AnesthesiaNCT06160583
General Anesthesia for Cesarean Section, Maternal and Perinatal Outcomes
An observational study of Anesthesia and Perinatal Morbidity, run by Hospital Civil de Guadalajara at 1 site in Mexico.
Trial 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 more about this study
- Who is it for?
- Ages 14 to 45 years, women only
- Conditions the study is for
- Anesthesia, Perinatal Morbidity, Maternal-Fetal Relations
- How many people
- 5,000 participants
- Where
- 1 siteMexico
- Study dates
- 12 Nov 2023to 31 Jan 2024
- How long will I take part?
- 5 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Obstetric patients who require cesarean section surgery at the Fray Antonio Alcalde Civil Hospital of Guadalajara
Who may be able to join
- Obstetric patients who require surgical intervention to resolve the pregnancy, under general anesthesia
Who cannot join
- Obstetric patients who enter the hospital intubated.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Maria de Los Angeles Campechano Ascencio
Guadalajara, Jalisco, 44100
About this study
Official title: General Anesthesia in Obstetric Patients for Cesarean Section, Maternal and Perinatal Outcomes
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.
- Conditions
- Anesthesia, Perinatal Morbidity, Maternal-Fetal Relations
- Keywords
- General anesthesia, Materno, Perinatal, Outcomes, Cesarean
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency general anesthesia
Obtain the frequency of obstetric patients undergoing cesarean section surgery under general anesthesia
Measured: 5 years
Maternal and fetal diagnosis
Specify the diagnoses for which general anesthesia is carried out
Measured: 5 years
Classification physical status
Know the physical status of patients undergoing cesarean surgery
Measured: 5 years
General anesthesia complications
Identify complications of the anesthetic technique
Measured: 5 years
Maternal condition at the end of surgery
List the maternal discharge condition at the end of surgery (intubated/extubated)
Measured: 5 years
Anesthetic induction
Describe the medications used for anesthetic induction
Measured: 5 years
Prenatal classification by weight and gestational age
Document prenatal classification of the fetus by weight and gestational age assigned by ultrasound
Measured: 5 years
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
Measured: 5 years
Size at birth
Document birth size classification assigned by neonatology
Measured: 5 years
Condition of the newborn
List the condition of the newborn after his or her initial evaluation (rooming-in/neonatal therapy)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start12 Nov 2023
- Primary completion12 Nov 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (52)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 5,000 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Hospital Civil de Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Francisco Gonzalez Pena, Hospital Civil de Guadalajara
- Investigators
- Diego Francisco Gonzalez Peña, MD, Principal investigator, Hospital Civil de GuadalajaraMaría de los Angeles Campechano Ascencio, MSc, Study director, Hospital Civil de GuadalajaraJorge Bravo Rubio, PhD, Study chair, Hospital Civil de GuadalajaraOfelia Margarita Ascencio Aceves, MD, Study chair, Hospital Civil de Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160583
- Sponsor's protocol ID
- 257/23
- Status last verified
- Oct 2024
- First submitted
- 29 Nov 2023
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The records collected will be used exclusively for the results of this protocol
Publications
Mhyre JM, Sultan P. General Anesthesia for Cesarean Delivery: Occasionally Essential but Best Avoided. Anesthesiology. 2019 Jun;130(6):864-866. doi: 10.1097/ALN.0000000000002708. No abstract available.
PubMed 30985305Ikeda 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 32404093Kodali 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 18292672Robbins 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 33121885Bowring 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 16846870Lumbiganon 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 32576845Metogo 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 33663391Swanson 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 34844279Ozden 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 37829746Devroe 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 25827280Neef 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 37832560Munro 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 37932651Mushambi 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 26449292Munnur 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.
PubMed 16215346Jain 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