Anesthesia for Vascular Access Devices

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Diagnostic Test: Comparison of pain intensity rating scale


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 30-80 years old, American Society of Anesthesiologists Physical Status I to III, Referred for an venous access device implantation or removal procedure. Exclusion Criteria: morbid obesity (body mass index > 40), severe asthma, chronic obstructive lung disease, diabetes mellitus, hepatorenal disease, a history of opioid allergy, long-term opioid use or chronic pain, ASA PS ≥ 4, presence of epilepsy, acute cerebrovascular event, presence of hemodynamical instability such as peripheral oxygen saturation < 90%, systolic blood pressure < 60 mmHg and heart rate ≤ 40 bpm, patients complaining about intense pain before the procedure.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous infusion of remifentanil<br>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. | Diagnostic Test: Comparison of pain intensity rating scale<br>* Comparison of numerical pain intensity rating scale Comparison of faces pain rating scale Comparison of consumption of total amount of remifentanil<br>* Other names: Drug-Remifentanil consumption of total amount of remifentanil;|
| Experimental: Patient-controlled sedoanalgesia (PCSA) of remifentanil<br>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. | Diagnostic Test: Comparison of pain intensity rating scale<br>* Comparison of numerical pain intensity rating scale Comparison of faces pain rating scale Comparison of consumption of total amount of remifentanil<br>* Other names: Drug-Remifentanil consumption of total amount of remifentanil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Numeric Pain Intensity Rating Scale (NPRS) | During NPRS pain evaluation, a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain comparison and this includes 0 as no pain and 10 as the worst pain imaginable. There is a comparison of pain scale scores as a decrease of pain relief in an amount of 30% from the pain at start between the two groups. | After incision and during operative time every five minutes, through the operative time period up to two hours of time. | 
| The faces pain rating scale | The scale shows a series of faces ranging from a happy face at 0, or no hurt, to a crying face at 10, which represents hurts like the worst pain imaginable. | After incision and during operative time every five minutes, through the operative time period up to two hours of time. | 
| Measurement of sedation and analgesia | The comparison of the use of Ramsay Sedation Scale for measurement of sedation and analgesia between the two groups.The Ramsay Sedation Scale involves 6 levels and these include; 1- Patient is anxious and agitated or restless, or both, 2- Patient is co-operative, oriented, and tranquil, 3-Patient responds to commands only, 4- Patient exhibits brisk response to light glabellar tap or loud auditory stimulus, 5-Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus, 6- Patient exhibits no response. | After incision and during operative time every five minutes, through the operative time period up to two hours of time. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Remifentanil Consumption | The comparison of the use of total remifentanil consumption between the two groups. | At the end of operation, through the operative time period up to two hours of time. | 
| Modified Aldrete Score | The comparison of the use of Modified Aldrete scores in the recovery room before discharge between the two groups. | Through the recovery room time period before discharge up to one hour time. | 
| Duration of operation | The comparison of the duration of operations between the two groups. | At the end of operation, through the operative time period up to two hours of time. | 
| Incidence of adverse events and side effects. | The comparison of the incidence of adverse events and side effects between the two groups. | After operation in the recovery room through the recovery room time period before discharge up to one hour time and 24 hour after surgery. | 
| Patient and surgeon satisfaction | The comparison of satisfaction of patient and surgeon by a questionnaire at the end of operation between two groups. | The collection of questionnaire at the end of operation in recovery room after recovery from sedation in a total of ten minutes time. | 
| Recovery time | The comparison of recovery time between two groups. | Through the recovery room time period before discharge up to one hour time. | 
| Systolic blood pressure values during operation and in the recovery room. | The comparison of systolic blood pressure values during operation and in the recovery room between two groups. | 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 | 
| Diastolic blood pressure values during operation and in the recovery room. | The comparison of diastolic blood pressure values during operation and in the recovery room between two groups. | 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 | 
| Heart rate values during operation and in the recovery room. | The comparison of heart rate values during operation and in the recovery room between two groups. | 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. | 
| Pulse oximetry values during operation and in the recovery room. | The comparison of Pulse oximetry values during operation and in the recovery room between two groups. | 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 | 
| Hospital Stay | The comparison of hospital stay between two groups. | Through the duration of stay in hospital before discharge up to seventy two hours time. |