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

Completed

• Conditions: Anesthesia; Adverse Effect; Newborn Morbidity
• Interventions: Procedure: anesthesia of emergency cesarean section

• Registration Number: NCT04634981
• Lead Sponsor: Benha University

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.

Study Timeline

• Study Start: 2020-08-12
• Study First Submitted: 2020-10-23
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-17
• Study First Posted: 2020-11-18
• Primary Completion: 2021-01-30
• Study Completion: 2021-02-15
• Last Update Submitted: 2021-09-12
• Last Update Posted: 2021-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 74

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group Spinal anesthesia (S)	anesthesia of emergency cesarean section	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.
Group general anesthesia (G)	anesthesia of emergency cesarean section	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%).

Primary Outcome Measures

Name	Time	Method
APGAR score	5 minutes after delivery	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Samar Rafik Mohamed Amin; 🇪🇬 Banhā, Qalubia, Egypt