6
      hours after surgery and the surgeon administered local infiltration analgesia
      intraoperatively according to a standardized regimen.

      The present explorative post hoc analysis included patients randomized in the DEX-2-TKA trial
      who were operated under general anesthesia with remifentanil and propofol. Patients having
      general anesthesia with sevoflurane were excluded.

Dexamethasone

Isotonic saline

Effect of Dexamethasone Shortly Before Surgery on the Intraoperative Dose of Remifentanil in Total Knee Arthroplasty Patients Operated Under General Anesthesia: A Post-hoc Sub-study Analysis of the Randomized DEX-2-TKA Trial

Effect of Dexamethasone Shortly Before Surgery on the Intraoperative Dose of Remifentanil

About this trial

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Placebo

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Trial Timing

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