Effect of Subarachnoid Hyperbaric Bupivacaine in Obese Pregnant Patients Undergoing Cesarean Section
Effect of Subarachnoid Hyperbaric Bupivacaine on Mean Arterial Pressure in Obese Pregnant Patients Undergoing Cesarean Section
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 4
Contacts and Locations
Study Contact
Study Contact
- Name: María de los Angeles Campechano Ascencio, MSc
- Phone Number: +5213310233983
- Email: angelescampechano@hotmail.com
Study Contact Backup
- Name: Miriam Mendez del Villar, PhD
- Phone Number: +5213310640220
- Email: miriamendez@hotmail.com
Study Locations
-
-
Jalisco
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Guadalajara, Jalisco, Mexico, 44280
- Recruiting
- Hospital Civil de Guadalajara
-
Contact:
- MARIA DE LOS ANGELES CAMPECHANO ASCENCIO, MSc
- Phone Number: 3310233983 +5213310233983
- Email: angelescampechano@hotmail.com
-
Contact:
- MIRIAM MENDEZ DEL VILLAR, MSc PhD
- Phone Number: +5213310640220
- Email: miriamendez@hotmail.com
-
Principal Investigator:
- MARIA DE LOS ANGELES CAMPECHANO-ASCENCIO, MSc
-
Sub-Investigator:
- MIRIAM MENDEZ-DEL VILLAR, MSc PhD
-
Sub-Investigator:
- LEONEL GARCIA-BENAVIDES, MSc PhD
-
Sub-Investigator:
- JORGE BRAVO-RUBIO, MSc
-
Sub-Investigator:
- EDY DAVID RUBIO-ARELLANO, MSc
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pregnancy ≥37 weeks gestation with single fetus
- Body mass index (BMI) ≥ 30 kg/m2
- Indication of termination of pregnancy via abdominal caesarean section
- Indication of subarachnoid neuraxial block under mixed technique
- Signing of consent under information
Exclusion Criteria:
- Allergy to local anesthetics
- Psychiatric treatment (antidepressants, anxiolytics, antipsychotics)
- Addiction to any type of drug
- Liver, renal, pulmonary or cardiac disease
- High blood pressure
- Type I, II and gestational diabetes
- Diagnostic of non-calming fetal state
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: 5mg bupivacaine
Anesthetic technique, the patient receives subarachnoid hyperbaric bupivacaine at a dose of 5mg
|
Anesthetic technique, the patient receives subarachnoid hyperbaric bupivacaine at a dose of 5mg
Other Names:
|
|
Experimental: 10mg bupivacaine
Anesthetic technique, the patient receives subarachnoid hyperbaric bupivacaine at a dose of 10mg
|
Anesthetic technique, the patient receives subarachnoid hyperbaric bupivacaine at a dose of 10 mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess the mean blood pressure
Time Frame: 3 hour
|
Number of pregnant patients with obesity who present a decrease in mean arterial pressure after the administration of subarachnoid hyperbaric bupivacaine with doses of 5mg and 10mg during cesarean surgery
|
3 hour
|
|
Determine the effects on the heart rate
Time Frame: 3 hour
|
Number of pregnant patients with obesity who present changes in heart rate such as bradycardia (heart rate less than 60 beats minute) or tachycardia (heart rate greater than 120 beats minute) after administration of subarachnoid hyperbaric bupivacaine with doses of 5mg and 10 mg during cesarean surgery
|
3 hour
|
|
Determine the effects on the O2 saturation
Time Frame: 3 hour
|
Number of pregnant patients with obesity who present changes in O2 saturation after administration of subarachnoid hyperbaric bupivacaine with doses of 5mg and 10mg during cesarean surgery
|
3 hour
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Document the Apgar score
Time Frame: 5 minutes
|
Document the Apgar score in the newborn.
(Apgar Score evaluate five sign: color, heart rate, reflex irritability, muscle tone and respiration) The score ranges from 0 to 2 per sign according to the criteria of the neonatologist, to grant a maximum score of 10 points.
A grade of less than 7 points is considered low Apgar scores.
This scores is registered t minute and five minutes of life.
|
5 minutes
|
|
Describe the adverse effects (nausea or vomiting)
Time Frame: 3 hour
|
Number of pregnant patients with obesity with side effects such as nausea or vomiting after administration of subarachnoid hyperbaric bupivacaine with doses of 5mg and 10 mg during cesarean surgery
|
3 hour
|
|
Identify the level of sensory blockade
Time Frame: 15 minutes
|
Number of pregnant patients with obesity with adequate sensory block (thoracic dermatome 4 is defined as adequate to begin the surgical technique), the level of sensory block reached after the administration of subarachnoid hyperbaric bupivacaine with doses of 5mg and 10mg.
