Anesthesia for Vascular Access Devices

Not Applicable

Completed

• Conditions: Sedation Complication; Satisfaction, Patient; Remifentanil; Analgesia; Vascular Access Complication; Opioid Use, Unspecified
• Interventions: Diagnostic Test: Comparison of pain intensity rating scale

• Registration Number: NCT04749069
• Lead Sponsor: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

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.

Study Timeline

• Study Start: 2012-08-01
• Primary Completion: 2020-04-30
• Study Completion: 2020-06-30
• Status Verified: 2021-02
• Study First Submitted: 2021-02-04
• Study First Submitted QC: 2021-02-09
• Last Update Submitted: 2021-02-09
• Study First Posted: 2021-02-10
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous infusion of remifentanil	Comparison of pain intensity rating scale	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.
Patient-controlled sedoanalgesia (PCSA) of remifentanil	Comparison of pain intensity rating scale	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.

Primary Outcome Measures

Name	Time	Method
The Numeric Pain Intensity Rating Scale (NPRS)	After incision and during operative time every five minutes, through the operative time period up to two hours of time.	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.
The faces pain rating scale	After incision and during operative time every five minutes, through the operative time period up to two hours of time.	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".
Measurement of sedation and analgesia	After incision and during operative time every five minutes, through the operative time period up to two hours of time.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Trakya University Faculty of Medicine Department of Anesthesiology; 🇹🇷 Edirne, Turkey

Kartal Kosuyolu High Speciality Training and Research Hospital; 🇹🇷 Istanbul, Turkey