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Does the Mode of Anesthesia Affect the Feto-maternal Outcome in Category-1 Caesarean Section

Does the Mode of Anesthesia Affect the Feto-maternal Outcome in Category-1 Caesarean Section: A Prospective Non-randomized Study Comparing Spinal Versus General Anesthesia

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04634981
Enrollment
74
Registered
2020-11-18
Start date
2020-08-12
Completion date
2021-02-15
Last updated
2021-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia; Adverse Effect, Newborn Morbidity

Keywords

emergency cesarean section, general anesthesia, spinal, feto-maternal

Brief summary

Spinal anesthesia (SA) has become the standard technique in elective cesarean section (CS) as it results in less maternal and neonatal morbidity than general anesthesia (GA) (Grade-A recommendation, NICE). For women requiring emergency CS, rapid sequence general anesthesia (RSGA) is commonly used because this technique is faster to perform than SA. Though several randomized trials have compared the maternal and fetal outcome between these two anesthetic techniques, the studies with respect to category 1 CS (emergent conditions that hold immediate threat to life of the woman or fetus) are limited.

Detailed description

Full term pregnant females will be included in this study. They will be allocated into two groups: (Group G): will receive rapid sequence general anesthesia, and (Group S): will receive spinal anesthesia. After preoperative assessment and investigations by the attending anesthesiologist, the decision of the anesthetic approach will be decided by the attending anesthesiologist according to indications for CS. Before induction of anesthesia intravenous (IV) ranitidine 50 mg will be administered after establishing an IV access. On the operating table, vital signs will be monitored for all parturients throughout the surgery according to the standard departmental protocol. fetal well being will be assessed after delivery by using 1 minute and 5 min APGAR score and umbilical cord PH . in addition to maternal vital signs intra-operative then follow up any complications that may occur to the mother post-operative.

Interventions

PROCEDUREanesthesia of emergency cesarean section

compare General versus spinal anesthesia

Sponsors

Benha University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

following inclusion criteria: * American Society of Anesthesiologists physical status (ASA) \< III * Age 18-40 year * Gestational age\>37 weeks * Emergency cesarean delivery * Singleton pregnancy The

Exclusion criteria

are: * Twin pregnancy * Disagreement of the patient * Neurological impairment * Congenital fetal abnormality * body mass index \> 40 kg/m2; and * Sensitivity to any of the drugs used during the emergency CS.

Design outcomes

Primary

MeasureTime frameDescription
APGAR score5 minutes after deliveryApgar score is a method for assessment of neonatal well-being after birth (0-3: severely depressed, 4-6: moderately depressed, 7-10: excellent condition)

Secondary

MeasureTime frameDescription
decision-to-delivery interval (DDI)from decision to operate till delivery of the babythe interval in minutes from the time of the decision by obstetrician to the time of delivery of the baby
Umbilical cord PHimmediately after deliveryArterial blood gases from umbilical cord artery were used to assess newborn's acid-base status
Occurrence of maternal complications postoperativefrom recovery from anesthesia up to 24 hours postoperativeall mother were followed for any postoperative complications related to the anesthesia.
Neonatal ICU admissionfrom delivery of the baby up to 24 hour postoperativeAdmission to the NICU in percentage of the total participants.
Length of hospital stayup to 1 monthLength of stay (LOS) is the duration of a single episode of hospitalization

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026