Chronic Kidney Diseases Clinical Trial
Official title:
The Use of Midazolam and Remifentanil During Arteriovenous Fistula Placement Procedure and Monitored Anesthesia Care
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.
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 to intermittent bolus doses of
midazolam while intravenous remifentanil is used as a rescue medication in patients with
chronic renal failure.
DESIGN: From a total of 116 patients, 99 patients with chronic renal failure undergoing
arteriovenous fistula procedures were included in a prospective randomized study.
SETTINGS: Two tertiary care hospitals. PATIENTS: The patients were divided into Group 1
(continuous)(n=50); patients receiving intravenous midazolam infusion at a dose of 0.02 to
0.04 mg/kg/h and Group 2 (intermittent)(n=49); patients receiving intermittent intravenous
bolus doses of 0.015 mg/kg every 10 minutes.
MAIN OUTCOME MEASURES: Primary outcomes were; 1- The total amount of doses of the use of
midazolam and remifentanil in both groups of patients, 2- The evaluation of satisfaction of
patient and surgeon at the end of the operation, in the recovery room during the period of
recovery from sedation and before discharge. Other outcome measures include; the sedative,
analgesic and hemodynamical effects of sedative medications that were compared in both groups
of patients during the operation time period. The hospital stay duration was recorded and
compared between groups. The maximum dose of midazolam was limited to 4 mg intravenously. The
intensity of pain was assessed using a verbal numerical sedation scale (range 1 to 10) (VNRS)
and the sedation level was recorded by Modified Observer's Assessment of Alertness/Sedation
Scale (MOSS/A) (range 0 to 6). MOSS/A Scale includes; Score 0: Does not respond to deep
stimulus, Score 1: Does not respond to mild prodding or shaking, Score 2: Responds only after
mild prodding or shaking, Score 3: Responds only after name is called loudly and/or
repeatedly, Score 4: Lethargic response to name spoken in normal tone, Score 5: Responds
readily to name spoken in normal tone, Score 6: Agitated. An intravenous bolus dose of
remifentanil as a rescue medication was administered for pain scores greater than 3 at a dose
of 5µg/mL. Adverse events were recorded. Patient satisfaction level depending on the
experience in general were evaluated at discharge from 0 to 4 point numerical scale: 0 =
extremely dissatisfied; 1 = dissatisfied; 2 = neither satisfied nor dissatisfied; 3 =
satisfied; 4 = extremely satisfied. Surgeon satisfaction level depending on the experience in
general were evaluated at discharge from five-point numerical scale: 0 = extremely poor; 1 =
poor; 2 = fair; 3 = good; 4 = excellent.
SAMPLE SIZE: The sample size was calculated based on a power of 80% and a 5% type-I error and
for each group, thirty patients were required.
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