The sensory block was evaluated using pinprick.
Every 3 minutes the first 15 minutes after the subarachnoid block.
|
15 minutes
|
|
Describe the adverse effects on the fetus
Time Frame: 1 hour
|
Number of pregnant patients with obesity with any side effect associated with the fetal bradycardia anesthetic technique (Fetal heart rate less than 120 beats minute) cardiac arrest (Fetal heart rate less than 100 beats minute) And in the newborn fetal acidosis (umbilical vein gasometry with Hydrogen Potential (pH) <7.0 or excess bases >-12 mmol/L)
|
1 hour
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: María de los Angeles Campechano Ascencio, MSc, Hospital Civil de Guadalajara
- Study Director: Miriam Mendez del Villar, PhD, Universidad de Guadalajara Centro Universitario de Tonalá
- Study Chair: Leonel Garcia Benavides, PhD, Universidad de Guadalajara Centro Universitario de Tonalá
- Study Chair: Jorge Bravo Rubio, MSc, Hospital Civil de Guadalajara
- Study Chair: Edy David Rubio Arellano, MSc, Universidad de Guadalajara Centro Universitario Ciencias de la Salud
Publications and helpful links
General Publications
- Tonidandel A, Booth J, D'Angelo R, Harris L, Tonidandel S. Anesthetic and obstetric outcomes in morbidly obese parturients: a 20-year follow-up retrospective cohort study. Int J Obstet Anesth. 2014 Nov;23(4):357-64. doi: 10.1016/j.ijoa.2014.05.004. Epub 2014 Jun 4. Erratum In: Int J Obstet Anesth. 2015 Feb;24(1):96.
- Ouzounian JG, Elkayam U. Physiologic changes during normal pregnancy and delivery. Cardiol Clin. 2012 Aug;30(3):317-29. doi: 10.1016/j.ccl.2012.05.004. Epub 2012 Jun 20.
- Hood DD, Dewan DM. Anesthetic and obstetric outcome in morbidly obese parturients. Anesthesiology. 1993 Dec;79(6):1210-8. doi: 10.1097/00000542-199312000-00011.
- Tan T, Sia AT. Anesthesia considerations in the obese gravida. Semin Perinatol. 2011 Dec;35(6):350-5. doi: 10.1053/j.semperi.2011.05.021.
- Ngan Kee WD, Khaw KS, Tan PE, Ng FF, Karmakar MK. Placental transfer and fetal metabolic effects of phenylephrine and ephedrine during spinal anesthesia for cesarean delivery. Anesthesiology. 2009 Sep;111(3):506-12. doi: 10.1097/ALN.0b013e3181b160a3.
- Lee Y, Balki M, Parkes R, Carvalho JC. Dose requirement of intrathecal bupivacaine for cesarean delivery is similar in obese and normal weight women. Rev Bras Anestesiol. 2009 Nov-Dec;59(6):674-83. doi: 10.1016/s0034-7094(09)70092-3. English, Portuguese.
- Carvalho B, Collins J, Drover DR, Atkinson Ralls L, Riley ET. ED(50) and ED(95) of intrathecal bupivacaine in morbidly obese patients undergoing cesarean delivery. Anesthesiology. 2011 Mar;114(3):529-35. doi: 10.1097/ALN.0b013e318209a92d.
- Ring LE. The anesthetic approach to operative delivery of the extremely obese parturient. Semin Perinatol. 2014 Oct;38(6):341-8. doi: 10.1053/j.semperi.2014.07.008. Epub 2014 Aug 19.
- Badve MH, Golfeiz C, Vallejo MC. Anesthetic considerations for the morbid obese parturient. Int Anesthesiol Clin. 2014 Summer;52(3):132-47. doi: 10.1097/AIA.0000000000000024. No abstract available.
- Lamon AM, Habib AS. Managing anesthesia for cesarean section in obese patients: current perspectives. Local Reg Anesth. 2016 Aug 16;9:45-57. doi: 10.2147/LRA.S64279. eCollection 2016.
