Anesthesia for Vascular Access Devices

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04749069
• Other study ID #: 2012.3.35(#)
• Status: Completed
• Phase: N/A
• Start date: August 1, 2012
• Est. completion date: June 30, 2020

Study information

• Verified date: February 2021
• Source: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: June 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Turkey	Trakya University Faculty of Medicine Department of Anesthesiology	Edirne
Turkey	Kartal Kosuyolu High Speciality Training and Research Hospital	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital	Trakya University Faculty of Medicine

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

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 — View Citation

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 — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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) — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Recovery time	The comparison of recovery time between two groups.	Through the recovery room time period before discharge up to one hour time.
Secondary	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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.