Cesarean SectionNCT07513870
Comparing Inhalational Anesthesia and TIVA on Maternal and Neonatal Hemodynamics in Elective Cesarean Section
A study testing Propofol and Sevoflurane in people with Cesarean Section and Anesthesia, General, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This prospective, double-blind, randomized controlled trial compares the effects of total intravenous anesthesia (TIVA) versus sevoflurane-based inhalational anesthesia on maternal hemodynamics, depth of anesthesia, and early neonatal clinical outcomes in pregnant women undergoing elective cesarean section under… Read more about this study
- Who is it for?
- Ages 21 to 41 years, women only
- Conditions the study is for
- Cesarean Section, Anesthesia, General, Anesthesia, Intravenous
- What is being tested?
- Propofol and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2024to 5 Jan 2026
- Phase
- Interventional
- 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 21 to 41 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women scheduled for elective cesarean section under general anesthesia.
- Gestational age of 38 weeks or greater.
- American Society of Anesthesiologists (ASA) physical status II.
Who cannot join
- Emergency cesarean section (Category 1 and 2).
- Presence of fetal distress. * ASA physical status III or higher.
- Preference for regional anesthesia.
- Antenatally detected fetal anomalies.
- Multiple pregnancies.
- Estimated birth weight less than 2400 grams.
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- Known allergy to the study drugs or intraoperative adverse drug reactions.
- Severe eclampsia.
- Patients requiring conversion to general anesthesia due to inadequate spinal block.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing The Effects Of Inhalational Anesthesia And Total Intravenous Anesthesia On Maternal And Neonatal Hemodynamic Dynamics In Elective Cesarean Section: A Prospective, Double-Blind, Randomized Controlled Trial
This prospective, double-blind, randomized controlled trial compares the effects of total intravenous anesthesia (TIVA) versus sevoflurane-based inhalational anesthesia on maternal hemodynamics, depth of anesthesia, and early neonatal clinical outcomes in pregnant women undergoing elective cesarean section under general anesthesia
Read the detailed description
Elective cesarean sections under general anesthesia present a unique clinical setting where maternal ventilation and depth of anesthesia directly influence uteroplacental circulation and neonatal adaptation. This single-center study included 80 pregnant women (ASA physical status II, 38 weeks of gestation or more) randomly allocated into two groups: the TIVA group (n=39) receiving propofol and remifentanil, and the Sevoflurane group (n=41) receiving sevoflurane and fentanyl. The study evaluates intraoperative maternal hemodynamics, Bispectral Index (BIS) monitoring for depth of anesthesia, postoperative pain using the Numeric Rating Scale (NRS), and neonatal outcomes including Apgar scores, the Neurologic and Adaptive Capacity Score (NACS), and umbilical cord blood gas analysis.
- Being tested
- Propofol, Sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Administered intravenously for induction at a dose of 2 to 2.5 mg/kg. For maintenance in the TIVA group, a 2% propofol infusion was started at 14 mg/kg/hour at the 1st minute post-intubation, then decreased to 11 mg/kg/hour. The infusion rate was increased by increments of 2 mg/kg/hour if the Bispectral Index (BIS) exceeded 50 or if the heart rate increased by 10-20% from baseline. Following fascia closure, the rate was reduced to 6 mg/kg/hour and discontinued completely at skin closure.
SevofluraneDrug
Following induction and intubation, anesthesia maintenance was carried out with 2-3% sevoflurane in a 50% oxygen-air mixture using low-flow inhalation anesthesia (1 L/min fresh gas flow). The concentration of the inhalational anesthetic agent was gradually titrated to maintain the target Bispectral Index (BIS) value between 40 and 55 throughout the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Total Intravenous Anesthesia (TIVA) | Active comparator | Patients received propofol (2-2.5 mg/kg) and rocuronium for induction. Anesthesia was maintained with a propofol infusion (titrated according to hemodynamics and to maintain BIS between 40-55). Following delivery, remifentanil infusion was administered. Receives: Drug: Propofol |
| Sevoflurane Anesthesia | Active comparator | Patients received propofol (2-2.5 mg/kg) and rocuronium for induction. Anesthesia was maintained with 2-3% sevoflurane in an oxygen-air mixture, titrated to maintain BIS between 40-55. Following delivery, an intravenous bolus of fentanyl was administered. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depth of Anesthesia Assessed by Bispectral Index (BIS)
Anesthesia depth was monitored continuously using a four-channel frontal pEEG electrode to maintain a target BIS value between 40 and 55. The Bispectral Index scale ranges from a minimum of 0 to a maximum of 100. Lower scores indicate deeper sedation/anesthesia, while higher scores indicate a more awake state
Measured: During surgery (at 1, 2, 5, 10, 20, 30, 40 minutes and at the end of surgery)
Neonatal Neurologic and Adaptive Capacity Score (NACS)
The Neonatal Neurologic and Adaptive Capacity Score (NACS) is a neurobehavioral assessment scale for newborns. The scale ranges from a minimum score of 0 to a maximum score of 40. Higher scores indicate a better outcome (better neurological adaptation). Scores of 35 or above indicate normal/adequate neurological adaptation, while scores below 35 indicate inadequate adaptation
Measured: At 1 minute, 1 hour, and 24 hours post-delivery
Secondary outcomes (9)
Umbilical Cord Arterial pH
Analysis of umbilical cord blood evaluating pH, to assess the newborn's immediate postnatal transition and metabolic state.
