مقایسه دوز کم پروپوفول با میدازولام بر روی علائم همودینامیک مادر و آپگار نوزادان در زنان تحت بی‌حسی اسپاینال در عمل جراحی سزارین: یک مطالعه کارآزمایی بالینی تصادفی شده دوسویه‌کور

نوع مقاله : اصیل پژوهشی

نویسندگان

1 استادیار گروه بیهوشی، مرکز تحقیقات بیهوشی، مراقبت‌های ویژه و کنترل درد، دانشکده پزشکی، دانشگاه علوم پزشکی هرمزگان، بندرعباس، ایران

2 استادیار گروه بیهوشی، دانشکده پزشکی، دانشگاه علوم پزشکی شیراز، شیراز، ایران.

3 دکترای تخصصی ژنتیک پزشکی، پزشک قانونی، مرکز تحقیقات سازمان پزشکی قانونی کشور، تهران، ایران.

4 استادیار گروه زنان و مامایی، مرکز تحقیقات سلامت و بیماری‌های زنان، دانشکده پزشکی، دانشگاه علوم پزشکی جهرم، جهرم، ایران.

5 مربی گروه بیهوشی، مرکز تحقیقات بیهوشی و کنترل درد، دانشکده پزشکی، دانشگاه علوم پزشکی جهرم، جهرم، ایران.

6 دانشجوی پزشکی، کمیته تحقیقات دانشجویی، دانشکده پزشکی، دانشگاه علوم پزشکی جهرم، جهرم، ایران.

7 دانشیار گروه بیهوشی، دانشکده پزشکی، دانشگاه علوم پزشکی جهرم، جهرم، ایران.

چکیده

مقدمه: بی‌حسی ناحیه‌ای، روش انتخابی در جراحی سزارین می‌باشد. داروهای خواب‌آور داخل وریدی که در القاء بیهوشی استفاده می‌شوند، به‌سرعت از جفت عبور کرده و ممکن است باعث دپرسیون تنفسی جنین شوند. مطالعه حاضر با هدف مقایسه دوز کم پروپوفول با میدازولام بر روی علائم همودینامیک مادران و آپگار نوزادان در زنان تحت بی‌حسی اسپاینال در عمل جراحی سزارین انجام شد.
روش‌کار: در این مطالعه کارآزمایی بالینی تصادفی شده دو‌سویه‌کور که در سال 1392 در شهرستان جهرم انجام شد، 42 بیمار با کلاس بیهوشی I و II تحت بی‌حسی اسپاینال به دو گروه مساوی تزریق 20 میلی‌گرم پروپوفول و 5/1 میلی‌گرم میدازولام همزمان با انجام بی‌حسی اسپاینال قرار گرفتند. علائم همودینامیک مادر در دقایق 1، 3، 5، 10، 15، 30 و 60 دقیقه بعد از بی‌حسی اسپاینال و آپگار نوزادان در دقایق 1 و 5 بعد از به‌دنیا آمدن سنجیده شد. تجزیه و تحلیل داده‌ها با استفاده از نرم‌افزار آماری SPSS (نسخه 21) و آزمون‌ من‌ویتنی انجام شد. میزان p کمتر از 05/0 معنی‌دار در نظر گرفته شد.
یافته‌ها: بین گروه‌های میدازولام و پروپوفول از لحاظ فشارخون سیستول و دیاستول، اشباع اکسیژن و ضربان قلب در زمان‌های مختلف و از لحاظ آپگار نوزادان تفاوت آماری معنی‌داری وجود نداشت (05/0p>).
نتیجه‌گیری: با توجه به نتایج مطالعه و عدم تفاوت دو گروه از نظر آپگار نوزادان و نوسانات متغیرهای همودینامیک مادر، می‌توان نتیجه گرفت در شرایط معمولی دوزهای کم پروپوفول و میدازولام برای جراحی سزارین، از نظر بالینی تفاوت بارزی بر آپگار نوزاد و متغیرهای همودینامیک مادر ندارند و می‌توان بسته به شرایط و تجربه متخصص بیهوشی از داروهای مورد نظر استفاده کرد.

