Anesthesia for Vascular Access Devices
Condition: Opioid Use, Unspecified; Remifentanil; Sedation Complication; Analgesia; Satisfaction, Patient; Vascular Access Complication
Study type: Interventional

Summary: 
      Our aim was to investigate whether remifentanil use in both infusion and bolus techniques
      could provide sufficient sedation and analgesia without serious adverse effects for central
      venous access device procedures under monitored anesthesia care.
    

Detailed description: 
      The insertion and removal of implantable venous access devices (port-a-cath type) requires
      moderate level of sedation and monitored anesthesia care to prevent pain and anxiety of
      patients during the procedure. According to the American Society of Anesthesiologist Physical
      Status Score, monitored anesthesia care is a planned procedure where a patient undergoes
      local anesthetic infiltration together with sedation and analgesia. Remifentanil is a potent
      synthetic opioid with novel pharmacokinetic properties, including very rapid onset and an
      ultra short duration of action, making it effective for pain relief in short procedures.
      Remifentanil can be administered as either one of the techniques of intravenous continuous
      infusion (CI) or intravenous bolus patient-controlled sedation analgesia (PCSA).In previous
      studies, the insertion or removal of venous access procedures required either local
      anesthesia or low doses of orally administered anxiolytic medication. The infusion of
      remifentanil may cause respiratory depression and analgesic efficacy and safety of
      administration of remifentanil infusion and/or bolus doses of remifentanil during the
      administration of one of the techniques of either CI or PCSA in short term procedures has not
      been well studied. The prospective trials that compare analgesic efficacy and adverse events
      related to intravenous remifentanil consumption in sedation and analgesia of short procedures
      are very limited.

      This study aims to compare level of pain and sedation, total amount of remifentanil
      consumption, bolus doses of remifentanil, patient and surgeon satisfaction, hemodynamic data
      and adverse events of two different techniques of intravenous remifentanil use such as;
      intravenous continuous infusion (CI) or intravenous bolus patient-controlled sedation
      analgesia (PCSA) in patients under moderate level of sedation for vascular access procedures.
    

Intervention name(s): Comparison of pain intensity rating scale
Intervention type(s): Diagnostic Test
Intervention description(s): Comparison of numerical pain intensity rating scale Comparison of faces pain rating scale Comparison of consumption of total amount of remifentanil
Other intervention name(s): Sedation-Numerical pain intensity rating scale, Faces pain rating scale; Analgesia-Ramsey sedation scale; Drug-Remifentanil consumption of total amount of remifentanil
Intervention MeSH terms: Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a prospective, single-blinded randomized clinical study. The patients were divided into two groups with the method of one to one allocation and with the use of sealed envelope randomization.The first group was continuous infusion group (Group CI) and intravenous continuous remifentanil was infused after starting at a dosage of 0.1 µg/kg/min and the dose was raised incrementally up to 1µg/kg/min if required. The second group was intravenous bolus patient-controlled sedation analgesia (PCSA) and remifentanil infusion at a dose of 0.05 µg/kg, bolus of 0.1 μg/kg with lock-out time of three minutes was used. In both groups, a bolus dose of 0.1 µg/kg remifentanil was administered. The data evaluated include; level of pain and sedation, total amount of remifentanil consumption, bolus doses of remifentanil, use of a rescue medication, patient and surgeon satisfaction, hemodynamic data and adverse events.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment