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

NCT04634981 | Completed DMC

• 1 other identifier: REC-FOMBU 000048
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Adverse Effect; Newborn Morbidity

Keywords

emergency cesarean section; general anesthesia; spinal; feto-maternal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• decision-to-delivery interval (DDI)

  from decision to operate till delivery of the baby

• Umbilical cord PH

  immediately after delivery

• Occurrence of maternal complications postoperative

  from recovery from anesthesia up to 24 hours postoperative

• Neonatal ICU admission

  from delivery of the baby up to 24 hour postoperative

• Length of hospital stay

  up to 1 month

Study Arms (2)

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

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

Interventions

anesthesia of emergency cesarean section PROCEDURE

compare General versus spinal anesthesia

Group Spinal anesthesia (S); Group general anesthesia (G)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: full term pregnant females
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

full term pregnant women from 18-40 years old

You may qualify if:

• American Society of Anesthesiologists physical status (ASA) \< III
• Age 18-40 year
• Gestational age\>37 weeks
• Emergency cesarean delivery
• Singleton pregnancy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Samar Rafik Mohamed Amin

Banhā, Qalyubia Governorate, 13511, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and surgical ICU

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: November 18, 2020
• Study Start: August 12, 2020
• Primary Completion: January 30, 2021
• Study Completion: February 15, 2021
• Last Updated: September 17, 2021

Record last verified: 2020-11

Locations

EG (1)