CClinicalTrials.gg
CompletedNCT06160583Updated Oct 22, 2024

General Anesthesia for Cesarean Section, Maternal and Perinatal Outcomes

An observational study in Anesthesia, Perinatal Morbidity and Maternal-Fetal Relations, sponsored by Hospital Civil de Guadalajara. Completed at 1 site in Mexico. Open to female participants aged 14 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-10-22.

Sponsored by Hospital Civil de Guadalajara · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
5,000
Ages
14 Years to 45 Years
Sex
Female
01

Study summary

To evaluate the maternal and perinatal outcomes that occur in obstetric patients undergoing cesarean section surgery under general anesthesia at the Fray Antonio Alcalde Civil Hospital of Guadalajara.

Read the detailed description

Pregnant patients who required surgical management to resolve the pregnancy via the abdominal route will be identified from the anesthesiology logs and evaluation sheets of the obstetric patient. During the period from January 2019 to December 2023.

The data will be collected in a database made up of Excel software. Maternal data collected:Of the total cesarean surgery procedures, the following are collected: hospital record, the anesthetic technique administered and the date of the surgical intervention.

Patients who underwent surgery under general anesthesia technique will be identified and their demographic data will be recorded (name, age, hospital record, weight, height, BMI, obstetric data, number of pregnancies, births, cesarean sections, abortions, weeks of gestation) diagnosis. , type of intervention, procedure performed The characteristics of the anesthetic technique, the drugs used for anesthetic induction, will also be recorded.

Complications associated with the anesthetic technique will be recorded, such as: intraoperative awakening, failed tracheal intubation and pulmonary aspiration.

The status of the patient's discharge from the operating room, extubated or intubated, will be recorded.

Fetal data collected: Prenatal fetal diagnosis will be obtained, as well as its classification by ultrasound measurement of estimated weight and weeks of gestation assigned to weight appropriate for gestational age, small for gestational age or large for gestational age.

From the results of the newborn, the condition at birth, weight, height, gestational age, as well as the size at birth assigned in: adequate weight, low or high, are recorded.

The Apgar score will be obtained at one minute and at 5 minutes. The condition of the newborn after immediate care will be recorded if he or she remains in rooming-in or is discharged to surveillance, intermediate or intensive therapy.

Data that is not found in the obstetric patient's evaluation sheets will be corroborated in anesthesiology, nursing, neonatology logs and electronic records. Once the database is obtained, the statistical analysis will be carried out.

02

Conditions studied

  • Anesthesia
  • Perinatal Morbidity
  • Maternal-Fetal Relations

Keywords

  • General anesthesia
  • Materno
  • Perinatal
  • Outcomes
  • Cesarean
03

In context

Lead sponsor

Hospital Civil de Guadalajara is the lead sponsor of 39 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Obstetric patients who require cesarean section surgery at the Fray Antonio Alcalde Civil Hospital of Guadalajara

Inclusion criteria

  • Obstetric patients who require surgical intervention to resolve the pregnancy, under general anesthesia

Exclusion criteria

Exclusion Criteria:

  • Obstetric patients who enter the hospital intubated.
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
5,000 participants (actual)
Target follow-up
5 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Frequency general anesthesia

    Obtain the frequency of obstetric patients undergoing cesarean section surgery under general anesthesia

    Time frame: 5 years

  2. Maternal and fetal diagnosis

    Specify the diagnoses for which general anesthesia is carried out

    Time frame: 5 years

  3. Classification physical status

    Know the physical status of patients undergoing cesarean surgery

    Time frame: 5 years

  4. General anesthesia complications

    Identify complications of the anesthetic technique

    Time frame: 5 years

  5. Maternal condition at the end of surgery

    List the maternal discharge condition at the end of surgery (intubated/extubated)

    Time frame: 5 years

  6. Anesthetic induction

    Describe the medications used for anesthetic induction

    Time frame: 5 years

  7. Prenatal classification by weight and gestational age

    Document prenatal classification of the fetus by weight and gestational age assigned by ultrasound

    Time frame: 5 years

  8. Apgar Score

    Record the newborn's Apgar score Apgar scale It evaluates a score from 0 to 10, the higher the score, the better the baby's progress. a score greater than 7 is considered normal

    Time frame: 5 years

  9. Size at birth

    Document birth size classification assigned by neonatology

    Time frame: 5 years

  10. Condition of the newborn

    List the condition of the newborn after his or her initial evaluation (rooming-in/neonatal therapy)

    Time frame: 5 years

07

Study locations

1 site
  • Maria de Los Angeles Campechano Ascencio
    Guadalajara, Jalisco 44100, Mexico
08

