CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 99 enrolled
Drug / intervention
Midazolam intravenous injection +1 moredrug
Likely dose
Midazolam intravenous injection 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04226443
NCT04226443N/ACompleted

The Use of Midazolam and Remifentanil During Arteriovenous Fistula Placement Procedure and Monitored Anesthesia Care

Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital·interventional·Posted Jan 13, 2020·Updated Jan 13, 2020

In Brief

A clinical study evaluating Midazolam intravenous injection and Remifentanil intravenous bolus dose for Sedative Adverse Reaction and 6 related conditions. Completed, enrolled 99 participants.

Detailed Summary

BACKGROUND: Sedation and analgesia are related to unexpected adverse events in chronic renal failure patients undergoing arteriovenous fistula placement procedures under monitored anesthesia care (MAC). OBJECTIVE: Our goal was to investigate and compare the sedation and analgesia related effects and adverse effects of continuous intravenous use of midazolam and intermittent bolus doses of midazolam while intravenous remifentanil is used as a rescue medication in patients with chronic renal failure.

Study Details

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 13, 2020
Enrollment StartAug 28, 2012
Primary CompletionApr 15, 2016
Study CompletionApr 30, 2016
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 6.5 years ago

Interventions

Midazolam intravenous injectiondrug

The midazolam was prepared as 5 mg midazolam in 20 mL syringe of 5% dextrose water solution (0.25 mg/mL) in both arms. Both groups of patients received an intravenous bolus dose of midazolam was administered before the start of the surgery. In Group 1, continuous infusion of intravenous midazolam was started and in Group 2, intravenous bolus doses of midazolam were administered. The doses were adjusted depending on pain level and sedation level using appropriate scales for monitoring during the surgical time period. The drip rate was adjusted according to pain intensity. The infusion of drugs was discontinued at the end of the procedure.

Remifentanil intravenous bolus dosedrug

A remifentanil infusion was prepared as follows; 0.5 mg remifentanil was added into 100 mL of 0.9% saline at a concentration of 5 μg/mL. The preparation of remifentanil solution and installation of the device was done by an anesthesiologist who was blinded for the study groups. The dose and number of patients that required remifentanil were recorded. The infusion of drugs was discontinued at the end of the procedure. A rescue medication of intravenous remifentanil bolus dose was used as 1 to 3 mL (5 μg or 15 μg) every 5 minutes if necessary for pain scores greater than 3. This infusion was prepared prior to the use during the study and was discontinued at the end of the procedure.