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Completed

NCT Number: NCT04634981

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

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.

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Key information

Conditions

Anesthesia; Adverse Effect Newborn Morbidity

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Samar Rafik Mohamed Amin

Banhā, Qalyubia Governorate, 13511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

anesthesia of emergency cesarean section

Procedure

compare General versus spinal anesthesia

Primary outcomes

  1. APGAR score

    Time frame: 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 outcomes

  1. decision-to-delivery interval (DDI)

    Time frame: 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

  2. Umbilical cord PH

    Time frame: immediately after delivery

    Arterial blood gases from umbilical cord artery were used to assess newborn's acid-base status

  3. Occurrence of maternal complications postoperative

    Time frame: from recovery from anesthesia up to 24 hours postoperative

    all mother were followed for any postoperative complications related to the anesthesia.

  4. Neonatal ICU admission

    Time frame: from delivery of the baby up to 24 hour postoperative

    Admission to the NICU in percentage of the total participants.

  5. Length of hospital stay

    Time frame: up to 1 month

    Length of stay (LOS) is the duration of a single episode of hospitalization

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 18, 2020
Registry last updated
Sep 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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