|Year : 2020 | Volume
| Issue : 4 | Page : 379-385
A prospective randomized controlled trial using propofol or dexmedetomidine for conscious sedation in pediatric patients undergoing sclerotherapy
Rajeev Chauhan1, Ankur Luthra1, Sameer Sethi1, Nidhi Panda1, Shyam Charan Meena1, Vikas Bhatia2, Summit D Bloria1
1 Department of Anaesthesia, Postgraduate Institute of Medical Education & Research (PGIMER), Chandigarh, India
2 Department of Radiodiagnosis, Postgraduate Institute of Medical Education & Research (PGIMER), Chandigarh, India
|Date of Submission||16-Dec-2019|
|Date of Decision||27-Mar-2020|
|Date of Acceptance||30-Mar-2020|
|Date of Web Publication||19-Jan-2021|
Dr. Summit D Bloria
Department of Anaesthesia, Postgraduate Institute of Medical Education & Research (PGIMER), Chandigarh 160012.
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Aim: Sodium tetradecyl sulfate (STS) sclerotherapy in pediatric patients is usually undertaken under sedation inside digital subtraction angiography (DSA) suite. These patients are day-care patients and need adequate sedation for small duration. We performed this study to compare propofol and dexmedetomidine as sedative agents in these patients. Materials and Methods: Seventy American Society of Anesthesiologists (ASA) physical status I patients scheduled to undergo sclerotherapy for low-flow venous malformations under sedation were randomized to be administered either dexmedetomidine (Group D) or propofol (Group P). In Group D, initially 2 µg/kg of dexmedetomidine was administered over 10min (or till attainment of a Ramsay sedation score [RSS] of 5), followed by an infusion at the rate of 0.3 µg/kg/h. In Group P, propofol 1mg/kg bolus followed by an infusion at 100 µg/kg/min was administered, titrated to an RSS of 5. We measured intraoperative heart rate, blood pressure, respiratory rate, duration of procedure, and incidence of arterial desaturation, bradycardia, and respiratory depression in the two groups. Results: All the patients in both groups completed the procedure. The mean anesthesia time was significantly longer in Group D. Intraoperative heart rates remained comparable in the two groups, whereas systolic and diastolic BP were significantly higher in Group D throughout the procedure. No patient in Group D experienced arterial desaturation, whereas five patients in Group P reported a SpO2 of <90%. Conclusion: Both propofol and dexmedetomidine can be used for administering sedation in pediatric patients undergoing sclerotherapy for superficial venous malformations in DSA suite. Although propofol provides a rapid onset and reduced duration of action, dexmedetomidine provides reduced episodes of arterial desaturation and respiratory depression.
Keywords: Sclerotherapy, pediatrics, venous malformations
|How to cite this article:|
Chauhan R, Luthra A, Sethi S, Panda N, Meena SC, Bhatia V, Bloria SD. A prospective randomized controlled trial using propofol or dexmedetomidine for conscious sedation in pediatric patients undergoing sclerotherapy. J Pediatr Neurosci 2020;15:379-85
|How to cite this URL:|
Chauhan R, Luthra A, Sethi S, Panda N, Meena SC, Bhatia V, Bloria SD. A prospective randomized controlled trial using propofol or dexmedetomidine for conscious sedation in pediatric patients undergoing sclerotherapy. J Pediatr Neurosci [serial online] 2020 [cited 2021 Mar 4];15:379-85. Available from: https://www.pediatricneurosciences.com/text.asp?2020/15/4/379/307363
| Introduction|| |
Venous malformations are found in 1–2 newborns per 1000 births, and their prevalence is around 1%. They are most commonly found in head and neck. Sclerotherapy with sodium tetradecyl sulfate (STS) foam under ultrasound guidance inside a digital subtraction angiography (DSA) suite is an effective treatment modality for low-flow venous malformations.,
STS sclerotherapy is carried out under local anesthesia or minimal sedation in adult patients. However, performing the procedure in pediatric patients involves the dual challenge of managing pediatric patients and that too, in a remote area. General anesthesia (GA) has been used in children for sclerotherapy of complex lesions or lesions involving the airway. However, most of the superficial and simple venous malformations can be performed under sedation. Sedation minimizes discomfort, improves the experience of patient, and reduces the risk of procedural complications by ensuring immobility. However, the patient’s normal protective mechanisms are weakened, and cardiac, respiratory, and cognitive complications can occur. Hence, it is imperative to use drugs, which provide a calm and cooperative patient during the procedure without any side effects. The ideal drug would be the one that does not affect respiration and hemodynamics, provides analgesia and amnesia, and has a rapid onset and recovery. A number of drug regimes are used for sedating the pediatric patients. The most common drugs used include propofol, ketamine, benzodiazepines, and opioids., Each of these drugs has its share of advantages and disadvantages.
