Clinical trial NCT06160583: General Anesthesia for Cesarean Section, Maternal and Perinatal Outcomes
Official title: General Anesthesia in Obstetric Patients for Cesarean Section, Maternal and Perinatal Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Perinatal Morbidity
Maternal-Fetal Relations
Keywords: General anesthesia
Materno
Perinatal
Outcomes
Cesarean
Lead sponsor: Hospital Civil de Guadalajara
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 5000
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obstetric patients who require cesarean section surgery at the Fray Antonio Alcalde Civil Hospital of Guadalajara

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Obstetric patients who enter the hospital intubated.

Primary outcomes:
measure: Frequency general anesthesia
timeFrame: 5 years
measure: Maternal and fetal diagnosis
timeFrame: 5 years
measure: Classification physical status
timeFrame: 5 years
measure: General anesthesia complications
timeFrame: 5 years
measure: Maternal condition at the end of surgery
timeFrame: 5 years
measure: Anesthetic induction
timeFrame: 5 years
measure: Prenatal classification by weight and gestational age
timeFrame: 5 years
measure: Apgar Score
timeFrame: 5 years
measure: Size at birth
timeFrame: 5 years
measure: Condition of the newborn
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Maria de Los Angeles Campechano Ascencio
state: Jalisco
Study officials:
affiliation: Hospital Civil de Guadalajara
name: Diego Francisco Gonzalez Peña, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Civil de Guadalajara
name: María de los Angeles Campechano Ascencio, MSc
role: STUDY_DIRECTOR
affiliation: Hospital Civil de Guadalajara
name: Jorge Bravo Rubio, PhD
role: STUDY_CHAIR
affiliation: Hospital Civil de Guadalajara
name: Ofelia Margarita Ascencio Aceves, MD
role: STUDY_CHAIR
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