Measured: within the first 5 minutes after delivery
Umbilical Cord Arterial pco2
Analysis of umbilical cord blood evaluating PCO2, to assess the newborn's immediate postnatal transition and metabolic state.
Measured: Within the first 5 minutes after delivery
Umbilical Cord Arterial po2
Analysis of umbilical cord blood evaluating PO2, to assess the newborn's immediate postnatal transition and metabolic state.
Measured: Within the first 5 minutes after delivery
Umbilical Cord total hemoglobin
Analysis of umbilical cord blood evaluating total hemoglobin, to assess the newborn's immediate postnatal transition and metabolic state.
Measured: Within the first 5 minutes after delivery
Umbilical Cord glucose levels
Analysis of umbilical cord blood evaluating glucose levels, to assess the newborn's immediate postnatal transition and metabolic state
Measured: Within the first 5 minutes after delivery
Maternal Systolic Blood Pressure (Unit: mmHg)
Continuous monitoring of systolic arterial blood pressures to assess maternal cardiovascular stability.
Measured: Intraoperative (Recorded from induction to the end of the operation)
Maternal diastolic Blood Pressure (Unit: mmHg)
Continuous monitoring of diastolic arterial blood pressures, to assess maternal cardiovascular stability.
Measured: Intraoperative (Recorded from induction to the end of the operation)
Maternal mean Blood Pressure (Unit: mmHg)
Continuous monitoring of mean arterial blood pressures, to assess maternal cardiovascular stability.
Measured: Intraoperative (Recorded from induction to the end of the operation)
Maternal Heart Rate
Continuous monitoring of heart rate to assess maternal cardiovascular stability.
Measured: Intraoperative (Recorded from induction to the end of the operation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start15 Mar 2024
- Primary completion1 Dec 2025
- Study completion5 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Medipol 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Omur, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513870
- Sponsor's protocol ID
- 302 14.03.2024
- Status last verified
- Apr 2026
- First submitted
- 19 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing The Effects Of Inhalational Anesthesia And Total Intravenous Anesthesia On Maternal And Neonatal Hemodynamic Dynamics In Elective Cesarean Section: A Prospective, Double-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07513870
- Acronym / sponsor ID
- 302 14.03.2024
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 7 Apr 2026 (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.
This prospective, double-blind, randomized controlled trial compares the effects of total intravenous anesthesia (TIVA) versus sevoflurane-based inhalational anesthesia on maternal hemodynamics, depth of anesthesia, and early neonatal clinical outcomes in pregnant women undergoing elective cesarean section under general anesthesia
Detailed description
Elective cesarean sections under general anesthesia present a unique clinical setting where maternal ventilation and depth of anesthesia directly influence uteroplacental circulation and neonatal adaptation. This single-center study included 80 pregnant women (ASA physical status II, 38 weeks of gestation or more) randomly allocated into two groups: the TIVA group (n=39) receiving propofol and remifentanil, and the Sevoflurane group (n=41) receiving sevoflurane and fentanyl. The study evaluates intraoperative maternal hemodynamics, Bispectral Index (BIS) monitoring for depth of anesthesia, postoperative pain using the Numeric Rating Scale (NRS), and neonatal outcomes including Apgar scores, the Neurologic and Adaptive Capacity Score (NACS), and umbilical cord blood gas analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Intravenous Anesthesia (TIVA) | Active comparator | Drug: PropofolPatients received propofol (2-2.5 mg/kg) and rocuronium for induction. Anesthesia was maintained with a propofol infusion (titrated according to hemodynamics and to maintain BIS between 40-55). Following delivery, remifentanil infusion was administered. |
| Sevoflurane Anesthesia | Active comparator | Drug: SevofluranePatients received propofol (2-2.5 mg/kg) and rocuronium for induction. Anesthesia was maintained with 2-3% sevoflurane in an oxygen-air mixture, titrated to maintain BIS between 40-55. Following delivery, an intravenous bolus of fentanyl was administered. |
Who may qualify
- Ages
- 21 to 41 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnant women scheduled for elective cesarean section under general anesthesia.
