General Anesthesia for Cesarean Section, Maternal and Perinatal Outcomes

Anesthesia Clinical Trial

Official title:

General Anesthesia in Obstetric Patients for Cesarean Section, Maternal and Perinatal Outcomes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06160583
• Other study ID #: 257/23
• Status: Active, not recruiting
• Start date: November 12, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: November 2023
• Source: Hospital Civil de Guadalajara
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5000
• Est. completion date: January 31, 2024
• Est. primary completion date: November 12, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 45 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Obstetric patients who enter the hospital intubated.

Related Conditions & MeSH terms

• Anesthesia
• Maternal-Fetal Relations
• Perinatal Morbidity

Locations

Country	Name	City	State
Mexico	Maria de Los Angeles Campechano Ascencio	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Civil de Guadalajara

Country where clinical trial is conducted

Mexico, 

References & Publications (52)

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* Note: There are 52 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency general anesthesia	Obtain the frequency of obstetric patients undergoing cesarean section surgery under general anesthesia	5 years
Primary	Maternal and fetal diagnosis	Specify the diagnoses for which general anesthesia is carried out	5 years
Primary	Classification physical status	Know the physical status of patients undergoing cesarean surgery	5 years
Primary	General anesthesia complications	Identify complications of the anesthetic technique	5 years
Primary	Maternal condition at the end of surgery	List the maternal discharge condition at the end of surgery (intubated/extubated)	5 years
Primary	Anesthetic induction	Describe the medications used for anesthetic induction	5 years
Primary	Prenatal classification by weight and gestational age	Document prenatal classification of the fetus by weight and gestational age assigned by ultrasound	5 years
Primary	Apgar Score	Record the newborn's Apgar score	5 years
Primary	Size at birth	Document birth size classification assigned by neonatology	5 years
Primary	Condition of the newborn	List the condition of the newborn after his or her initial evaluation (rooming-in/neonatal therapy)	5 years