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

NCT ID: NCT04634981

Last Updated: 2021-09-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 74 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-08-12
• Study Completion Date: 2021-02-15

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.

Conditions

Anesthesia; Adverse Effect; Newborn Morbidity

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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%).

anesthesia of emergency cesarean section

Intervention Type: PROCEDURE

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.

anesthesia of emergency cesarean section

Intervention Type: PROCEDURE

compare General versus spinal anesthesia

Interventions

anesthesia of emergency cesarean section

compare General versus spinal anesthesia

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Samar Rafik Mohamed Amin

lecturer of anesthesia and surgical ICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Samar Rafik Mohamed Amin

Banhā, Qalyubia Governorate, Egypt

Countries

Egypt

Other Identifiers

REC-FOMBU 000048

Identifier Type: -

Identifier Source: org_study_id