Anesthesia for Vascular Access Devices

Status Completed

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04749069
Study type	Interventional
Source	Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Contact
Status	Completed
Phase	N/A
Start date	August 1, 2012
Completion date	June 30, 2020

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT05534230` - Dexmedetomidine for Pain Reduction in CABG	N/A
Recruiting	`NCT06275698` - HONEY for the Treatment of POst-Tonsillectomy Pain	N/A
Recruiting	`NCT04436224` - Hydromorphone for ICU-analgesia in Patients With Non-mechanical Ventilation	Phase 4
Not yet recruiting	`NCT04548323` - Hypoalgesic Effects of Walking and Running Imagined
Completed	`NCT06054945` - Clinical Impact of IPACK Block Addition to Suprainguinal Fascia Iliaca Block
Completed	`NCT04394481` - Extension of Analgesia by Combined Injection of Dexamethasone and Dexmedetomidine After Arthroscopic Shoulder Surgery	Phase 4
Completed	`NCT04690647` - The Efficacy of Suprainguinal Fascia Iliaca Compartment Block for Analgesia After Elective Total Hip Replacement.	N/A
Completed	`NCT05034601` - ESPB vs TPVB for Postoperative Analgesia After the Nuss Procedure	N/A
Completed	`NCT03740815` - Feasibility of Serratus Plane Block Associated With Sedation in Axillary Dissection	N/A
Recruiting	`NCT05454202` - Assessment of the Interest of ANI in the Non-communicating Patient in Palliative Care
Recruiting	`NCT04554186` - Serratus Anterior Plane Block Versus Thoracic Paravertebral Block.	N/A
Suspended	`NCT04860635` - Safety of F14 Following Total Knee Replacement	Phase 2/Phase 3
Not yet recruiting	`NCT06393777` - Effectiveness of Pre-administered Natural Sweet-tasting Solution (Honey) for Decreasing Pain of Needle Insertion	N/A
Not yet recruiting	`NCT04519463` - The Effect of Local Anesthesia With Lidocaine During Insertion and Removal of Nasal Packing	Early Phase 1
Completed	`NCT02916342` - Interscalene Block Versus Combined Supraprascapular: Axillary Nerve Blocks	Phase 4
Completed	`NCT03206554` - Local Infiltration Analgesia in Total Knee Arthroplasty	Phase 2
Not yet recruiting	`NCT02549118` - Tenoxicam for Intrapartum Analgesia	Phase 2
Not yet recruiting	`NCT02190760` - Comparison Between Perineural and Systemic Effect of Dexamethasone for Interscalene Brachial Plexus Block.	N/A
Completed	`NCT01789606` - Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet	Phase 3
Completed	`NCT01299584` - ULTIVA Post Marketing Surveillance	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.