کلیدواژه‌ها


عنوان مقاله [English]

Low doses of propofol and midazolam on maternal hemodynamic symptoms and neonatal Apgar in women undergoing spinal anesthesia in cesarean section: A double-blind randomized clinical trial study

نویسندگان [English]

  • Majid Vatankhah 1
  • Seyed Ebrahim Sadeghi 2
  • Mohammad Zarenezhad 3
  • Athar Rasekh Jahromi 4
  • Navid Kalani 5
  • Naser Hatami 6
  • Farshid Javdani 6
  • Hasan Zabetian 7
1 Assistant Professor, Department of Anesthesiology, Anesthesiology & Critical Care and Pain Management Research Center, Faculty of Medicine, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.
2 Assistant Professor, Department of Anesthesiology, Faculty of Medicine, Shiraz University of Medical sciences, Shiraz, Iran.
3 PhD in Medical Genetic, Department of Forensic Sciences, Iranian Legal Medicine Research Center, Tehran, Iran.
4 Assistant Professor, Department of Obstetrics and Gynecology, Women’s Health and Disease Research Center, Faculty of Medicine, Jahrom University of Medical Sciences, Jahrom, Iran.
5 Instructor, Department of Anesthesiology, Anesthesiology and Pain Management Research Center, Faculty of Medicine, Jahrom University of Medical Sciences, Jahrom, Iran.
6 Medical student, Student Research Committee, Faculty of Medicine, Jahrom University of Medical Sciences, Jahrom, Iran.
7 Associate Professor, Department of Anesthesiology, Faculty of Medicine, Jahrom University of Medical Sciences, Jahrom, Iran.
چکیده [English]

Introduction: Regional anesthesia is the method of choice in cesarean section. Intravenous sleeping pills used to induce anesthesia quickly cross the placenta and cause fetal respiration depression. This study was performed with aim to compare the low dose of propofol with midazolam on the maternal hemodynamics symptoms and neonatal Apgar in women undergoing spinal anesthesia in cesarean section.
Methods: In this double-blind randomized clinical trial study which was performed in Jahrom in 2013, 42 patients with anesthesia classes I and II underwent spinal anesthesia and were placed in two equal groups of injection of propofol 20 mg and midazolam 1.5 mg along with spinal anesthesia. Symptoms of maternal hemodynamics were measured at 1, 3, 5, 10, 15, 30, and 60 minutes after spinal anesthesia and neonatal apgar at 1 and 5 minutes after birth. Data were analyzed by SPSS software (version 21) and Mann-Whitney test. p < 0.05 was considered statistically significant.
Results: There was no significant difference between midazolam and propofol groups in terms of systolic and diastolic blood pressure, Blood O2 saturation, and hear rate at different times and neonatal Apgar (P> 0.05).
Conclusion: Considering the results of the study and no difference between the two groups in terms of neonatal Apgar and fluctuations of maternal hemodynamic variables, it can be concluded that under normal conditions, low doses of propofol and midazolam for cesarean section clinically have no significant difference on neonatal Apgar and hemodynamic variables; both drugs can be used depending on the condition and experience of the anesthesiologist.

کلیدواژه‌ها [English]

