Anesthesia for Vascular Access Devices

Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Status: Completed

Conditions: Vascular Access Complication; Sedation Complication; Remifentanil; Analgesia; Opioid Use, Unspecified; Satisfaction, Patient

Treatments: Diagnostic Test: Comparison of pain intensity rating scale

Study type: Interventional

Funder types: Other

Identifiers

NCT04749069

2012.3.35(#)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 107 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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107 participants in 2 patient groups

Continuous infusion of remifentanil

Experimental group

Description:

In continuous infusion group of patients, remifentanil was infused at a dose of 0.1 µg/kg/min and the additional bolus dose of 0.1 µg/kg was given if required. Before start of the operation, in both groups of patients, intravenous remifentanil at a bolus dose of 0.1 µg/kg was administered slowly in a duration of 60 seconds.

Treatment:

Diagnostic Test: Comparison of pain intensity rating scale

Patient-controlled sedoanalgesia (PCSA) of remifentanil

Experimental group

Description:

In PCSA group of patients, remifentanil was given by bolus PCSA using a pump (Pain Management Provider, Abbott Laboratories and Eczacibasi-Baxter, Ireland). In PCSA group of patients, remifentanil infusion was at a dose of 0.05 µg/kg, a bolus dose of 0.1 μg/kg with a lock-out time of three minutes.

Treatment:

Diagnostic Test: Comparison of pain intensity rating scale