|Year : 2022 | Volume
| Issue : 3 | Page : 66-70
A clinical trial of comparing dexmedetomidine and remifentanil on the oximetry parameters in the patients with end-stage renal disease undergoing arteriovenous fistula formation
Reza Mahmoud Mohaghegh Dolatabadi1, Soudabeh Djalali Motlagh2, Mohamadreza Ghodraty2, Amineh Shafeinia3, Alireza Maleki4, Zeinab Norouzi5, Shiva Khaleghparast6
1 Department of Anesthesiology, Hasheminejad Hospital, Iran University of Medical Sciences, Tehran, Iran
2 Department of Anesthesiology, Firoozgar General Hospital, Iran University of Medical Sciences, Tehran, Iran
3 Department of Anesthesiology, Akbarabadi Hospital, Iran University of Medical Sciences, Tehran, Iran
4 Department of Anesthesiology, Rasoul Akram Hospital, Iran University of Medical Sciences, Tehran, Iran
5 Department of Cardiac Rehabilitation, Rajaie Cardiovascular and Research Center, Tehran, Iran
6 Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran
|Date of Submission||19-Feb-2022|
|Date of Decision||06-Jun-2022|
|Date of Acceptance||07-Jun-2022|
|Date of Web Publication||11-Oct-2022|
Dr. Alireza Maleki
Department of Anesthesiology, Rasoul Akram Hospital, Iran University of Medical Sciences, Tehran
Source of Support: None, Conflict of Interest: None
Background: Oximetry is a method for measuring the arterial hemoglobin saturation (SpO2) using pulse oximeter and is essential in any type of anesthetic procedures. The growing population of geriatrics in the recent decades in combination with an increase in the prevalence of chronic diseases including diabetes and hypertension are some of the leading causes for an increase in the prevalence of chronic kidney disease and end-stage renal disease (ESRD). The definite treatment for ESRD is renal transplant but unfortunately, it may take a long time to find a suitable kidney and continuing the patient's life may depend on dialysis. Arteriovenous fistula (AVF) formation is one of the first steps to prepare the patient for hemodialysis. ESRD itself is a reason for physical and psychosocial issues. Preparing a favorable condition for AVF surgery is essential to decrease the burden of the underlying disease. An efficient respiratory supply is necessary in all parts of an anesthetic procedures. Aims and Objectives: This study is a double-blind clinical trial to compare two anesthetic agents, dexmedetomidine and remifentanil in patients with ESRD who underwent AVF formation. Materials and Methods: SpO2 was measured on different phases including the time of initial incision, and after 10, 30, 60, 90, and 120 min of finishing the surgery. The data were analyzed using SPSS version 22, two-way repeated measures (ANOVA), and independent t-test. Results: This study showed that there was no any significant difference in using any of these two agents with regard to SpO2 in the different times of measurements during the anesthetic procedure and after the surgery in the recovery phase. Conclusion: This study showed that there is not any superiority in using DEX or REM in the patients undergo AVF formation. More studies on the other groups of the patients with different surgeries.
Keywords: Arteriovenous fistula, dexmedetomidine, end-stage renal disease, oximetry, remifentanil
|How to cite this article:|
Dolatabadi RM, Motlagh SD, Ghodraty M, Shafeinia A, Maleki A, Norouzi Z, Khaleghparast S. A clinical trial of comparing dexmedetomidine and remifentanil on the oximetry parameters in the patients with end-stage renal disease undergoing arteriovenous fistula formation. Res Cardiovasc Med 2022;11:66-70
|How to cite this URL:|
Dolatabadi RM, Motlagh SD, Ghodraty M, Shafeinia A, Maleki A, Norouzi Z, Khaleghparast S. A clinical trial of comparing dexmedetomidine and remifentanil on the oximetry parameters in the patients with end-stage renal disease undergoing arteriovenous fistula formation. Res Cardiovasc Med [serial online] 2022 [cited 2022 Nov 28];11:66-70. Available from: https://www.rcvmonline.com/text.asp?2022/11/3/66/358228
| Introduction|| |
Oximetry is used for evaluating the blood oxygen status and pulse oximeter is a noninvasive tool for measuring the blood oxygen saturation., The basic function of the pulse oximeter is a spectrometry for quantification of arterial hemoglobin saturation (SpO2).,,,, Pulse oximetry is one of the essential parts for the patients' care in anesthesia. The first pulse oximeter was created in 1935 by Matthes for evaluating the blood oxygen constantly, and after developing the first version by the other researchers, it was used in the operating room by Earl Wood in the late 1940s for the first time. It was used by Glenn Allen Millikan during world War II to evaluate the piolets' O2 saturation (SaO2) during the flightes. Then, the scientists found that the clinical presentations of patients with cyanosis are not reliable due to severe anemia or skin pigmentation. Furthermore, the symptoms of hypoxia are detected when the SaO2 is lower than 80%. Pulse oximetry is a useful measurement for the early diagnosis of cyanosis. In 1974, Aoyagi et al. made a type of pulse oximeter with the combination of photoplethysmography and oximetry in a single tool. Since the early years of the 1980 decade, pulse oximetry was widely used in the clinical fields. According to the recommendations of the American Society of Anesthesiologists, pulse oximetry is a part of basic standard care in the operating room. Pulse oximetry is perhaps the most important measurement tool to show valuable data including heart rate and SaO2. It is used to evaluate the peripheral oxygen supply and is indicated in all of the patients, especially in the geriatrics. According to the aging of the population, the prevalence of chronic diseases is increasing. Chronic kidney disease (CKD) is not only a consequence of aging but also is a complication of other chronic diseases including hypertension and diabetes mellitus., Furthermore, with increasing in the elderly population in the world, increasing the prevalence of CKD is not surprising. The definite treatment for end-stage renal disease (ESRD) is kidney transplant, but it is not available for a huge population of patients for a long time, and continuing the life in these patients is dependent to dialysis., Arteriovenous fistula (AVF) formation is the first step of hemodialysis in ESRD patients and physical and psychological problems may happen in most of these patients.,, A favorable anesthesia can reduce the mentioned burden in the patients significantly and using appropriate agents plays an important role to achieve to this purpose. Dexmedetomidine (DEX) is a selective agonist of the α-2 adrenoceptor without the effect of respiratory depression. Remifentanil (REM) is an agonist of μ-opioid receptor and is known as an approximately safe agent for patients with CKD.
In this study, the effect of the two anesthetic agents including DEX and REM on the oximetry parameters is compared to each other in the patients with ESRD who underwent AVF formation.
| Methods|| |
It is a double-blind clinical trial. In this study based on the formula, 40 patients with ESRD were enrolled. The inclusion criteria were being a candidate for AVF formation, the age of 19–80 years old and being in a stable hemodynamic on the admission. The exclusion criteria were the positive history for the chronic diseases including cardiovascular diseases, hepatic failure, history of allergic reaction to any of the anesthetic agents, especially opioids, the history of the recent respiratory infections or severe bronchopulmonary diseases, pregnancy, or breastfeeding.
The patients participated freely in the study and with a complete awareness about the study and also, the documented agreements were collected from the participants. This study was under the approval of the Iran University of Medical Sciences (IUMS) with the code of IR. IUMS.FMD.REC.1399.115 and was recorded in the clinical trial system with the ID of IRCT20200502047269N1. First, demographic data including age, gender, history of diabetes, hypertension, and addiction were recorded. Then, vital signs of the patients were evaluated. All of the patients were candidates for AVF formation and they were stable hemodynamically to minimize the effects of confounding factors on study results of the anesthesiological study. Furthermore, the monitoring of vital signs was continued during the anesthesiological procedures. Before starting the surgery, routine monitoring was done including pulse rate, electrocardiogram, noninvasive blood pressure monitoring, and SPO2. Then, the patients were divided into two groups and the blind sequencing of the patients was done using the website: https://www.sealedenvelope.com/simple-randomiser/v1/lists.
At the beginning of the procedure, 100 mg of subcutaneous lidocaine was injected for all of the patients. For the first group, DEX (intravenous bolus dose of 1 μg/kg in 10 min and the maintenance dose of 0.5 μg/kg/h) and for the second group REM (Intravenous bolus dose of 1 μg/kg in 10 min and the maintenance dose of 0.2 μg/kg/min) were injected. The SpO2 was measured when the initial incision was made and then after 10 min, 30, 60, 90, and 120 min after finishing the surgery in the recovery phase was also evaluated [Figure 1]. The data were analyzed using SPSS version 22, two-way repeated measures (ANOVA), and independent t-test.
|Figure 1: The flow diagram of the study. ESRD: End stage renal disease, SpO2: Arterial hemoglobin saturation, PR: Pulse rate, NIBP: Noninvasive blood pressure monitoring, ECG: Electrocardiogram, DEX: Dexmedetomidine, REM: Remifentanil, AVF: Arteriovenous fistula|
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| Results|| |
In this study, 40 patients were participated. The mean age in the DEX and the REM groups were 57.95 ± 10.86 and 59.5 ± 10.45 years old, respectively, and there was no any significant difference between these two groups (P = 0.648). In the DEX group, 70% of the patients were male and 30% were female. In addition, in the REM group, 55% of the patients were male and 45% were female and the difference between the two groups was not statistically significant (P = 0.327). The history of hypertension in the DEX and RME groups was 80% and 85%, respectively (P = 1.00). Furthermore, 60% of the patients in the DEX group were diabetic, and it was 45% in the REM group. Furthermore, the difference was not statistically significant (P = 0.342). In addition, the rate of addiction was close to each other in both groups and it was 10% and 15% in the DEX and REM groups, respectively (P = 0.633). Body mass index in the DEX and REM groups were 26.7 ± 3.42 kg/m2 and 25.15 ± 2.61 kg/m2, respectively, with no statistically significant difference (P = 0.115) [Table 1].
The comparison of SpO2 in the dexmedetomidine and remifentanil groups
For evaluation of SpO2, the measurement was done using pulse oximeter several times during and after the surgery. SpO2 on the beginning of the surgery and just after the surgical incision, was 97.95 ± 1.50 in the DEX and 98.10 ± 1.48 in the REM group (P = 0.589). SpO2 assessment was continued during the surgery in different times including 10 min after starting the surgery and 30, 60, 90, and 120 min after the surgery in the recovery phase. 10 min after the beginning of the surgery, SpO2 was 97.85 ± 1.23 in the DEX group and 97.85 ± 0.88 in the REM group (P = 0.884). Thirty minutes after the surgery in the recovery phase, SpO2 in the DEX and the REM groups were 97.95 ± 1.15 and 97.60 ± 1.14, respectively (P = 0.340). 60 min after the surgery SpO2 in the DEX and the REM groups were 98.15 ± 1.09 and 98.05 ± 0.89, respectively (P = 0.876). After 90 min, SpO2 in the DEX and the REM groups were 98.15 ± 1.14 and 98.05 ± 1.23, respectively (P = 0.693). Finally, 120 min after the surgery Spo2 was 98.10 ± 1.17 in the DEX and 98.25 ± 1.12 in the REM groups (P = 0.680). Overall, no statistically significant difference was found with regard to SpO2 while using DEX or REM in the different times of assessment [Table 2] and [Figure 2].
|Figure 2: The diagram for comparing the mean and standard deviation of Spo2 on the beginning of the surgery, during and after the surgery in the frequent times of evaluation in the two groups|
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|Table 2: The variability of oxygen saturation in two groups of the study|
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The result of the two-way repeated measure ANOVA showed that the difference in SpO2 in the two groups was not statistically significant (F = 0.032, df = 1, P = 0.859), and the effect of the group was not prominent. Furthermore, the effect of time was not statistically significant (F = 0.968, df = 5, P = 0.414) and SpO2 was not so different in the several times of evaluation. Finally, according to the results of the mentioned analysis, the difference in the group and time was not prominent and SpO2 changes during the study were approximately equal in the two groups.
