Skip to main content
OpenTrials
Completed

NCT Number: NCT04226443

The Use of Midazolam and Remifentanil During Dialysis Access Procedures

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sedative Adverse Reaction Adverse Reaction to Drug Agnosia Analgesic Adverse Reaction Arteriovenous Fistula Arteriovenous Malformations Behavior Cardiovascular Abnormalities Cardiovascular Diseases Chemically-Induced Disorders Chronic Disease Chronic Kidney Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Drug-Related Side Effects and Adverse Reactions Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fistula Health Behavior Kidney Diseases Male Urogenital Diseases Midazolam Adverse Reaction Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Patient Satisfaction Perceptual Disorders Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Treatment Adherence and Compliance Urogenital Diseases Urologic Diseases Vascular Diseases Vascular Fistula Vascular Malformations

Age range

43 year–81 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Midazolam intravenous injection

Drug

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.

Other names: Dormicum, Deva Pharmaceutical, Turkey

Remifentanil intravenous bolus dose

Drug

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.

Other names: Ultiva, Glaxo Smith Kline Pharmaceutical, England

Primary outcomes

  1. The amount of total use of midazolam and remifentanil drug consumptions in milligrams during operation time period.

    Time frame: Through the operative time period up to two hours of time.

    The comparison of total use of midazolam and remifentanil drug consumptions in milligrams during operation time period between the two groups.

  2. The evaluation of satisfaction of patient and surgeon by a questionnaire at the end of operation.

    Time frame: The collection of questionnaire at the end of operation in recovery room after recovery from sedation in a total of ten minutes time.

    The evaluation and comparison of satisfaction of patient and surgeon at the end of operation by a questionnaire between the two groups. Patient satisfaction level depending on the experience in general was 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 was evaluated at discharge from five point numerical scale: 0 = extremely poor; 1 = poor; 2 = fair; 3 = good; 4 = excellent.

  3. Modified Observer's Assessment of Alertness/Sedation Scale (MOSS/A) Scale

    Time frame: Through the operative time period up to two hours of time.

    The comparison of level of sedation using MOSS/A scale that ranges from 0 to 6, with a score of 6 defined as awake or minimally sedated, and a score of 0 defined as general anesthesia every 10 to 15 minutes between the two groups.

  4. Modified Observer's Assessment of Alertness/Sedation Scale (MOSS/A) Scale

    Time frame: Through the operative time period up to two hours of time.

    Repeated measure analysis of level of sedation by the use of the collected MOSS/A scale that ranges from 0 to 6, with a score of 6 defined as awake or minimally sedated, and a score of 0 defined as general anesthesia every 10 to 15 minutes within groups.

  5. Verbal Numerical Rating Scale

    Time frame: Through the operative time period up to two hours of time.

    The comparison of level of pain using Verbal Numerical Rating Scale (VNRS; 0= no pain, 10=the worst possible pain imaginable) scale every 10 to 15 minutes between the two groups.

  6. Verbal Numerical Rating Scale

    Time frame: Through the operative time period up to two hours of time.

    Repeated measure analysis of level of sedation by the use of the collected Verbal Numerical Rating Scale (VNRS; 0= no pain, 10=the worst possible pain imaginable) scale every 10 to 15 minutes between the two groups.

  7. Recovery time

    Time frame: Through the recovery room time period before discharge up to one hour time.

    The comparison of recovery time duration presented in minutes unit of time between the two groups.

  8. Hospital stay

    Time frame: Through the duration of stay in hospital before discharge up to seventy two hours time.

    The comparison of hospital stay duration presented in hours unit of time between the two groups.

  9. Systolic blood pressure values during operation and in the recovery room.

    Time frame: 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.

    The comparison of systolic blood pressure in mmHg unit values every 15 minutes between the two groups.

  10. Heart rate values during operation and in the recovery room.

    Time frame: 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.

    The comparison of heart rate values in beats per minute unit every fifteen minutes between the two groups.

  11. Pulse oximetry values during operation and in the recovery room.

    Time frame: 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.

    The comparison of pulse oximetry values in percent unit every fifteen minutes between the two groups.

  12. Adverse events during operation and in the recovery room.

    Time frame: 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.

    Number of Participants With Adverse Events as Assessed by CTCAE Version 4.03.

Sponsors and collaborators

Lead sponsor

Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Other Gov

Collaborators

  • Trakya University

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jan 13, 2020
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.