- Dennis AT, Castro JM, Ong M, Carr C. Haemodynamics in obese pregnant women. Int J Obstet Anesth. 2012 Apr;21(2):129-34. doi: 10.1016/j.ijoa.2011.11.007. Epub 2012 Feb 11.
- Rodrigues FR, Brandao MJ. Regional anesthesia for cesarean section in obese pregnant women: a retrospective study. Rev Bras Anestesiol. 2011 Jan-Feb;61(1):13-20. doi: 10.1016/S0034-7094(11)70002-2.
- Wise RA, Polito AJ, Krishnan V. Respiratory physiologic changes in pregnancy. Immunol Allergy Clin North Am. 2006 Feb;26(1):1-12. doi: 10.1016/j.iac.2005.10.004.
- Chandra S, Tripathi AK, Mishra S, Amzarul M, Vaish AK. Physiological changes in hematological parameters during pregnancy. Indian J Hematol Blood Transfus. 2012 Sep;28(3):144-6. doi: 10.1007/s12288-012-0175-6. Epub 2012 Jul 15.
- American College of Obstetricians and Gynecologists. ACOG Committee opinion no. 549: obesity in pregnancy. Obstet Gynecol. 2013 Jan;121(1):213-7. doi: 10.1097/01.aog.0000425667.10377.60.
- Soens MA, Birnbach DJ, Ranasinghe JS, van Zundert A. Obstetric anesthesia for the obese and morbidly obese patient: an ounce of prevention is worth more than a pound of treatment. Acta Anaesthesiol Scand. 2008 Jan;52(1):6-19. doi: 10.1111/j.1399-6576.2007.01483.x.
- Gaiser R. Anesthetic Considerations in the Obese Parturient. Clin Obstet Gynecol. 2016 Mar;59(1):193-203. doi: 10.1097/GRF.0000000000000180.
- Nani FS, Torres ML. Correlation between the body mass index (BMI) of pregnant women and the development of hypotension after spinal anesthesia for cesarean section. Rev Bras Anestesiol. 2011 Jan-Feb;61(1):21-30. doi: 10.1016/S0034-7094(11)70003-4.
- Klohr S, Roth R, Hofmann T, Rossaint R, Heesen M. Definitions of hypotension after spinal anaesthesia for caesarean section: literature search and application to parturients. Acta Anaesthesiol Scand. 2010 Sep;54(8):909-21. doi: 10.1111/j.1399-6576.2010.02239.x. Epub 2010 Apr 23.
- Rasolonjatovo TY, Ravololonirina BM, Randriamanantany ZA, Raveloson NE. [Spinal anesthesia for cesarean section: risk factors for emergence of Apgar scores below 7 in Malagasy newborns]. Pan Afr Med J. 2014 Oct 23;19:193. doi: 10.11604/pamj.2014.19.193.3392. eCollection 2014. French.
- Mercier FJ, Auge M, Hoffmann C, Fischer C, Le Gouez A. Maternal hypotension during spinal anesthesia for caesarean delivery. Minerva Anestesiol. 2013 Jan;79(1):62-73. Epub 2012 Nov 18.
- Polin CM, Hale B, Mauritz AA, Habib AS, Jones CA, Strouch ZY, Dominguez JE. Anesthetic management of super-morbidly obese parturients for cesarean delivery with a double neuraxial catheter technique: a case series. Int J Obstet Anesth. 2015 Aug;24(3):276-80. doi: 10.1016/j.ijoa.2015.04.001. Epub 2015 Apr 8.
- Sng BL, Siddiqui FJ, Leong WL, Assam PN, Chan ES, Tan KH, Sia AT. Hyperbaric versus isobaric bupivacaine for spinal anaesthesia for caesarean section. Cochrane Database Syst Rev. 2016 Sep 15;9(9):CD005143. doi: 10.1002/14651858.CD005143.pub3.
- Hollowell J, Pillas D, Rowe R, Linsell L, Knight M, Brocklehurst P. The impact of maternal obesity on intrapartum outcomes in otherwise low risk women: secondary analysis of the Birthplace national prospective cohort study. BJOG. 2014 Feb;121(3):343-55. doi: 10.1111/1471-0528.12437. Epub 2013 Sep 11.
- Zhu T, Tang J, Zhao F, Qu Y, Mu D. Association between maternal obesity and offspring Apgar score or cord pH: a systematic review and meta-analysis. Sci Rep. 2015 Dec 22;5:18386. doi: 10.1038/srep18386.
