The Use of Midazolam and Remifentanil During Dialysis Access Procedures

Chronic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04226443
• Other study ID #: 2013.1/28(#)
• Status: Completed
• Phase: N/A
• Start date: August 28, 2012
• Est. completion date: April 30, 2016

Study information

• Verified date: January 2020
• Source: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: April 30, 2016
• Est. primary completion date: April 15, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 43 Years to 81 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adverse Reaction to Drug
• Analgesic Adverse Reaction
• Arteriovenous Fistula
• Chronic Kidney Diseases
• Drug-Related Side Effects and Adverse Reactions
• Fistula
• Kidney Diseases
• Midazolam Adverse Reaction
• Patient Satisfaction
• Renal Insufficiency, Chronic
• Sedative Adverse Reaction

Intervention

Drug:
• Midazolam intravenous injection
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 dose
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital	Trakya University

References & Publications (12)

Ahuja V, Mitra S, Kazal S, Huria A. Comparison of analgesic efficacy of flupirtine maleate and ibuprofen in gynaecological ambulatory surgeries: A randomized controlled trial. Indian J Anaesth. 2015 Jul;59(7):411-5. doi: 10.4103/0019-5049.160937. — View Citation

Beathard GA, Urbanes A, Litchfield T, Weinstein A. The risk of sedation/analgesia in hemodialysis patients undergoing interventional procedures. Semin Dial. 2011 Jan-Feb;24(1):97-103. doi: 10.1111/j.1525-139X.2011.00844.x. — View Citation

Boonstra AM, Stewart RE, Köke AJ, Oosterwijk RF, Swaan JL, Schreurs KM, Schiphorst Preuper HR. Cut-Off Points for Mild, Moderate, and Severe Pain on the Numeric Rating Scale for Pain in Patients with Chronic Musculoskeletal Pain: Variability and Influence — View Citation

Cole NM, Vlassakov K, Brovman EY, Heydarpour M, Urman RD. Regional Anesthesia for Arteriovenous Fistula Surgery May Reduce Hospital Length of Stay and Reoperation Rates. Vasc Endovascular Surg. 2018 Aug;52(6):418-426. doi: 10.1177/1538574418772451. Epub 2018 Apr 29. — View Citation

Coyle TT, Helfrick JF, Gonzalez ML, Andresen RV, Perrott DH. Office-based ambulatory anesthesia: Factors that influence patient satisfaction or dissatisfaction with deep sedation/general anesthesia. J Oral Maxillofac Surg. 2005 Feb;63(2):163-72. — View Citation

Hatzidakis AA, Charonitakis E, Athanasiou A, Tsetis D, Chlouverakis G, Papamastorakis G, Roussopoulou G, Gourtsoyiannis NC. Sedations and analgesia in patients undergoing percutaneous transhepatic biliary drainage. Clin Radiol. 2003 Feb;58(2):121-7. — View Citation

Levey AS, Eckardt KU, Tsukamoto Y, Levin A, Coresh J, Rossert J, De Zeeuw D, Hostetter TH, Lameire N, Eknoyan G. Definition and classification of chronic kidney disease: a position statement from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int. 2005 Jun;67(6):2089-100. — View Citation

Niscola P, Scaramucci L, Vischini G, Giovannini M, Ferrannini M, Massa P, Tatangelo P, Galletti M, Palumbo R. The use of major analgesics in patients with renal dysfunction. Curr Drug Targets. 2010 Jun;11(6):752-8. Review. — View Citation

Sá Rêgo MM, Inagaki Y, White PF. Remifentanil administration during monitored anesthesia care: are intermittent boluses an effective alternative to a continuous infusion? Anesth Analg. 1999 Mar;88(3):518-22. — View Citation

Son A, Mannoia K, Herrera A, Chizari M, Hagdoost M, Molkara A. Dialysis Access Surgery: Does Anesthesia Type Affect Maturation and Complication Rates? Ann Vasc Surg. 2016 May;33:116-9. doi: 10.1016/j.avsg.2015.12.005. Epub 2016 Mar 8. — View Citation

Sun GQ, Gao BF, Li GJ, Lei YL, Li J. Application of remifentanil for conscious sedation and analgesia in short-term ERCP and EST surgery. Medicine (Baltimore). 2017 Apr;96(16):e6567. doi: 10.1097/MD.0000000000006567. — View Citation

Wyne A, Rai R, Cuerden M, Clark WF, Suri RS. Opioid and benzodiazepine use in end-stage renal disease: a systematic review. Clin J Am Soc Nephrol. 2011 Feb;6(2):326-33. doi: 10.2215/CJN.04770610. Epub 2010 Nov 11. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The amount of total use of midazolam and remifentanil drug consumptions in milligrams during operation time period.	The comparison of total use of midazolam and remifentanil drug consumptions in milligrams during operation time period between the two groups.	Through the operative time period up to two hours of time.
Primary	The evaluation of satisfaction of patient and surgeon by a questionnaire at the end of operation.	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.	The collection of questionnaire at the end of operation in recovery room after recovery from sedation in a total of ten minutes time.
Primary	Modified Observer's Assessment of Alertness/Sedation Scale (MOSS/A) Scale	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.	Through the operative time period up to two hours of time.
Primary	Modified Observer's Assessment of Alertness/Sedation Scale (MOSS/A) Scale	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.	Through the operative time period up to two hours of time.
Primary	Verbal Numerical Rating Scale	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.	Through the operative time period up to two hours of time.
Primary	Verbal Numerical Rating Scale	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.	Through the operative time period up to two hours of time.
Primary	Recovery time	The comparison of recovery time duration presented in minutes unit of time between the two groups.	Through the recovery room time period before discharge up to one hour time.
Primary	Hospital stay	The comparison of hospital stay duration presented in hours unit of time between the two groups.	Through the duration of stay in hospital before discharge up to seventy two hours time.
Primary	Systolic blood pressure values during operation and in the recovery room.	The comparison of systolic blood pressure in mmHg unit values every 15 minutes between the two groups.	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.
Primary	Heart rate values during operation and in the recovery room.	The comparison of heart rate values in beats per minute unit every fifteen minutes between the two groups.	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.
Primary	Pulse oximetry values during operation and in the recovery room.	The comparison of pulse oximetry values in percent unit every fifteen minutes between the two groups.	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.
Primary	Adverse events during operation and in the recovery room.	Number of Participants With Adverse Events as Assessed by CTCAE Version 4.03.	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.