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Abstract
Introduction
Methods
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ORIGINAL ARTICLE
Year : 2018  |  Volume : 19  |  Issue : 2  |  Page : 56-60
 

Propofol versus meperidine and midazolam as a conscious sedation in percutaneous vertebroplasty: Prospective randomized trial


1 Department of Anesthesiology and Intensive Care Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt
2 Department of Neurosurgery, Faculty of Medicine, Tanta University, Tanta, Egypt

Date of Submission09-Jul-2018
Date of Acceptance18-Sep-2018
Date of Web Publication15-Nov-2018

Correspondence Address:
Dr. Asmaa Fawzy Amer
Department of Anesthesiology and Intensive Care Medicine, Faculty of Medicine, Tanta University, El-Geish Street, Postal Code: 31257, Tanta
Egypt
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/TheIAForum.TheIAForum_31_18

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  Abstract 


Background: Percutaneous vertebroplasty is a minimally invasive procedure, usually performed under local anesthesia with either general anesthesia or conscious sedation. In this study, we compared the efficacy and safety of propofol versus the combined use of meperidine and midazolam for conscious sedation in percutaneous vertebroplasty.
Methods: This prospective randomized study was conducted within 6 months on sixty patients undergoing percutaneous vertebroplasty. The patients were divided into two equal groups: Group I received propofol, while Group II received meperidine and midazolam. The time required to achieve sufficient sedation, emergence time, recovery time, hemodynamic monitoring throughout the procedure, patient's and surgeon's satisfaction, and incidence of postprocedural complications were all recorded. Bispectral index and end-tidal carbon dioxide measurement were used to assess sedation level and to ensure patient safety throughout the procedure.
Results: Demographic data from both groups were comparable. The time taken to reach sufficient sedation, emergence time, and recovery time were shorter in Group I than that in Group II (P = 0.001). Patients in both groups were hemodynamically stable throughout the procedure. Surgeon's satisfaction was higher in Group I (96%) than that in Group II (80%), while patient's satisfaction was nearly equal in both groups, without significant postoperative complications.
Conclusions: Propofol was superior to the combined use of midazolam and meperidine for conscious sedation in percutaneous vertebroplasty. It helped in achieving a moderate sedation level in less time and offered rapid emergence from sedation, with shorter recovery time.


Keywords: Conscious sedation, meperidine, midazolam, percutaneous vertebroplasty, propofol


How to cite this article:
Amer AF, Salama ER, Elatrozy HI. Propofol versus meperidine and midazolam as a conscious sedation in percutaneous vertebroplasty: Prospective randomized trial. Indian Anaesth Forum 2018;19:56-60

How to cite this URL:
Amer AF, Salama ER, Elatrozy HI. Propofol versus meperidine and midazolam as a conscious sedation in percutaneous vertebroplasty: Prospective randomized trial. Indian Anaesth Forum [serial online] 2018 [cited 2019 Sep 16];19:56-60. Available from: http://www.theiaforum.org/text.asp?2018/19/2/56/245541





  Introduction Top


Vertebroplasty is a minimally invasive procedure involving stabilization of a collapsed vertebra by image-guided injection of medical-grade bone cement.[1] This procedure can be performed under local anesthesia combined with either conscious sedation or general anesthesia; neurosurgeons prefer conscious sedation to allow early assessment of motor function.[2]

According to the modified Ramsay Sedation Scale, conscious sedation is a moderate type of sedation, which keeps patients calm and allows them to tolerate diagnostic or therapeutic procedures.[3] During conscious sedation, patients can maintain patent airway and spontaneous ventilation throughout the intervention. However, it is a challenge for anesthetists to apply conscious sedation to patients lying in prone position.[4] Moreover, some patients might suffer a deeper sedation level than intended, which mandates urgent intervention to maintain airway patency and to apply advanced life support.

In this study, patients' safety was ensured by continuous monitoring with capnogram and the Bispectral Index (BIS) throughout the procedure.


  Methods Top


This prospective, randomized study was carried out after approval from the institute's Ethics Committee (31961/12/17), and written informed consent was obtained from all patients. The study included sixty American Society of Anesthesiologists (ASA) class I and II patients, of both sexes, aged between 18 and 65 years, having vertebral compression fractures, and undergoing percutaneous vertebroplasty.