Propofol is an intensely popular drug for sedation, due to its rapid onset, short duration of action, antiemetic properties, and smooth recovery. However, its use in patients aged less than 3 years is still not Food and Drug Administration (FDA) recommended. Many researchers have shown occurrence of adverse effects such as hypoventilation, apnea, hypotension, and loss of airway reflexes when propofol is used for sedation., Hence, the search for ideal drug for pediatric sedation continues.
Dexmedetomidine is an α-2 agonist with properties of sedation, anxiolysis, and analgesia. It has been used to administer sedation in pediatric patients undergoing procedures such as magnetic resonance imaging (MRI), minor surgeries, and vitreoretinal surgery, and has been proven to be safe and to provide adequate sedation for these procedures.,, Its main advantages over other sedative agents include minimal depression of respiratory drive and sedation similar to natural sleep, during which patients can be woken up easily.
The primary aim of this trial was to assess the efficacy of dexmedetomidine versus propofol for monitored anesthesia care (MAC) for sclerotherapy in interventional radiology procedures in pediatric patients.
| Materials and Methods|| |
After obtaining approval from the institutional ethics committee ([INT/IEC/2018/1088] dated August 18, 2018), this prospective randomized controlled trial was registered in the Clinical Trial Registry of India (CTRI/2019/01/016885 [Registered on: January 3, 2019)). The study was carried out in adherence to the principles of the Declaration of Helsinki in a tertiary care center in North India over 7 months.
In total, 70 pediatric patients aged 2–12 years, scheduled for sclerotherapy for low-flow venous malformations under sedation and belonging to American Society of Anesthesiologists (ASA) physical status I were included in the study. Written informed consent was obtained from all the patients’ parents before enrolling them in the trial. Patients with predicted difficult airway or history of allergy to propofol, fentanyl, or dexmedetomidine were excluded from the trial.
All patients were premedicated with 0.5mg/kg oral midazolam at least 10min before the procedure. On arrival in the procedure room, a pulse oximeter, electrocardiogram (ECG) electrodes, and an appropriate sized blood pressure (BP) cuff was attached to the patient. An intravenous (IV) cannula was inserted after inhalational induction with sevoflurane. Thereafter, sevofluare administration was stopped, and the patients were randomly assigned into either of the two groups using a computer-generated random number table: Group P and Group D. Patients in both the groups received IV fentanyl 2 µg/kg just after securing of an IV line.
In Group P, propofol was used for sedation. Ramsay sedation scale (RSS) was used to assess the level of sedation. The initial dose of propofol used was 1mg/kg bolus followed by a continuous infusion at 100 µg/kg/min, titrated to a sedation score of 5 on RSS. Thereafter, the sedating physician had the discretion of reducing the propofol infusion dose by 25 µg/kg/min every 5min. Supplemental dose of propofol at 0.5–1mg/kg was given, and infusion rate was increased by 25 µg/kg/min (to a maximum of 150 µg/kg/min) whenever the patient showed any movement.
In Group D, initially 2 µg/kg of dexmedetomidine was initiated immediately after placement of IV cannula and administered over 10min (or till the attainment of an RSS of 5) followed by a continuous infusion at the rate of 0.3 µg/kg/h. If RSS of 5 was not achieved after infusion of the study drug for 10min, the infusion rate of the study drugs was increased by 0.3 µg/kg/h to a maximum of 1.5 µg/kg/h.
Patients remained on spontaneous breathing without an artificial airway. Respiratory rate, arterial oxygen saturation (using pulse oximetry), and clinical observation of chest movement were used to assess the ventilator function. An SpO2 reading of less than 90% was considered as an episode of desaturation. If the SpO2 level fell below 90% for 30s, the procedure was interrupted, bag mask ventilation was initiated, and the study drug infusion was discontinued temporarily. The procedure was started again once the SpO2 returned to normal. A heart rate of less than 60 beats per minute was considered as an episode of bradycardia. The drug infusion was temporarily stopped and injection atropine was administered in the event of bradycardia. A decrease in the mean BP of more than 20% of baseline was considered as hypotension and was managed by stopping the drug administration and the administration of IV fluids. A respiratory rate of less than 12 breaths per minute was considered as an episode of respiratory depression. At the end of the sclerotherapy, the drug infusion was stopped, and the children were then shifted to the recovery room.
Statistical analysis: At the end of the study, the data were collected and analyzed statistically. Intergroup statistical analysis was performed using Student t test, and nonparametric data were analyzed using chi‑square test. Comparison of continuous data between groups was done using analysis of variance (ANOVA). Comparison of categorical data between groups was done using Fisher’s exact test. P < 0.05 was considered as statistically significant, and P < 0.001 was considered highly significant.
| Results|| |
A total of 73 children were assessed for eligibility for inclusion in the study. Parents of 3 patients declined to give consent for the study and were excluded. Rest 70 patients were included in the study [Figure 1]. Demographic characteristics including age, gender, weight, and ASA physical status are described in [Table 1].
