Clinical trial NCT04749069: Anesthesia for Vascular Access Devices
Official title: The Comparison of Two Different Techniques of Remifentanil Consumption During Implantable Vascular Access Device Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use, Unspecified
Remifentanil
Sedation Complication
Analgesia
Satisfaction, Patient
Vascular Access Complication
Lead sponsor: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Trakya University Faculty of Medicine
First posted: 2021-02-10
Enrollment: 107
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. 30-80 years old,
2. American Society of Anesthesiologists Physical Status I to III,
3. Referred for an venous access device implantation or removal procedure.

Exclusion Criteria:

1. morbid obesity (body mass index \> 40),
2. severe asthma, chronic obstructive lung disease, diabetes mellitus, hepatorenal disease,
3. a history of opioid allergy,
4. long-term opioid use or chronic pain,
5. ASA PS ≥ 4,
6. presence of epilepsy,
7. acute cerebrovascular event,
8. presence of hemodynamical instability such as peripheral oxygen saturation \< 90%, systolic blood pressure \< 60 mmHg and heart rate ≤ 40 bpm,
9. patients complaining about intense pain before the procedure.

Primary outcomes:
measure: The Numeric Pain Intensity Rating Scale (NPRS)
timeFrame: After incision and during operative time every five minutes, through the operative time period up to two hours of time.
measure: The faces pain rating scale
timeFrame: After incision and during operative time every five minutes, through the operative time period up to two hours of time.
measure: Measurement of sedation and analgesia
timeFrame: After incision and during operative time every five minutes, through the operative time period up to two hours of time.
Secondary outcomes:
measure: Total Remifentanil Consumption
timeFrame: At the end of operation, through the operative time period up to two hours of time.
measure: Modified Aldrete Score
timeFrame: Through the recovery room time period before discharge up to one hour time.
measure: Duration of operation
timeFrame: At the end of operation, through the operative time period up to two hours of time.
measure: Incidence of adverse events and side effects.
timeFrame: After operation in the recovery room through the recovery room time period before discharge up to one hour time and 24 hour after surgery.
measure: Patient and surgeon satisfaction
timeFrame: The collection of questionnaire at the end of operation in recovery room after recovery from sedation in a total of ten minutes time.
measure: Recovery time
timeFrame: Through the recovery room time period before discharge up to one hour time.
measure: Systolic blood pressure values during operation and in the recovery room.
timeFrame: The collection of systolic blood pressure in mmHg unit values every 15 minutes through the operative time period up to two hours of time and through the recovery room time period before discharge up to one hour time
measure: Diastolic blood pressure values during operation and in the recovery room.
timeFrame: The collection of diastolic blood pressure in mmHg unit values every 15 minutes through the operative time period up to two hours of time and through the recovery room time period before discharge up to one hour time
measure: Heart rate values during operation and in the recovery room.
timeFrame: Through the operative time period up to two hours of time and through the recovery room time period before discharge up to one hour time.
measure: Pulse oximetry values during operation and in the recovery room.
timeFrame: hrough the operative time period up to two hours of time and through the recovery room time period before discharge up to one hour time
measure: Hospital Stay
timeFrame: Through the duration of stay in hospital before discharge up to seventy two hours time.
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Trakya University Faculty of Medicine Department of Anesthesiology
city: Istanbul
country: Turkey
facility: Kartal Kosuyolu High Speciality Training and Research Hospital
Study officials:
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