Patients with known allergies to any of the tested drugs, pregnant patients, patients on sustained release narcotics, substance abusers, patients with body mass index (BMI) above 40, and those who refused to sign the consent were all excluded from the study.

Patients involved in the study were not premedicated and were kept fasting as per the ASA recommendation.

On arrival to the operating room, a peripheral venous access was secured to each patient, and they were asked to lie in prone position. Lactated Ringer's solution was administered at a rate of 4 ml/kg/h. All patients underwent noninvasive monitoring using an electrocardiogram, a pulse oximeter, noninvasive blood pressure measurement, end-tidal carbon dioxide (EtCO2) measurement, and bispectral probing. Baseline vital parameters were recorded before induction of sedation.

EtCO2 was measured by side-stream capnography using a nasal cannula. Both heart rate (HR) and mean arterial pressure (MAP) were noted every 5 min, with continuous monitoring throughout the procedure for SpO2, EtCO2, and depth of sedation by BIS.

The patients were randomly assigned to two equal groups (n = 30) using computer-generated random numbers concealed in sealed opaque envelopes.

Group I

Group I patients received 1 mg/kg propofol administered intravenously as a bolus dose, followed by 10–20 mg incrementally to keep the BIS between 80% and 85%.

Group II

Initially, 0.4 mg/kg of meperidine was administered intravenously as a bolus dose, followed by 0.05 mg/kg of midazolam. Booster doses of both drugs were given simultaneously to maintain the BIS between 80% and 85%: meperidine (5–10 mg) and midazolam (1–2 mg).

Flumazenil and naloxone, the antagonists of midazolam and meperidine, as well as all the equipment needed for resuscitation, were available.

If any signs of oversedation were observed, such as a respiratory rate <10 breaths per minute, SpO2 <95%, increased EtCO2, or a BIS <80%, administration of sedative drugs was stopped to attain the originally intended sedation level and to apply advanced life support if needed.

Sedation was induced, in both groups, at a slow pace, allowing the drugs enough time (about 90–120 s) to achieve their peak plasma levels and ensure an adequate sedation level (moderate sedation) before starting the procedure.

Upon attaining moderate sedation in both groups, the site of the spinal puncture was sterilized using povidone-iodine solution, and then a subcutaneous infiltration of lidocaine was performed, followed by deep infiltration of ropivacaine (to periosteum) and then insertion of the needle for percutaneous vertebroplasty.

On completion of the procedure, increments of the study drug were stopped, and the patients were gently shook by the shoulders while asking them to open their eyes to determine the emergence time. The patients were then transferred to the recovery area, where pulse oximetry, HR, and blood pressure were monitored. Patients were discharged when modified Aldrete score ≥9 was achieved.

Patient's and surgeon's satisfaction were assessed to detect the efficacy of the studied drugs, using a satisfaction score (1 = very satisfied, 2 = satisfied, 3 = unsatisfied, and 4 = very unsatisfied). We considered the scores 1 and 2 as satisfied and 3 and 4 as unsatisfied, and the percentage of satisfaction was calculated for both groups. All encountered complications were recorded, including oxygen saturation <90%, hypotension (blood pressure <90/50 mmHg), and the need to reverse the sedation or to support the respiration with bag-mask ventilation.

The primary outcome measured is the emergence time, which is the time between termination of drug administration and the patients opening their eyes in response to commands. The secondary outcome measured is the time required to achieve a sufficient sedation level. We also assessed the recovery time, which is the time between postanesthesia care unit admission and obtaining Aldrete scores of 9, patients' and surgeons' satisfaction, hemodynamic measure throughout the procedure, and incidence of postprocedural nausea and vomiting.

Statistical analysis

Simulating a previous similar study,[5] the sample size was calculated using the G * Power version 3.00.10 software, Germany (Windows XP, Windows Vista, and Mac OS X 10.4), which revealed that at least 26 patients are needed in each group to achieve 90% power, α error of 0.05, and a significant difference of 5 min in emergence time. To overcome dropout cases, we conducted our study on thirty patients for each group.

Data were analyzed using the Statistical Package for the Social Sciences version 20 (SPSS Inc., Chicago, IL, USA). Quantitative data were expressed as mean ± standard deviation. Qualitative data were expressed as frequency and percentage. In dependent samples, t-test of significance was used when comparing between two means. Chi-square test of significance was used to compare proportions between two qualitative parameters.