References and documents

Publications

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  • Ikeda T, Kato A, Bougaki M, Araki Y, Ohata T, Kawashima S, Imai Y, Ninagawa J, Oba K, Chang K, Uchida K, Yamada Y. A retrospective review of 10-year trends in general anesthesia for cesarean delivery at a university hospital: the impact of a newly launched team on obstetric anesthesia practice. BMC Health Serv Res. 2020 May 13;20(1):421. doi: 10.1186/s12913-020-05314-2. PubMed 32404093 ↗
  • Kodali BS, Chandrasekhar S, Bulich LN, Topulos GP, Datta S. Airway changes during labor and delivery. Anesthesiology. 2008 Mar;108(3):357-62. doi: 10.1097/ALN.0b013e31816452d3. PubMed 18292672 ↗
  • Robbins LS, Blanchard CT, Biasini FJ, Powell MF, Casey BM, Tita AT, Harper LM. General anesthesia for cesarean delivery and childhood neurodevelopmental and perinatal outcomes: a secondary analysis of a randomized controlled trial. Int J Obstet Anesth. 2021 Feb;45:34-40. doi: 10.1016/j.ijoa.2020.08.007. Epub 2020 Aug 25. PubMed 33121885 ↗
  • Bowring J, Fraser N, Vause S, Heazell AE. Is regional anaesthesia better than general anaesthesia for caesarean section? J Obstet Gynaecol. 2006 Jul;26(5):433-4. doi: 10.1080/01443610600720345. PubMed 16846870 ↗
  • Lumbiganon P, Moe H, Kamsa-Ard S, Rattanakanokchai S, Laopaiboon M, Kietpeerakool C, Jampathong N, Somjit M, Cecatti JG, Vogel JP, Betran AP, Mittal S, Torloni MR. Outcomes associated with anaesthetic techniques for caesarean section in low- and middle-income countries: a secondary analysis of WHO surveys. Sci Rep. 2020 Jun 23;10(1):10176. doi: 10.1038/s41598-020-66897-8. PubMed 32576845 ↗
  • Metogo JAM, Nana TN, Ngongheh BA, Nyuydzefon EB, Adjahoung CA, Tochie JN, Minkande JZ. General versus regional anaesthesia for caesarean section indicated for acute foetal distress: a retrospective cohort study. BMC Anesthesiol. 2021 Mar 4;21(1):68. doi: 10.1186/s12871-021-01289-7. PubMed 33663391 ↗
  • Swanson K, Liang L, Grobman WA, Higgins N, Roy A, Son M. Duration of Exposure to General Endotracheal Anesthesia during Cesarean Deliveries at Term and Perinatal Complications. Am J Perinatol. 2022 Feb;39(3):232-237. doi: 10.1055/s-0041-1739355. Epub 2021 Nov 29. PubMed 34844279 ↗
  • Ozden MGN, Koruk S, Collak Z, Panik N. Comparison of the effects of general and spinal anesthesia for cesarean delivery on maternal and fetal outcomes: A retrospective analysis of data. North Clin Istanb. 2023 Sep 11;10(5):575-582. doi: 10.14744/nci.2023.25593. eCollection 2023. PubMed 37829746 ↗
  • Devroe S, Van de Velde M, Rex S. General anesthesia for caesarean section. Curr Opin Anaesthesiol. 2015 Jun;28(3):240-6. doi: 10.1097/ACO.0000000000000185. PubMed 25827280 ↗
  • Neef V, Wenk M, Kranke P. [Obstetric Anesthesia]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2023 Oct;58(10):570-582. doi: 10.1055/a-2043-4329. Epub 2023 Oct 13. German. PubMed 37832560 ↗
  • Munro A, Sjaus A. General anesthesia for Cesarean delivery: can interinstitutional variation in practice offer deeper insights into our choice of anesthetic modality? Can J Anaesth. 2024 Feb;71(2):169-174. doi: 10.1007/s12630-023-02634-9. Epub 2023 Nov 6. No abstract available. PubMed 37932651 ↗
  • Mushambi MC, Kinsella SM, Popat M, Swales H, Ramaswamy KK, Winton AL, Quinn AC; Obstetric Anaesthetists' Association; Difficult Airway Society. Obstetric Anaesthetists' Association and Difficult Airway Society guidelines for the management of difficult and failed tracheal intubation in obstetrics. Anaesthesia. 2015 Nov;70(11):1286-306. doi: 10.1111/anae.13260. PubMed 26449292 ↗
