Anesthesia; Adverse EffectNCT04634981
Does the Mode of Anesthesia Affect the Feto-maternal Outcome in Category-1 Caesarean Section
An observational study of Anesthesia; Adverse Effect and Newborn Morbidity, run by Benha University at 1 site in Egypt.
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). Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Anesthesia; Adverse Effect, Newborn Morbidity
- What is being tested?
- anesthesia of emergency cesarean section
- Type of treatment
- Surgery or procedure
- How many people
- 74 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Aug 2020to 15 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: full term pregnant women from 18-40 years old
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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- anesthesia of emergency cesarean section
- Keywords
- emergency cesarean section, general anesthesia, spinal, feto-maternal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anesthesia of emergency cesarean sectionProcedure or surgery
compare General versus spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 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%). Receives: 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. Receives: Procedure: anesthesia of emergency cesarean section |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 5 minutes after delivery
Secondary outcomes (5)
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
Measured: from decision to operate till delivery of the baby
Umbilical cord PH
Arterial blood gases from umbilical cord artery were used to assess newborn's acid-base status
Measured: immediately after delivery
Occurrence of maternal complications postoperative
all mother were followed for any postoperative complications related to the anesthesia.
Measured: from recovery from anesthesia up to 24 hours postoperative
Neonatal ICU admission
Admission to the NICU in percentage of the total participants.
Measured: from delivery of the baby up to 24 hour postoperative
Length of hospital stay
Length of stay (LOS) is the duration of a single episode of hospitalization
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study start12 Aug 2020
- Primary completion30 Jan 2021
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia; Adverse EffectStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Rafik Mohamed Amin, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04634981
- Sponsor's protocol ID
- REC-FOMBU 000048
- Status last verified
- Nov 2020
- First submitted
- 23 Oct 2020
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04634981
- Acronym / sponsor ID
- REC-FOMBU 000048
- Conditions
- Anesthesia; Adverse Effect, Newborn Morbidity
- Keywords
- emergency cesarean section, general anesthesia, spinal, feto-maternal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group general anesthesia (G) | – | Procedure: anesthesia of emergency cesarean sectionpatients 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%). |
| Group Spinal anesthesia (S) | – | Procedure: anesthesia of emergency cesarean sectionall 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- full term pregnant women from 18-40 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anesthesia of emergency cesarean sectioncompare General versus spinal anesthesia | Procedure or surgery | Group Spinal anesthesia (S), Group general anesthesia (G) |
Primary outcome
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)
5 secondary outcomes
decision-to-delivery interval (DDI)
Time frame: from decision to operate till delivery of the baby
Umbilical cord PH
Time frame: immediately after delivery
Occurrence of maternal complications postoperative
Time frame: from recovery from anesthesia up to 24 hours postoperative
Neonatal ICU admission
Time frame: from delivery of the baby up to 24 hour postoperative
Length of hospital stay
Time frame: up to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia; Adverse Effect and Newborn Morbidity, run by Benha University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
APGAR score (time frame: 5 minutes after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2021.