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

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.

Study Overview

• Status: Completed
• Conditions: Newborn Morbidity; Anesthesia; Adverse Effect
• Intervention / Treatment: Procedure: anesthesia of emergency cesarean section

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 Type: Observational
• Enrollment (Actual): 74

Contacts and Locations

Study Locations

• Egypt
  • Qalubia
    • Banhā, Qalubia, Egypt, 13511
      • Samar Rafik Mohamed Amin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

full term pregnant women from 18-40 years old

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group general anesthesia (G); 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; compare General versus spinal anesthesia
Group Spinal anesthesia (S); 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; compare General versus spinal anesthesia

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Benha University

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2020
• Primary Completion (Actual): January 30, 2021
• Study Completion (Actual): February 15, 2021

Study Registration Dates

• First Submitted: October 23, 2020
• First Submitted That Met QC Criteria: November 17, 2020
• First Posted (Actual): November 18, 2020

Study Record Updates

• Last Update Posted (Actual): September 17, 2021
• Last Update Submitted That Met QC Criteria: September 12, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: general anesthesia; spinal; emergency cesarean section; feto-maternal
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: REC-FOMBU 000048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No