All the patients in both the groups were able to complete the procedure. The mean duration of procedure was comparable in the two groups (P value = 0.406). However, the mean anesthesia time was significantly longer in dexmedetomidine group (P < 0.001) [Table 2]. This difference is because the onset of sedation was slower in Group D. Two patients in each group had two episodes of movement during the procedure, whereas the number of patients having a single episode of movement during the procedure was nine in dexmedetomidine group and three in propofol group. No patient in either group experienced more than two episodes of movement during the procedure.
|Table 2: Comparison of anesthesia time and procedure time in the two groups|
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At the beginning of the study, heart rate in both the groups was comparable. As the duration of infusion increased in both the groups, there was a decrease in heart rate. In both the groups, heart rate was comparable throughout the procedure. The incidence of bradycardia was however more in dexmedetomidine group (20%) as compared to the propofol group (5.7%) [Figure 2].The systolic and diastolic BP levels were comparable in the two groups at the beginning of procedure. Throughout the period of sedation, the systolic and diastolic BP levels in dexmedetomidine group were significantly higher than those in Group P [Figure 3] and [Figure 4].The incidence of various complications in the two groups is shown in [Table 3]. The number of patients requiring increased infusion of study drug was significantly higher in Group D (9 [25.7%]) as compared to Group P (5 [14.2%]). More patients in propofol group had desaturation episodes and respiratory depression.
|Figure 4: Diastolic BP trends (p* implies a statistically significant difference between the two groups)|
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| Discussion|| |
Sclerotherapy is an established nonsurgical intervention for venous malformations. Injection of the sclerosant causes intense pain. It is thus imperative that the child remains motionless during the procedure as sudden motion during the procedure can cause drug spillage and needle injury to the patient. Also, these patients are not usually admitted in the hospital and patients return to their homes after a small period of observation in the recovery room. Hence, the need of a drug for sedation, which would be short acting but ensures adequate sedation during the procedure. To the best of our knowledge, this is the first study comparing two sedative drugs for pediatric patients undergoing STS foam injection in DSA suite.
Most of the cases of sclerotherapy of superficial venous malformations in children are undertaken under sedation. Our aim was to compare the sedation with propofol to the sedation with dexmedetomidine in pediatric patients undergoing sclerotherapy for venous malformations. Although various authors have previously compared sedation with dexmedetomidine and propofol in pediatric patients for various procedures, the data for sclerotherapy are lacking as of now.
In this study, all the patients were able to undergo sclerotherapy in both the groups. This suggests the ability of both propofol and dexmedetomidine to provide effective sedation for sclerotherapy in pediatric patients as “sole agents” when used along with opioids.
There was a trend of lowering of heart rate in both the groups as the procedure progressed. However, the heart rates remained comparable in both the groups throughout the procedure.
When we compared intraoperative systolic and diastolic BP levels in the two groups, we found that the dexmedetomidine group had better maintenance of intraoperative BP levels throughout the procedure, whereas the propofol group patients had lower BP levels. Mahmoud et al. and Abulebda et al. in their studies had got similar results as us. Also, the propofol group had more hypotensive episodes.
However, the anesthesia time was found to be significantly higher in the dexmedetomidine group. This was partly because the dexmedetomidine group patients were initially administered an infusion of dexmedetomidine over 10min, whereas the propofol group patients received bolus doses of propofol. Also, similar results were obtained when these two drugs were compared for providing sedation for MRI procedures in children.,
Episodes of bradycardia were significantly more in the dexmedetomidine group. Bradycardia is a known complication with the use of dexmedetomidine, which was also shown in a study by Kamal et al.
The incidence of desaturation episodes and decrease in respiratory rate was more in propofol group. In a non-operation theatre setting, such as DSA suite, arterial desaturation can lead to disastrous consequences; hence in this attribute, dexmedetomidine may be a better drug than propofol. Similar results were also shown by other authors in studies involving pediatric patients.,
Our study did have some limitations. Our patients included many children undergoing repeated sclerotherapy procedures, and sedation doses needed in these patients may be different from those undergoing sedation for the first time. Also, we did not use objective monitors of depth of anesthesia such as bispectral Index or entropy in our patients.
| Conclusion|| |
Both propofol and dexmedetomidine can be used for administering sedation in pediatric patients undergoing sclerotherapy for superficial venous malformations in DSA suite. Although propofol provides a rapid onset and reduced duration of action, dexmedetomidine provides reduced episodes of arterial desaturation and respiratory depression.
All procedures performed in the studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
We certify that the study was performed in accordance to the established ethical standards for medical trials.
Declaration of patient consent
The authors certify that they have obtained all appropriate patient consent forms. In the form the patient(s) has/have given his/her/their consent for his/her/their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4]
[Table 1], [Table 2], [Table 3]