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Clinical Trials/NCT04634981
NCT04634981
Completed
Not Applicable

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

Benha University1 site in 1 country74 target enrollmentAugust 12, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia; Adverse Effect
Sponsor
Benha University
Enrollment
74
Locations
1
Primary Endpoint
APGAR score
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 12, 2020
End Date
February 15, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Samar Rafik Mohamed Amin

lecturer of anesthesia and surgical ICU

Benha University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

  • Neonatal ICU admission(from delivery of the baby up to 24 hour postoperative)
  • Length of hospital stay(up to 1 month)
  • 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)

Study Sites (1)

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