Anesthesia for Vascular Access Devices

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

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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Satisfaction, Patient; Vascular Access Complication; Opioid Use, Unspecified; Sedation Complication; Remifentanil
• Intervention / Treatment: Diagnostic test: Comparison of pain intensity rating scale

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 Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Edirne, Turkey, 22030
    • Trakya University Faculty of Medicine Department of Anesthesiology
  • Istanbul, Turkey, 34846
    • Kartal Kosuyolu High Speciality Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous infusion of remifentanil; 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; Comparison of numerical pain intensity rating scale Comparison of faces pain rating scale Comparison of consumption of total amount of remifentanil; Other Names: Sedation-Numerical pain intensity rating scale, Faces pain rating scale; Analgesia-Ramsey sedation scale; Drug-Remifentanil consumption of total amount of remifentanil
Experimental: Patient-controlled sedoanalgesia (PCSA) of remifentanil; 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; Comparison of numerical pain intensity rating scale Comparison of faces pain rating scale Comparison of consumption of total amount of remifentanil; Other Names: Sedation-Numerical pain intensity rating scale, Faces pain rating scale; Analgesia-Ramsey sedation scale; Drug-Remifentanil consumption of total amount of remifentanil

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
• Collaborators: Trakya University Faculty of Medicine

Publications and helpful links

General Publications

• Vardon Bounes F, Pichon X, Ducos G, Ruiz J, Samier C, Silva S, Sommet A, Fourcade O, Conil JM, Minville V. Remifentanil for Procedural Sedation and Analgesia in Central Venous Catheter Insertion: A Randomized, Controlled Trial. Clin J Pain. 2019 Aug;35(8):691-695. doi: 10.1097/AJP.0000000000000725.
• Honarmand A, Safavi M, Nemati K, Oghab P. The efficacy of different doses of Midazolam added to Lidocaine for upper extremity Bier block on the sensory and motor block characteristics and postoperative pain. J Res Pharm Pract. 2015 Jul-Sep;4(3):160-6. doi: 10.4103/2279-042X.162359.
• Hinkelbein J, Lamperti M, Akeson J, Santos J, Costa J, De Robertis E, Longrois D, Novak-Jankovic V, Petrini F, Struys MMRF, Veyckemans F, Fuchs-Buder T, Fitzgerald R. European Society of Anaesthesiology and European Board of Anaesthesiology guidelines for procedural sedation and analgesia in adults. Eur J Anaesthesiol. 2018 Jan;35(1):6-24. doi: 10.1097/EJA.0000000000000683.
• Ryu JH, So YM, Hwang JW, Do SH. Optimal target concentration of remifentanil during cataract surgery with monitored anesthesia care. J Clin Anesth. 2010 Nov;22(7):533-7. doi: 10.1016/j.jclinane.2010.02.007.
• Sun GQ, Gao BF, Li GJ, Lei YL, Li J. Application of remifentanil for conscious sedation and analgesia in short-term ERCP and EST surgery. Medicine (Baltimore). 2017 Apr;96(16):e6567. doi: 10.1097/MD.0000000000006567.
• Chang DH, Hiss S, Herich L, Becker I, Mammadov K, Franke M, Mpotsaris A, Kleinert R, Persigehl T, Maintz D, Bangard C. Implantation of venous access devices under local anesthesia: patients' satisfaction with oral lorazepam. Patient Prefer Adherence. 2015 Jul 7;9:943-9. doi: 10.2147/PPA.S80330. eCollection 2015.
• Zanvettor A, Lederer W, Glodny B, Chemelli AP, Wiedermann FJ. Procedural sedation and analgesia for percutaneous trans-hepatic biliary drainage: Randomized clinical trial for comparison of two different concepts. Open Med (Wars). 2020 Aug 28;15(1):815-821. doi: 10.1515/med-2020-0220. eCollection 2020.
• Fanti L, Agostoni M, Gemma M, Gambino G, Facciorusso A, Guslandi M, Torri G, Testoni PA. Remifentanil vs. meperidine for patient-controlled analgesia during colonoscopy: a randomized double-blind trial. Am J Gastroenterol. 2009 May;104(5):1119-24. doi: 10.1038/ajg.2009.53. Epub 2009 Mar 31. Erratum In: Am J Gastroenterol. 2009 Jun;104(6):1613. Massimo, Agostoni [corrected to Agostoni, Massimo]; Marco, Gemma [corrected to Gemma, Marco]; Giulia, Gambino [corrected to Gambino, Giulia]; Antonio, Facciorusso [corrected to Facciorusso, Antonio]; Mario, Guslandi [corrected to Guslandi, Mario]; Giorgio,

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2012
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: February 4, 2021
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Remifentanil
• Other Study ID Numbers: 2012.3.35(#)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Purpose: The aim was to compare analgesic efficacy and adverse effects of two different techniques of intravenous remifentanil consumption in patients undergoing vascular access device procedures with monitored anesthesia care. The data evaluated include; level of pain and sedation, total amount of remifentanil consumption, bolus doses of remifentanil, patient and surgeon satisfaction, hemodynamic data and adverse events.
• IPD Sharing Time Frame: The data will become available after registration and will be available upon request from the Clinical Study Director at any time after registration.
• IPD Sharing Access Criteria: Study Protocol and Statistical Package for the Social Sciences computer program data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No