Anesthesia for Vascular Access Devices

NCT04749069 | Completed DMC

• 1 other identifier: 2012.3.35(#)
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• Total Remifentanil Consumption

  At the end of operation, through the operative time period up to two hours of time.

• Modified Aldrete Score

  Through the recovery room time period before discharge up to one hour time.

• Duration of operation

  At the end of operation, through the operative time period up to two hours of time.

• 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.

• 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.

Study Arms (2)

Continuous infusion of remifentanil

EXPERIMENTAL

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

Patient-controlled sedoanalgesia (PCSA) of remifentanil

EXPERIMENTAL

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

Interventions

Comparison of pain intensity rating scale DIAGNOSTIC_TEST

Comparison of numerical pain intensity rating scale Comparison of faces pain rating scale Comparison of consumption of total amount of remifentanil

Also known as: Sedation-Numerical pain intensity rating scale, Faces pain rating scale, Analgesia-Ramsey sedation scale, Drug-Remifentanil consumption of total amount of remifentanil

Continuous infusion of remifentanil; Patient-controlled sedoanalgesia (PCSA) of remifentanil

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old,
• American Society of Anesthesiologists Physical Status I to III,
• Referred for an venous access device implantation or removal procedure.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital: lead
• Trakya University: collaborator

Study Sites (2)

Trakya University Faculty of Medicine Department of Anesthesiology

Edirne, 22030, Turkey (Türkiye)

Location

Kartal Kosuyolu High Speciality Training and Research Hospital

Istanbul, 34846, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 26312256 BACKGROUND

• 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.

  PMID: 28877145 BACKGROUND

• 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.

  PMID: 21056810 BACKGROUND

• 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.

  PMID: 28422846 RESULT

• 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.

  PMID: 26185424 RESULT

• 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.

  PMID: 33336039 RESULT

• 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.

  PMID: 19337241 RESULT

• 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.

  PMID: 31094935 RESULT

MeSH Terms

Conditions

Agnosia; Patient Satisfaction

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In our study, random allocation sequence was performed using a computer programme for each patient to prevent bias. For concealed allocation, patients were randomly allocated into one group using a numbered, opaque and sealed envelope. A randomized block design is as follows: code A was given to the first group, and code B was given to the second group. The participant, data collector and data analyzer were blinded. This study was a single-blinded controlled study because the sedation and analgesia were administered by anesthesiology residents who were unaware of the technique and the study protocol however, the protocol was known by the experienced anesthesiologist who was attending the case and collecting the data during the procedure. The preparation of remifentanil solutions and installation of the infusion devices were done by an anesthesiologist who was blinded for the study groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The comparison of patient-controlled sedation method and anesthesiologist-controlled sedation method in port interventions

Model Details: 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.

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 10, 2021
• Study Start: August 1, 2012
• Primary Completion: April 30, 2020
• Study Completion: June 30, 2020
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• Access Criteria: Study Protocol and Statistical Package for the Social Sciences computer program data.

Locations

TU (2)