The Use of Midazolam and Remifentanil During Dialysis Access Procedures

Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Status: Completed

Conditions: Chronic Kidney Diseases; Adverse Reaction to Drug; Patient Satisfaction; Sedative Adverse Reaction; Midazolam Adverse Reaction; Arteriovenous Fistula; Analgesic Adverse Reaction

Treatments: Drug: Remifentanil intravenous bolus dose; Drug: Midazolam intravenous injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04226443

2013.1/28(#)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 patients

Sex: All

Ages: 43 to 81 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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99 participants in 2 patient groups

Group 1

Active Comparator group

Description:

In Group 1(n=50); continuous infusion of intravenous midazolam (Dormicum, Deva Pharmaceutical, Turkey) at a dose of 0.02 to 0.04 mg/kg/h was started at the beginning of the operation and the dose was adjusted depending on pain level and sedation level using appropriate scales for monitoring throughout the surgical time period. An intravenous bolus dose of midazolam at a dose of 0.015 mg/kg was administered before the start of the surgery. A rescue medication of intravenous bolus dose of remifentanil at a concentration of 5 μg/mL was used every 5 to 10 minutes in doses of 1 to 3 mL if necessary for pain scores greater than 3. The medications were stopped prior to the end of the surgery.

Treatment:

Drug: Midazolam intravenous injection

Drug: Remifentanil intravenous bolus dose

Group 2

Active Comparator group

Description:

in Group 2 (n=49), intravenous bolus doses of midazolam at a dose of 0.015 mg/kg every 10 minutes were administered at the beginning of the operation and the dose was adjusted depending on pain level and sedation level using appropriate scales for monitoring throughout the surgical time period. An intravenous bolus dose of midazolam at a dose of 0.015 mg/kg was administered before the start of the surgery. A rescue medication of intravenous bolus dose of remifentanil at a concentration of 5 μg/mL was used every 5 to 10 minutes in doses of 1 to 3 mL if necessary for pain scores greater than 3. The medications were stopped prior to the end of the surgery.

Treatment:

Drug: Midazolam intravenous injection

Drug: Remifentanil intravenous bolus dose