  • Munnur U, de Boisblanc B, Suresh MS. Airway problems in pregnancy. Crit Care Med. 2005 Oct;33(10 Suppl):S259-68. doi: 10.1097/01.ccm.0000183502.45419.c9. Erratum In: Crit Care Med. 2006 Jan;34(1):273. PubMed 16215346 ↗
  • Jain K, Gupta N, Yadav M, Thulkar S, Bhatnagar S. Radiological evaluation of airway - What an anaesthesiologist needs to know! Indian J Anaesth. 2019 Apr;63(4):257-264. doi: 10.4103/ija.IJA_488_18. PubMed 31000888 ↗
  • 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. PubMed 16443140 ↗
  • Dallmann A, Ince I, Meyer M, Willmann S, Eissing T, Hempel G. Gestation-Specific Changes in the Anatomy and Physiology of Healthy Pregnant Women: An Extended Repository of Model Parameters for Physiologically Based Pharmacokinetic Modeling in Pregnancy. Clin Pharmacokinet. 2017 Nov;56(11):1303-1330. doi: 10.1007/s40262-017-0539-z. PubMed 28401479 ↗
  • Sanghavi M, Rutherford JD. Cardiovascular physiology of pregnancy. Circulation. 2014 Sep 16;130(12):1003-8. doi: 10.1161/CIRCULATIONAHA.114.009029. No abstract available. PubMed 25223771 ↗
  • Sung S, Mikes BA, Martingano DJ, Mahdy H. Cesarean Delivery. 2024 Dec 7. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK546707/ PubMed 31536313 ↗
  • Cobb BT, Lane-Fall MB, Month RC, Onuoha OC, Srinivas SK, Neuman MD. Anesthesiologist Specialization and Use of General Anesthesia for Cesarean Delivery. Anesthesiology. 2019 Feb;130(2):237-246. doi: 10.1097/ALN.0000000000002534. PubMed 30601216 ↗
  • Dahlke JD, Mendez-Figueroa H, Rouse DJ, Berghella V, Baxter JK, Chauhan SP. Evidence-based surgery for cesarean delivery: an updated systematic review. Am J Obstet Gynecol. 2013 Oct;209(4):294-306. doi: 10.1016/j.ajog.2013.02.043. Epub 2013 Mar 1. PubMed 23467047 ↗
  • Betran AP, Ye J, Moller AB, Zhang J, Gulmezoglu AM, Torloni MR. The Increasing Trend in Caesarean Section Rates: Global, Regional and National Estimates: 1990-2014. PLoS One. 2016 Feb 5;11(2):e0148343. doi: 10.1371/journal.pone.0148343. eCollection 2016. PubMed 26849801 ↗
  • Al Rifai RH. Trend of caesarean deliveries in Egypt and its associated factors: evidence from national surveys, 2005-2014. BMC Pregnancy Childbirth. 2017 Dec 13;17(1):417. doi: 10.1186/s12884-017-1591-2. PubMed 29237410 ↗
  • Butwick AJ, Palanisamy A. Mode of anaesthesia for Caesarean delivery and maternal morbidity: can we overcome confounding by indication? Br J Anaesth. 2018 Apr;120(4):621-623. doi: 10.1016/j.bja.2018.01.002. Epub 2018 Feb 14. No abstract available. PubMed 29576102 ↗
  • Elnakib S, Abdel-Tawab N, Orbay D, Hassanein N. Medical and non-medical reasons for cesarean section delivery in Egypt: a hospital-based retrospective study. BMC Pregnancy Childbirth. 2019 Nov 8;19(1):411. doi: 10.1186/s12884-019-2558-2. PubMed 31703638 ↗
  • Schatz M, Dombrowski MP. Clinical practice. Asthma in pregnancy. N Engl J Med. 2009 Apr 30;360(18):1862-9. doi: 10.1056/NEJMcp0809942. No abstract available. PubMed 19403904 ↗
  • Bonhomme V, Staquet C, Montupil J, Defresne A, Kirsch M, Martial C, Vanhaudenhuyse A, Chatelle C, Larroque SK, Raimondo F, Demertzi A, Bodart O, Laureys S, Gosseries O. General Anesthesia: A Probe to Explore Consciousness. Front Syst Neurosci. 2019 Aug 14;13:36. doi: 10.3389/fnsys.2019.00036. eCollection 2019. PubMed 31474839 ↗
  • Siddik-Sayyid S, Zbeidy R. Practice guidelines for obstetric anesthesia--a summary. Middle East J Anaesthesiol. 2008 Oct;19(6):1291-303. No abstract available. PubMed 18942244 ↗
  • Franks NP. General anaesthesia: from molecular targets to neuronal pathways of sleep and arousal. Nat Rev Neurosci. 2008 May;9(5):370-86. doi: 10.1038/nrn2372. PubMed 18425091 ↗
