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

Anesthesia; Adverse Effect Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04634981
• Other study ID #: REC-FOMBU 000048
• Status: Completed
• Start date: August 12, 2020
• Est. completion date: February 15, 2021

Study information

• Verified date: November 2020
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: February 15, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia; Adverse Effect
• Newborn Morbidity

Intervention

Procedure:
• anesthesia of emergency cesarean section
compare General versus spinal anesthesia

Locations

Country	Name	City	State
Egypt	Samar Rafik Mohamed Amin	Banha	Qalubia

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Umbilical cord PH	Arterial blood gases from umbilical cord artery were used to assess newborn's acid-base status	immediately after delivery
Secondary	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
Secondary	Neonatal ICU admission	Admission to the NICU in percentage of the total participants.	from delivery of the baby up to 24 hour postoperative
Secondary	Length of hospital stay	Length of stay (LOS) is the duration of a single episode of hospitalization	up to 1 month