  • Cesarean section
  • Hemodynamic Symptoms
  • Midazolam
  • Neonatal Apgar
  • Propofol
  1. Bryson GL, MacNeil R, Jeyaraj LM, Rosaeg OP. Small dose spinal bupivacaine for Cesarean delivery does not reduce hypotension but accelerates motor recovery. Canadian Journal of Anesthesia 2007; 54(7):531-7.
  2. Adetunji A, Ajadi RA. Repeat bolus versus continues propofol infusion technique. J Israel Veterinary Med Associ 2002; 57(4):35-50.
  3. Chestnut DH, Wong CA, Tsen LC, Ngan Kee WD, Beilin Y, Mhyre J. Chestnut's Obstetric Anesthesia: Principles and Practice. 5nd ed. Saunders; 1999.
  4. Jirasiritham S, Tantivitayatan K, Sirivararom P. Over half MAC sevoflurane in cesarean section. J Med Assoc Thai 2005; 88(7):914-20.
  5. Belzarena SD. Clinical effects of intrathecally administered fentanyl in patients undergoing cesarean section. Anesthesia & Analgesia 1992; 74(5):653-7.
  6. Tarhan Ö, Canbay Ö, Celebi N, Uzun S, Sahin A, Coşkun F, et al. Subhypnotic doses of midazolam prevent nausea and vomiting during spinal anesthesia for cesarean section. Minerva anestesiologica 2007; 73(12):629-33.
  7. Fung BK, Gislefoss AJ, Ho ES. The sedative effect of intravenous injection of low dose midazolam during spinal anesthesia in cesarean section. Ma zui xue za zhi= Anaesthesiologica Sinica 1992; 30(3):159-62.
  8. Frölich MA, Burchfield DJ, Euliano T, Caton D. A single dose of fentanyl and midazolam prior to Cesarean section have no adverse neontal effects. Canadian Journal of Anesthesia 2006; 53(1):79-85.
  9. Orbach-Zinger S, Ginosar Y, Elliston J, Fadon C, Abu-Lil M, Raz A, et al. Influence of preoperative anxiety on hypotension after spinal anaesthesia in women undergoing Caesarean delivery. British journal of anaesthesia 2012; 109(6):943-9.
  10. Tripathi M, Nath SS, Chaudhary A, Singh PK, Pandey CM. Patient controlled sedation during central neuraxial anesthesia. Journal of postgraduate medicine 2009; 55(2):108-12.
  11. Verma RK, Paswan AK, Prakash S, Gupta SK, Gupta PK. Sedation with propofol during combined spinal epidural anesthesia: Comparison of dose requirement of propofol with and without BIS monitoring. Anaesthesia, Pain & Intensive Care 2019: 14-7.
  12. Ao L, Shi J, Bai Y, Zheng Y, Gan J. Effectiveness and safety of intravenous application of dexmedetomidine for cesarean section under general anesthesia: a meta-analysis of randomized trials. Drug design, development and therapy. 2019;13:965.
  13. Dodawad R, Sumalatha GB, Pandarpurkar S, Jajee P. Intrathecal midazolam as an adjuvant in pregnancy-induced hypertensive patients undergoing an elective caesarean section: A clinical comparative study. Anesthesiology and pain medicine. 2016 Oct;6(5).
  14. Roofthooft E, Joshi GP, Rawal N, Van de Velde M, PROSPECT Working Group of the European Society of Regional Anaesthesia and Pain Therapy and supported by the Obstetric Anaesthetists’ Association, Joshi GP, Pogatzki‐Zahn E, Van de Velde M, Schug S, Kehlet H, Bonnet F. PROSPECT guideline for elective caesarean section: updated systematic review and procedure‐specific postoperative pain management recommendations. Anaesthesia. 2021 May;76(5):665-80.
  15. Mowafy SM, El Sayed M. Comparative study between the effects of Nalbuphine, Propofol, and Ondansetron for control of intrathecal opioid induced pruritus in parturients after Cesarean Section: Randomized Controlled Trial. Zagazig University Medical Journal. 2020 Jun 1.
  16. Yaddanapudi S, Batra YK, Balagopal A, Nagdeve NG. Sedation in patients above 60 years of age undergoing urological surgery under spinal anesthesia: Comparison of propofol and midazolam infusions. Journal of Postgraduate Medicine 2007; 53(3):171.
  17. Patki A, Shelgaonkar VC. A comparison of equisedative infusions of propofol and midazolam for conscious sedation during spinal anesthesia-a prospective randomized study. Journal of anaesthesiology, clinical pharmacology 2011; 27(1):47-53.
  18. Khurana P, Agarwal A, Verma RK, Gupta PK. Comparison of midazolam and propofol for BIS-guided sedation during regional anaesthesia. Indian journal of anaesthesia 2009; 53(6):662.
  19. Basuni AS. Addition of low-dose ketamine to midazolam and low-dose bupivacaine improves hemodynamics and postoperative analgesia during spinal anesthesia for cesarean section. Journal of anaesthesiology, clinical pharmacology 2016; 32(1):44.
  20. Cheng YJ, Wang YP, Fan SZ, Liu CC. Intravenous infusion of low dose propofol for conscious sedation in cesarean section before spinal anesthesia. Acta Anaesthesiologica Sinica 1997; 35(2):79-84.
  21. Sajedi P, Yaraghi A, Bigi AA, Rezaie M, Mehrabi Kooshki A. Comparative Evaluation of Vital Signs Stability, Sedation and Analgesia Scores with Two Methods of Sedation: Propofol+ Fentanyl and Ketamine+ Fentanyl during Perm Cath Insertion. Research in Medicine 2010; 34(1):13-19.
  22. Frölich MA, Burchfield DJ, Euliano T, Caton D. A single dose of fentanyl and midazolam prior to Cesarean section have no adverse neontal effects. Canadian Journal of Anesthesia 2006; 53(1):79-85.
  23. Wilson E, Mackenzie N, Grant IS. A comparison of propofol and midazolam by infusion to provide sedation in patients who receive spinal anaesthesia. Anaesthesia 1988; 43:91-4.
  24. Kim DK, Joo Y, Sung TY, Kim SY, Shin HY. Dreaming in sedation during spinal anesthesia: a comparison of propofol and midazolam infusion. Anesthesia & Analgesia 2011; 112(5):1076-81.
  25. Yaddanapudi S, Batra YK, Balagopal A, Nagdeve NG. Sedation in patients above 60 years of age undergoing urological surgery under spinal anesthesia: Comparison of propofol and midazolam infusions. Journal of Postgraduate Medicine 2007; 53(3):171.
  26. Patki A, Shelgaonkar VC. A comparison of equisedative infusions of propofol and midazolam for conscious sedation during spinal anesthesia-a prospective randomized study. Journal of anaesthesiology, clinical pharmacology 2011; 27(1):47.
  27. Bagchi D, Mandal MC, Basu SR. Arousal time from sedation during spinal anaesthesia for elective infraumbilical surgeries: Comparison between propofol and midazolam. Indian journal of anaesthesia 2014; 58(4):403.
  28. Badrkhahan S. The comparison of propofol with thiopental on neonatal apgar during cesarean section. J Shahrekord Univ Med Sci. 2007; 9 (3) :10-14
  29. Valtonen M, Kanto J, Rosenberg P. Comparison of propofol and thiopentone for induction of anaesthesia for elective caesarean section. Anaesthesia 1989; 44(9):758-62.
  30. Li CH, Zhu CX, He J. Effects of general anesthesia for cesarean section on infants. Zhonghua fu chan ke za zhi 2006; 41(3):162-4.
  31. Imani FA, Mirdehghan MH, Entezary SR, Mehdizadeh Kashi A. Evaluation of Maternal and Neonatal Effects of Adding Midazolam to Bupivacaine under Combined Spinal-Epidural Anesthesia in Elective Cesarean Section. Razi Journal of Medical Sciences 2009; 15:27-36.
  32. Ghodraty M, Akhavan Akbari G, Amani F, Rahimi S, Shahab N. Comparing the Effect of Using Propofol and Thiopental in the Induction of Anesthesia on the Apgar Score of the Neonate and Hemodynamic State of Mothers during Cesarean Section. J Ardabil Univ Med Sci 2003; 3(3):52-58
  33. Zabetian H, Kalani N, Khalili A, Sahraei R, Radmehr M. Antiemetic Effects of Midazolam and Propofol during Spinal Anesthesia on Women Undergoing Elective Cesarean Sections. J Pain Manage Med. 2016;2(116):2.
  34. Karami A, Khademi S, Fattahi Saravi Z, Jouybar R, Esmaeilinezhad Z, Asadpour E. Comparison of Maternal and Neonatal Outcomes between Vaginal Delivery and Cesarean Section under General or spinal anesthesia-retrospective study. Iran J Obstet Gynecol Infertil 2020; 23(4):15-23.
  35. Pirhadi M, Valiani M, Azimi M. Effect of Auriculotherapy on Neonatal Apgar Score and Maternal Postpartum Hemorrhage and Vital Signs. Iran J Obstet Gynecol Infertil 2018; 21(6):27-33.
  36. Lotfalizadeh M, Alipour M, Gholami M, Shakeri MT. Comparative study of effect of general anesthesia with thiopental and propofol on APGAR score of neonate and uterine relaxation in cesarean section. Iran J Obstet Gynecol Infertil 2012; 15(26):1-7.