- Gestational age of 38 weeks or greater.
- American Society of Anesthesiologists (ASA) physical status II.
Key exclusion criteria (9 listed)
- Emergency cesarean section (Category 1 and 2).
- Presence of fetal distress. * ASA physical status III or higher.
- Preference for regional anesthesia.
- Antenatally detected fetal anomalies.
- Multiple pregnancies.
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 |
|---|---|---|
| PropofolAdministered intravenously for induction at a dose of 2 to 2.5 mg/kg. For maintenance in the TIVA group, a 2% propofol infusion was started at 14 mg/kg/hour at the 1st minute post-intubation, then decreased to 11 mg/kg/hour. The infusion rate was increased by increments of 2 mg/kg/hour if the Bispectral Index (BIS) exceeded 50 or if the heart rate increased by 10-20% from baseline. Following fascia closure, the rate was reduced to 6 mg/kg/hour and discontinued completely at skin closure. | Drug | Total Intravenous Anesthesia (TIVA) |
| SevofluraneFollowing induction and intubation, anesthesia maintenance was carried out with 2-3% sevoflurane in a 50% oxygen-air mixture using low-flow inhalation anesthesia (1 L/min fresh gas flow). The concentration of the inhalational anesthetic agent was gradually titrated to maintain the target Bispectral Index (BIS) value between 40 and 55 throughout the surgery. | Drug | Sevoflurane Anesthesia |
Primary outcome
Depth of Anesthesia Assessed by Bispectral Index (BIS)
Time frame: During surgery (at 1, 2, 5, 10, 20, 30, 40 minutes and at the end of surgery)
Anesthesia depth was monitored continuously using a four-channel frontal pEEG electrode to maintain a target BIS value between 40 and 55. The Bispectral Index scale ranges from a minimum of 0 to a maximum of 100. Lower scores indicate deeper sedation/anesthesia, while higher scores indicate a more awake state
Neonatal Neurologic and Adaptive Capacity Score (NACS)
Time frame: At 1 minute, 1 hour, and 24 hours post-delivery
The Neonatal Neurologic and Adaptive Capacity Score (NACS) is a neurobehavioral assessment scale for newborns. The scale ranges from a minimum score of 0 to a maximum score of 40. Higher scores indicate a better outcome (better neurological adaptation). Scores of 35 or above indicate normal/adequate neurological adaptation, while scores below 35 indicate inadequate adaptation
9 secondary outcomes
Umbilical Cord Arterial pH
Time frame: within the first 5 minutes after delivery
Umbilical Cord Arterial pco2
Time frame: Within the first 5 minutes after delivery
Umbilical Cord Arterial po2
Time frame: Within the first 5 minutes after delivery
Umbilical Cord total hemoglobin
Time frame: Within the first 5 minutes after delivery
Umbilical Cord glucose levels
Time frame: Within the first 5 minutes after delivery
Maternal Systolic Blood Pressure (Unit: mmHg)
Time frame: Intraoperative (Recorded from induction to the end of the operation)
Maternal diastolic Blood Pressure (Unit: mmHg)
Time frame: Intraoperative (Recorded from induction to the end of the operation)
Maternal mean Blood Pressure (Unit: mmHg)
Time frame: Intraoperative (Recorded from induction to the end of the operation)
Maternal Heart Rate
Time frame: Intraoperative (Recorded from induction to the end of the operation)
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 7 Apr 2026.
- Individual participant dataSharing planned: No
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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?
A study testing Propofol and Sevoflurane in people with Cesarean Section and Anesthesia, General, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. 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 7 Apr 2026. 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 Turkey (Türkiye). 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?
Depth of Anesthesia Assessed by Bispectral Index (BIS) (time frame: During surgery (at 1, 2, 5, 10, 20, 30, 40 minutes and at the end of surgery)). The study lists 2 primary outcomes in all. 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 7 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.