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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Anesthesia; Adverse Effect, Newborn Morbidity

Intervention / Treatment
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* Procedure: anesthesia of emergency cesarean section


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group general anesthesia (G)<br>patients will positioned with pelvic wedge on operating table and preoxygenated. Then rapid sequence induction with precalculated doses of propofol (2 mg/kg) and rocuronium (0.9 mg/kg) will followed by endotracheal intubation. After delivery of the baby, fentanyl will be administered. Later, anesthesia will be maintained with isoflurane (1%). | Procedure: anesthesia of emergency cesarean section<br>* compare General versus spinal anesthesia<br>|
| Group Spinal anesthesia (S)<br>all parturients will co-loaded with 500 ml of colloid solution. In the left lateral position, the patients' back will be cleaned with povidone iodine. In the meantime, the spinal anesthetic drug and local anesthetic drug will be prepared. After wiping povidone iodine with alcohol, a rapid single shot of 2.5 ml of 0.5% hyperbaric bupivacaine will be administered intrathecally using 22 G spinal needle. Oxygen will be administered using simple face mask till the delivery of the baby. | Procedure: anesthesia of emergency cesarean section<br>* compare General versus spinal anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| APGAR score | Apgar score is a method for assessment of neonatal well-being after birth (0-3: severely depressed, 4-6: moderately depressed, 7-10: excellent condition) | 5 minutes after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decision-to-delivery interval (DDI) | the interval in minutes from the time of the decision by obstetrician to the time of delivery of the baby | from decision to operate till delivery of the baby | 
| Umbilical cord PH | Arterial blood gases from umbilical cord artery were used to assess newborn's acid-base status | immediately after delivery | 
| Occurrence of maternal complications postoperative | all mother were followed for any postoperative complications related to the anesthesia. | from recovery from anesthesia up to 24 hours postoperative | 
| Neonatal ICU admission | Admission to the NICU in percentage of the total participants. | from delivery of the baby up to 24 hour postoperative | 
| Length of hospital stay | Length of stay (LOS) is the duration of a single episode of hospitalization | up to 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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emergency cesarean section, general anesthesia, spinal, feto-maternal