- Edwards RK, Cantu J, Cliver S, Biggio JR Jr, Owen J, Tita ATN. The association of maternal obesity with fetal pH and base deficit at cesarean delivery. Obstet Gynecol. 2013 Aug;122(2 Pt 1):262-267. doi: 10.1097/AOG.0b013e31829b1e62.
- Reyes M, Pan PH. Very low-dose spinal anesthesia for cesarean section in a morbidly obese preeclamptic patient and its potential implications. Int J Obstet Anesth. 2004 Apr;13(2):99-102. doi: 10.1016/j.ijoa.2003.09.004.
- Bamgbade OA, Khalaf WM, Ajai O, Sharma R, Chidambaram V, Madhavan G. Obstetric anaesthesia outcome in obese and non-obese parturients undergoing caesarean delivery: an observational study. Int J Obstet Anesth. 2009 Jul;18(3):221-5. doi: 10.1016/j.ijoa.2008.07.013. Epub 2009 May 17.
- Ngaka TC, Coetzee JF, Dyer RA. The Influence of Body Mass Index on Sensorimotor Block and Vasopressor Requirement During Spinal Anesthesia for Elective Cesarean Delivery. Anesth Analg. 2016 Dec;123(6):1527-1534. doi: 10.1213/ANE.0000000000001568.
- Eltzschig HK, Lieberman ES, Camann WR. Regional anesthesia and analgesia for labor and delivery. N Engl J Med. 2003 Jan 23;348(4):319-32. doi: 10.1056/NEJMra021276. No abstract available.
- Teoh WH, Thomas E, Tan HM. Ultra-low dose combined spinal-epidural anesthesia with intrathecal bupivacaine 3.75 mg for cesarean delivery: a randomized controlled trial. Int J Obstet Anesth. 2006 Oct;15(4):273-8. doi: 10.1016/j.ijoa.2006.03.004. Epub 2006 Jun 13.
- Hassanin AS, El-Shahawy HF, Hussain SH, Bahaa Eldin AM, Elhawary MM, Elbakery M, Elsafty MSE. Impact of interval between induction of spinal anesthesia to delivery on umbilical arterial cord ph of neonates delivered by elective cesarean section. BMC Pregnancy Childbirth. 2022 Mar 17;22(1):216. doi: 10.1186/s12884-022-04536-y.
- Kominiarek MA, Chauhan SP. Obesity Before, During, and After Pregnancy: A Review and Comparison of Five National Guidelines. Am J Perinatol. 2016 Apr;33(5):433-41. doi: 10.1055/s-0035-1567856. Epub 2015 Nov 20.
- Silva JC, Amaral AR, Ferreira BD, Petry JF, Silva MR, Krelling PC. [Obesity during pregnancy: gestational complications and birth outcomes.]. Rev Bras Ginecol Obstet. 2014 Nov;36(11):509-513. doi: 10.1590/s0100-720320140005024. Epub 2014 Nov 1. Portuguese.
- Kim ST. Anesthetic management of obese and morbidly obese parturients. Anesth Pain Med (Seoul). 2021 Oct;16(4):313-321. doi: 10.17085/apm.21090. Epub 2021 Oct 29.
- Arias J, Lacassie HJ. [Prophylaxis and treatment of arterial hypotension during caesarean with spinal anaesthesia]. Rev Esp Anestesiol Reanim. 2013 Nov;60(9):511-8. doi: 10.1016/j.redar.2012.07.023. Epub 2012 Oct 23. Spanish.
- Davies GAL, Maxwell C, McLeod L. No. 239-Obesity in Pregnancy. J Obstet Gynaecol Can. 2018 Aug;40(8):e630-e639. doi: 10.1016/j.jogc.2018.05.018.
- Lamon AM, Einhorn LM, Cooter M, Habib AS. The impact of body mass index on the risk of high spinal block in parturients undergoing cesarean delivery: a retrospective cohort study. J Anesth. 2017 Aug;31(4):552-558. doi: 10.1007/s00540-017-2352-0. Epub 2017 Apr 18.
- Committee Membership:; Burns S, Biering-Sorensen F, Donovan W, Graves DE, Jha A, Johansen M, Jones L, Krassioukov A, Kirshblum S, Mulcahey MJ, Read MS, Waring W. International standards for neurological classification of spinal cord injury, revised 2011. Top Spinal Cord Inj Rehabil. 2012 Winter;18(1):85-99. doi: 10.1310/sci1801-85. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 168/23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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