Clinical trial NCT04634981: Does the Mode of Anesthesia Affect the Feto-maternal Outcome in Category-1 Caesarean Section
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia; Adverse Effect
Newborn Morbidity
Keywords: emergency cesarean section
general anesthesia
spinal
feto-maternal
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: full term pregnant women from 18-40 years old

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.

Eligibility 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.

Primary outcomes:
measure: APGAR score
timeFrame: 5 minutes after delivery
Secondary outcomes:
measure: decision-to-delivery interval (DDI)
timeFrame: from decision to operate till delivery of the baby
measure: Umbilical cord PH
timeFrame: immediately after delivery
measure: Occurrence of maternal complications postoperative
timeFrame: from recovery from anesthesia up to 24 hours postoperative
measure: Neonatal ICU admission
timeFrame: from delivery of the baby up to 24 hour postoperative
measure: Length of hospital stay
timeFrame: up to 1 month
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Samar Rafik Mohamed Amin
state: Qalubia
Study officials:
References: