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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
Comparison of numerical pain intensity rating scale Comparison of faces pain rating scale Comparison of consumption of total amount of remifentanil
Trakya University Faculty of Medicine Department of Anesthesiology
Edirne, Turkey (Türkiye)
Kartal Kosuyolu High Speciality Training and Research Hospital
Istanbul, Turkey (Türkiye)
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.
Time frame: 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".
Time frame: 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.
Time frame: After incision and during operative time every five minutes, through the operative time period up to two hours of time.
Total Remifentanil Consumption
The comparison of the use of total remifentanil consumption between the two groups.
Time frame: At the end of operation, through the operative time period up to two hours of time.
Modified Aldrete Score
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
DOUBLE
Enrollment
107
The comparison of the use of Modified Aldrete scores in the recovery room before discharge between the two groups.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through the duration of stay in hospital before discharge up to seventy two hours time.