The side effects of the anesthetic agents
Cochran's q-test analysis showed that the incidence of bradycardia and tachycardia on the beginning of the surgery after the incision, was 17.5% (7 cases), and 10 min after the beginning of the surgery was 30% (12 cases). In addition, they were seen in 7.5% (three patients), and 5% (two patients) after 30 and 60 min, respectively. The same results were repeated after 90 and 120 min, respectively.
| Discussion|| |
Preparing favorable ventilation and continues oximetry in any type of anesthetic procedure is essential and plays an important role not only for saving the safety of the patient but also for preventing the long-term complications of the anesthesia. In this study, the efficacy and the safety of two agents including DEX and REM were studied in the patients who underwent AVF formation. The result of our study showed that there is not any significant difference in using DEX or REM in the patients undergo AVF formation. Furthermore, other side effects of these two agents, for example, tachycardia and bradycardia were inappreciable.
Our study showed that there was not any significant difference in SpO2 between using REM or DEX. In the previous studies, the effect of these two agents on the oximetry parameters, side effects, and hemodynamic status of the patients was evaluated. The study of Xu T. was done among the patients who underwent awake intubation and compared two agents including DEX and REM. The results showed that the levels of SpO2 were not different by using any of these two agents. However, the study of St-Pierre et al. showed different results. They concluded that the frequency of decreasing in SpO2 was significantly higher in the REM group.
Most of the previous studies showed that DEX was superior to REM in stabilization of hemodynamic parameters. The study of Lee et al. was done among the elderlies with vertebroplasty and kyphoplasty for comparing DEX with REM. Their study revealed that the levels of SpO2 was higher in the patients of DEX group. Also, respiratory depression was lower in this group, but the analgesia was lower in comparison with REM group. The study of Janatmakan et al. showed that using infusion of DEX could prepare favorable hemodynamical situation in the patients undergoing spinal surgery. Furthermore, other studies showed that DEX is superior to REM in preventing respiratory depression.,,
In the meta-analysis done by Tang et al., the efficacy and the safety of DEX and REM in the aware patients who underwent endoscopic fiberoptic intubation were compared to each other. Both agents were acceptable and tolerated very well by the patients, but DEX was more effective in decreasing the incidence of hypoxia and memory recall of endoscopy. On the other hand, the study of Beloeil et al. in the noncardiac intermediate or major surgeries showed that DEX was not superior to REM. Furthermore, the serious side effects of DEX including hypoxemia and bradycardia were dominant. In the study done by Gazi et al., the patients who underwent hysteroscopy were studied. Their study showed that the postsurgical pain was lower in the DEX group and the hemodynamic parameters were more stable, but 30 min after the surgery, the mentioned parameters were more favorable in the REM group. Another study was done in the patients who underwent hysteroscopy by Park et al. and two combined agents were compared with each other including DEX-REM and propofol-REM. Their study revealed that in the first group with the combination of DEX, the prevalence of respiratory depression was lower and the hemodynamic complications were not higher.
According to the mentioned previous studies DEX can be superior to REM for preventing respiratory depression. Our study showed that there was not any significant difference in using DEX or REM in the anesthesiological procedures. It seems that in the critically ill or complicated patients DEX is a better choice. The patients with ESRD are the critical patients and they may be complicated with other underlying diseases, so DEX is preferable in this group of patients.
| Conclusion|| |
The results of our study showed that in the patients who underwent AVF formation, there was not any significant difference in the SpO2 measurement in different times of evaluation. Furthermore, the side effects of these two drugs on the heart rate and the incidence of bradycardia and tachycardia were low. It seems that although there is not any superiority in using DEX over REM in patients who undergo AVF formation, DEX is preferable. More studies on the higher number of groups of patients undergoing different surgeries, especially in the patients with underlying diseases and also, evaluating the other side effects of these agents are recommended.
This study was under the approval of the Iran University of Medical Sciences (IUMS) with the code of IR. IUMS.FMD. REC.1399.115 and was recorded in the clinical trial system with the ID of IRCT20200502047269N1. Date: 2021.24.1.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2]