  Results Top


Out of 64 patients undergoing percutaneous vertebroplasty during the study period, only 60 were enrolled in the current study, as one patient refused to participate in the study and three were excluded (one had a BMI over 40, one was ASA III, and one had a coagulopathy) [Figure 1].
Figure 1: Consort flow diagram

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Demographic data including age, sex, BMI, ASA status, and procedure time in both groups were comparable [Table 1].
Table 1: Patients' demographic data and length of procedure

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Time to achieve the satisfactory sedation level was significantly less in Group I, 66.2 ± 13.68 s versus 151.0 ± 35.37 s in Group II (P = 0.001). The emergence time was shorter in Group I (7.0 ± 1.80 min) than in Group II (11.90 ± 3.55 min) (P = 0.001). Recovery time was significantly decreased in Group I (24.37 ± 4.76 min) compared to Group II (36.13 ± 6.92 min) (P = 0.001) [Table 2].
Table 2: Collected intraoperative and postoperative data

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HR and MAP in both groups were comparable throughout the procedure [Figure 2] and [Figure 3].
Figure 2: Mean arterial blood pressure (mmHg) changes throughout the procedure in both groups. Data presented as mean ± standard deviation

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Figure 3: Heart rate (beat/minute) changes throughout the procedure in both groups. Data presented as mean ± standard deviation

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Patients' satisfaction during the postoperative period in both groups was comparable (P = 0.640), while surgeons' satisfaction was higher in Group I (96%) compared to that of Group II (80%). The incidence of nausea and vomiting was statistically insignificant in both groups (P = 0.389) [Table 2].

Only one patient in Group I suffered hypotension, but it was transient and improved upon administering a normal saline infusion. There were no severe adverse events requiring reversal agents, bag-mask ventilation, or intubation throughout the study.


  Discussion Top


Percutaneous vertebroplasty is a safe and effective image-guided method of treatment for several pathological conditions of the vertebra. It is a minimally invasive procedure based on consolidation of a vertebral body.

Conscious sedation was always used in short diagnostic or therapeutic procedures, but only few studies have evaluated conscious sedation in prone position.[6],[7]

The aim of combined administration of midazolam and meperidine in this study was to avoid the use of high doses from a single anesthetic drug and also to benefit from their synergistic effects. Midazolam is a water-soluble, short-acting benzodiazepine. It provides good sedation and excellent amnesia.[8] Some physicians even consider it the premedication of choice for adults.[9] Meperidine, however, is a synthetic narcotic analgesic, which acts predominantly on mu opioid receptors and is used to relieve moderate-to-severe pain.[10]

In the current study, the emergence time was shorter in Group I compared to Group II (7.0 ± 1.80 min vs. 11.90 ± 3.55 min, respectively). Kramer et al.[11] also reported similar results.

Patients in the propofol group achieved the sufficient sedation level faster than the group administered meperidine and midazolam (66.2 ± 13.68 s vs. 151.0 ± 35.37 s, respectively), which is similar to the results of the study by Mandel et al.[12] The pharmacokinetic properties of propofol explain this result. Propofol is a rapidly acting sedative and hypnotic drug associated with quick recovery, its hepatic clearance is fast, and it does not yield active metabolites.[13]

Moreover, in the current study, the propofol group demonstrated shorter recovery time than the combined meperidine and midazolam group, which is similar to the results of Kramer et al.[11] and Koshy et al.[14] who compared propofol with combined meperidine and midazolam as conscious sedatives for patients undergoing gastrointestinal endoscopy.

Vital signs of patients in both groups were comparable. Hannallah et al.[15] and Bahal-O'Mara et al.[16] also reported similar results.

The incidence of nausea and vomiting in both groups was very low and comparable, as propofol has antiemetic properties. In contrast, Krenn et al.[17] reported a higher incidence of nausea and vomiting after sedation with propofol.

Based on the results of the current study, no statistically significant difference was detected between both groups regarding patient's satisfaction, unlike the results of Koshy et al.[14] who reported that patients who received propofol were more comfortable than patients who received midazolam and meperidine.

The only limitation of the current study is that it was unblinded throughout the procedure. Thus, assigning patients to each of the two groups may be biased.