  • McGuire B, Lucas DN. Planning the obstetric airway. Anaesthesia. 2020 Jul;75(7):852-855. doi: 10.1111/anae.14987. Epub 2020 Mar 6. No abstract available. PubMed 32144754 ↗
  • Juang J, Gabriel RA, Dutton RP, Palanisamy A, Urman RD. Choice of Anesthesia for Cesarean Delivery: An Analysis of the National Anesthesia Clinical Outcomes Registry. Anesth Analg. 2017 Jun;124(6):1914-1917. doi: 10.1213/ANE.0000000000001677. PubMed 28098588 ↗
  • Ring L, Landau R, Delgado C. The Current Role of General Anesthesia for Cesarean Delivery. Curr Anesthesiol Rep. 2021;11(1):18-27. doi: 10.1007/s40140-021-00437-6. Epub 2021 Feb 24. PubMed 33642943 ↗
  • Husarova V, McCaul CL. Incidence of general anaesthesia for caesarean section in parturients from different geographic regions: 7-year retrospective study in a single European university centre. Eur J Anaesthesiol. 2016 Jun;33(6):466-8. doi: 10.1097/EJA.0000000000000396. No abstract available. PubMed 26840830 ↗
  • Al-Husban N, Elmuhtaseb MS, Al-Husban H, Nabhan M, Abuhalaweh H, Alkhatib YM, Yousef M, Aloran B, Elyyan Y, Alghazo A. Anesthesia for Cesarean Section: Retrospective Comparative Study. Int J Womens Health. 2021 Feb 2;13:141-152. doi: 10.2147/IJWH.S292434. eCollection 2021. PubMed 33564269 ↗
  • Detsky ME, Jivraj N, Adhikari NK, Friedrich JO, Pinto R, Simel DL, Wijeysundera DN, Scales DC. Will This Patient Be Difficult to Intubate?: The Rational Clinical Examination Systematic Review. JAMA. 2019 Feb 5;321(5):493-503. doi: 10.1001/jama.2018.21413. Erratum In: JAMA. 2020 Mar 24;323(12):1194. doi: 10.1001/jama.2020.2069. PubMed 30721300 ↗
  • Preston R, Jee R. Obstetric airway management. Int Anesthesiol Clin. 2014 Spring;52(2):1-28. doi: 10.1097/AIA.0000000000000014. No abstract available. PubMed 24667446 ↗
  • Sumikura H, Niwa H, Sato M, Nakamoto T, Asai T, Hagihira S. Rethinking general anesthesia for cesarean section. J Anesth. 2016 Apr;30(2):268-73. doi: 10.1007/s00540-015-2099-4. Epub 2015 Nov 19. PubMed 26585767 ↗
  • Sajayan A, Wicker J, Ungureanu N, Mendonca C, Kimani PK. Current practice of rapid sequence induction of anaesthesia in the UK - a national survey. Br J Anaesth. 2016 Sep;117 Suppl 1:i69-i74. doi: 10.1093/bja/aew017. Epub 2016 Feb 24. PubMed 26917599 ↗
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  • Maronge L, Bogod D. Complications in obstetric anaesthesia. Anaesthesia. 2018 Jan;73 Suppl 1:61-66. doi: 10.1111/anae.14141. PubMed 29313912 ↗
  • Guglielminotti J, Landau R, Li G. Adverse Events and Factors Associated with Potentially Avoidable Use of General Anesthesia in Cesarean Deliveries. Anesthesiology. 2019 Jun;130(6):912-922. doi: 10.1097/ALN.0000000000002629. PubMed 30789362 ↗
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Individual participant data

Plan to share: No — The records collected will be used exclusively for the results of this protocol

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06160583
Lead sponsor
Hospital Civil de Guadalajara
Responsible party
Diego Francisco Gonzalez Pena (Anestesiologist, Hospital Civil de Guadalajara) — Principal investigator
First posted
Dec 7, 2023
Start date
Nov 12, 2023
Primary completion
Nov 12, 2023
Completion
Jan 31, 2024
Last update
Oct 22, 2024

Study contacts

Diego Francisco Gonzalez Peña, MD
principal investigator · Hospital Civil de Guadalajara
María de los Angeles Campechano Ascencio, MSc
study director · Hospital Civil de Guadalajara
Jorge Bravo Rubio, PhD
study chair · Hospital Civil de Guadalajara
Ofelia Margarita Ascencio Aceves, MD
study chair · Hospital Civil de Guadalajara

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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