NCT04749069

Anesthesia for Vascular Access Devices

The Comparison of Two Different Techniques of Remifentanil Consumption During Implantable Vascular Access Device Procedures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital · Other Government
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid Use, Unspecified
• Remifentanil
• Sedation Complication
• Analgesia
• Satisfaction, Patient
• Vascular Access Complication

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Comparison of pain intensity rating scale	Comparison of numerical pain intensity rating scale Comparison of faces pain rating scale Comparison of consumption of total amount of remifentanil

Timeline

• Start date: 2012-08-01
• Primary completion: 2020-04-30
• Completion: 2020-06-30
• First posted: 2021-02-10
• Last updated: 2021-02-10

Locations

2 sites across 1 country: Turkey (Türkiye)