Clinical trial NCT04226443: The Use of Midazolam and Remifentanil During Dialysis Access Procedures
Official title: The Use of Midazolam and Remifentanil During Arteriovenous Fistula Placement Procedure and Monitored Anesthesia Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedative Adverse Reaction
Analgesic Adverse Reaction
Midazolam Adverse Reaction
Adverse Reaction to Drug
Patient Satisfaction
Chronic Kidney Diseases
Arteriovenous Fistula
Keywords: Midazolam
Remifentanil
Benzodiazepine
Opioid
Chronic Kidney Diseases
Analgesia
Sedation
Adverse Reaction
Patient Satisfaction
Arteriovenous Fistula
Lead sponsor: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Trakya University
First posted: 2020-01-13
Enrollment: 99
Sex: ALL
Minimum age (years): 43
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, randomized clinical study. The patients were divided into two groups with a 1: 1 allocation and sealed envelope randomization method. Both groups of patients received intravenous midazolam, in Group 1, intravenous midazolam was administered continuously whereas, in Group 2, intravenous midazolam was administered as intermittent bolus doses. Both groups received intravenous remifentanil bolus doses as a rescue medication.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age: Forty-three to eighty-one years of age,
2. ASA status: American Society of Anesthesiologist (ASA) status I-III,
3. The diagnosis: A diagnosis of chronic renal failure,
4. The operation type: An arteriovenous fistula procedure

Exclusion Criteria:

1. Body mass index greater than 40 that are considered morbidly obese patients,
2. Lung disorders leading to severe respiratory insufficiency such as; severe asthma, chronic obstructive lung disease,
3. Severe cardiovascular insufficiency or dysfunction,
4. Insulin-dependent diabetes mellitus,
5. Severe hepatic diseases,
6. ASA status of 4 and 5,
7. Neurologic disorders such as; the presence of epilepsy, arterial aneurysm, intracranial mass,
8. Patients complaining about intense pain before the procedure and patients with a history of long term opioid use or chronic pain,
9. Patients with a history of allergy to the study drugs,
10. Patients without written informed consent.

Primary outcomes:
measure: The amount of total use of midazolam and remifentanil drug consumptions in milligrams during operation time period.
timeFrame: Through the operative time period up to two hours of time.
measure: The evaluation of satisfaction of patient and surgeon by a questionnaire at the end of operation.
timeFrame: The collection of questionnaire at the end of operation in recovery room after recovery from sedation in a total of ten minutes time.
measure: Modified Observer's Assessment of Alertness/Sedation Scale (MOSS/A) Scale
timeFrame: Through the operative time period up to two hours of time.
measure: Modified Observer's Assessment of Alertness/Sedation Scale (MOSS/A) Scale
timeFrame: Through the operative time period up to two hours of time.
measure: Verbal Numerical Rating Scale
timeFrame: Through the operative time period up to two hours of time.
measure: Verbal Numerical Rating Scale
timeFrame: Through the operative time period up to two hours of time.
measure: Recovery time
timeFrame: Through the recovery room time period before discharge up to one hour time.
measure: Hospital stay
timeFrame: Through the duration of stay in hospital before discharge up to seventy two hours time.
measure: Systolic blood pressure values during operation and in the recovery room.
timeFrame: 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.
measure: Heart rate values during operation and in the recovery room.
timeFrame: 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.
measure: Pulse oximetry values during operation and in the recovery room.
timeFrame: 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.
measure: Adverse events during operation and in the recovery room.
timeFrame: 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 outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Trakya University, Faculty of Medicine, Edirne, Turkey
name: Gonul Sagiroglu, MD
role: STUDY_DIRECTOR
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