  Conclusions Top


Propofol is superior to the combined use of midazolam and meperidine for conscious sedation in percutaneous vertebroplasty. It requires shorter time to achieve sufficient sedation level and is associated with rapid emergence and short recovery time, with no additional risk or side effects.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Ploeg WT, Veldhuizen AG, The B, Sietsma MS. Percutaneous vertebroplasty as a treatment for osteoporotic vertebral compression fractures: A systematic review. Eur Spine J 2006;15:1749-58.  Back to cited text no. 1
    
2.
Al-Ali F, Barrow T, Luke K. Vertebroplasty: What is important and what is not. AJNR Am J Neuroradiol 2009;30:1835-9.  Back to cited text no. 2
    
3.
Sheahan CG, Mathews DM. Monitoring and delivery of sedation. Br J Anaesth 2014;113 Suppl 2:ii37-47.  Back to cited text no. 3
    
4.
Sen J, Sen B. A comparative study on monitored anesthesia care. Anesth Essays Res 2014;8:313-8.  Back to cited text no. 4
  [Full text]  
5.
Cinar K, Yakut M, Ozden A. Sedation with midazolam versus midazolam plus meperidine for routine colonoscopy: A prospective, randomized, controlled study. Turk J Gastroenterol 2009;20:271-5.  Back to cited text no. 5
    
6.
De Berti G, Maggi M, Conigliaro R, Levrini G, Salzano S, Ghadirpour R, et al. Administration of conscious sedation by a neuroradiology team during percutaneous vertebroplasty and spinal biopsy procedures. Neuroradiology 2012;54:231-7.  Back to cited text no. 6
    
7.
Della Puppa A, Andreula C, Frass M. Assisted sedation: A safe and easy method for pain-free percutaneous vertebroplasty. Minerva Anestesiol 2008;74:57-62.  Back to cited text no. 7
    
8.
Ross WA. Premedication for upper gastrointestinal endoscopy. Gastrointest Endosc 1989;35:120-6.  Back to cited text no. 8
    
9.
Bell GD. Review article: Premedication and intravenous sedation for upper gastrointestinal endoscopy. Aliment Pharmacol Ther 1990;4:103-22.  Back to cited text no. 9
    
10.
Mather LE, Tucker GT, Pflug AE, Lindop MJ, Wilkerson C. Meperidine kinetics in man. Intravenous injection in surgical patients and volunteers. Clin Pharmacol Ther 1975;17:21-30.  Back to cited text no. 10
    
11.
Kramer KJ, Ganzberg S, Prior S, Rashid RG. Comparison of propofol-remifentanil versus propofol-ketamine deep sedation for third molar surgery. Anesth Prog 2012;59:107-17.  Back to cited text no. 11
    
12.
Mandel JE, Tanner JW, Lichtenstein GR, Metz DC, Katzka DA, Ginsberg GG, et al. A randomized, controlled, double-blind trial of patient-controlled sedation with propofol/remifentanil versus midazolam/fentanyl for colonoscopy. Anesth Analg 2008;106:434-9.  Back to cited text no. 12
    
13.
Dubois A, Balatoni E, Peeters J, Baudoux M. Use of propofol for sedation during gastrointestinal endoscopies. Anaesthesia 1988;43:75-80.  Back to cited text no. 13
    
14.
Koshy G, Nair S, Norkus EP, Hertan HI, Pitchumoni CS. Propofol versus midazolam and meperidine for conscious sedation in GI endoscopy. Am J Gastroenterol 2000;95:1476-9.  Back to cited text no. 14
    
15.
Hannallah M, David M, Carroll J, Haddad N, Charabaty A, Barton F. Comparison of propofol vs. propofol/remifentanil anesthesia in upper GI endoscopic ultrasound examination (EUS). Ambul Surg 2012;18:42-4.  Back to cited text no. 15
    
16.
Bahal-O'Mara N, Nahata MC, Murray RD, Linscheid TR, Fishbein M, Heitlinger LA, et al. Sedation with meperidine and midazolam in pediatric patients undergoing endoscopy. Eur J Clin Pharmacol 1994;47:319-23.  Back to cited text no. 16
    
17.
Krenn H, Deusch E, Jellinek H, Oczenski W, Fitzgerald RD. Remifentanil or propofol for sedation during carotid endarterectomy under cervical plexus block. Br J Anaesth 2002;89:637-40.  Back to cited text no. 17
    


    Figures

  [Figure 1], [Figure 2], [Figure 3]
 
 
    Tables

  [Table 1], [Table 2]



 

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