AnalgesiaNCT06018805
The Effect of Combined Spinal Epidural Anaesthesia on QTc Interval Undergoing Cesarean Section
A study testing BMI≥30; Combined Spinal Epidural Anesthesia and BMI:18,5-24,9; Combined Spinal Epidural Anesthesia in people with Analgesia, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Cesarean section is the operation to deliver the fetus, placenta and membranes by making an abdominal incision in the uterus. Cesarean section is performed for reasons such as head-pelvis incompatibility, fetal malposition, fetal distress, and previous cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- BMI≥30; Combined Spinal Epidural Anesthesia and BMI:18,5-24,9; Combined Spinal Epidural Anesthesia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jul 2023to 31 Dec 2024
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants with BMI≥30 and BMI values between 18.5 and 24.9.
Who cannot join
- allergic to the drugs used in the study,
- who do not accept regional anesthesia,
- body mass index did not meet the inclusion criteria in the study,
- under 150 cm in height,
- who received treatment other than perinatal iron and vitamin drugs,
- smoking or drinking alcohol,
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- with a known fetal anomaly,
- with placental disorders such as placenta previa,
- with multiple pregnancy
- have renal or liver disease,
- diagnosed with hypertension or preeclampsia,
- uncooperative and previously treated or currently receiving treatment for a psychiatric disorder
- Mothers who do not want to participate in the study will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ataturk University
Erzurum, 25100
Mehmet Aksoy, +905058193526, drmaksoy@hotmail.com
About this study
Official title: The Effect of Combined Spinal Epidural Anaesthesia on QTc Interval in Obese and Non-obese Parturients Undergoing Cesarean Section: A Comparative Study
Cesarean section is the operation to deliver the fetus, placenta and membranes by making an abdominal incision in the uterus. Cesarean section is performed for reasons such as head-pelvis incompatibility, fetal malposition, fetal distress, and previous cesarean section.
The most important side effects of spinal anaesthesia are problems such as hypotension, bradycardia, low back pain, headache, nausea, vomiting, meningitis, meningismus, and urinary retention.
Read more
Combined spinal-epidural (BSI) anaesthesia is the application of spinal and epidural anaesthesia together. High-dose local anaesthetics can cause significant hypotension when the epidural block is administered alone. The administration of spinal anaesthesia alone causes changes in arterial resistance, stroke volume, heart rate, cardiac output and arterial blood pressure. Sympathetic blockade leads to arterial vasodilation, and arterial resistance may decrease by 5-20% during spinal anaesthesia.
Due to the increased risk of maternal complications in obese pregnant, fetal morbidity and mortality have increased. In addition, supine hypotension syndrome is a common problem in obese pregnant women. The aim of this study is to compare the change in QTc interval in obese and non-obese term pregnancies planned for elective cesarean section with combined spinal epidural anaesthesia. Thus, it is aimed to develop new protocols that will minimize cardiac pathologies during and after surgery in obese pregnant women.
- Conditions
- Analgesia
- Being tested
- BMI≥30; Combined Spinal Epidural Anesthesia, BMI:18,5-24,9; Combined Spinal Epidural Anesthesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMI≥30; Combined Spinal Epidural AnesthesiaOther
Combined epidural spinal anesthesia will be performed with the loss of resistance method at constant volume and concentration ( in both patient groups. For QT interval measurements, ECG recordings will be taken before spinal anesthesia, 5 and 30 minutes after the block, and 60 and 120 minutes postoperatively.
BMI:18,5-24,9; Combined Spinal Epidural AnesthesiaOther
Combined epidural spinal anesthesia will be performed with the loss of resistance method at constant volume and concentration in both patient groups. For QT interval measurements, ECG recordings will be taken before spinal anesthesia, 5 and 30 minutes after the block, and 60 and 120 minutes postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Body Mass Index≥30 kg/m2 | Active comparator | Pregnant women with a Body Mass Index≥30 kg/m2 will be included. Receives: Other: BMI≥30; Combined Spinal Epidural Anesthesia |
| Body Mass Index: 18,5 - 24,9 kg/m2 | Active comparator | Pregnant women with a Body Mass Index between 18.5 and 24.9 kg/m2 will be included. Receives: Other: BMI:18,5-24,9; Combined Spinal Epidural Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
QTc interval
The primary aim of this study was to reveal the difference in QTc interval between groups.
Measured: first 2 hour starting from the time of CSE performed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start24 Jul 2023
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet AKSOY, Ataturk University
- Investigators
- Mehmet Aksoy, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018805
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/408
- Status last verified
- Feb 2024
- First submitted
- 24 Jul 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kumar T, Jha K, Sharan A, Sakshi P, Kumar S, Kumari A. Study of the effect of obesity on QT-interval among adults. J Family Med Prim Care. 2019 May;8(5):1626-1629. doi: 10.4103/jfmpc.jfmpc_168_19.
PubMed 31198727Song JH, Yang C, Lee W, Kim H, Kim Y, Kim H. QTc interval prolongation due to spinal anesthesia in patients with and without diabetes: an observational study. BMC Anesthesiol. 2022 May 13;22(1):143. doi: 10.1186/s12871-022-01614-8.
PubMed 35562669
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combined Spinal Epidural Anaesthesia on QTc Interval in Obese and Non-obese Parturients Undergoing Cesarean Section: A Comparative Study
- ClinicalTrials.gov ID
- NCT06018805
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/408
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 31 Aug 2023 (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.
Cesarean section is the operation to deliver the fetus, placenta and membranes by making an abdominal incision in the uterus. Cesarean section is performed for reasons such as head-pelvis incompatibility, fetal malposition, fetal distress, and previous cesarean section.
The most important side effects of spinal anaesthesia are problems such as hypotension, bradycardia, low back pain, headache, nausea, vomiting, meningitis, meningismus, and urinary retention.
Combined spinal-epidural (BSI) anaesthesia is the application of spinal and epidural anaesthesia together. High-dose local anaesthetics can cause significant hypotension when the epidural block is administered alone. The administration of spinal anaesthesia alone causes changes in arterial resistance, stroke volume, heart rate, cardiac output and arterial blood pressure. Sympathetic blockade leads to arterial vasodilation, and arterial resistance may decrease by 5-20% during spinal anaesthesia.
Due to the increased risk of maternal complications in obese pregnant, fetal morbidity and mortality have increased. In addition, supine hypotension syndrome is a common problem in obese pregnant women. The aim of this study is to compare the change in QTc interval in obese and non-obese term pregnancies planned for elective cesarean section with combined spinal epidural anaesthesia. Thus, it is aimed to develop new protocols that will minimize cardiac pathologies during and after surgery in obese pregnant women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Body Mass Index≥30 kg/m2 | Active comparator | Other: BMI≥30; Combined Spinal Epidural AnesthesiaPregnant women with a Body Mass Index≥30 kg/m2 will be included. |
| Body Mass Index: 18,5 - 24,9 kg/m2 | Active comparator | Other: BMI:18,5-24,9; Combined Spinal Epidural AnesthesiaPregnant women with a Body Mass Index between 18.5 and 24.9 kg/m2 will be included. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants with BMI≥30 and BMI values between 18.5 and 24.9.
Key exclusion criteria (13 listed)
- allergic to the drugs used in the study,
- who do not accept regional anesthesia,
- body mass index did not meet the inclusion criteria in the study,
- under 150 cm in height,
- who received treatment other than perinatal iron and vitamin drugs,
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 |
|---|---|---|
| BMI≥30; Combined Spinal Epidural AnesthesiaCombined epidural spinal anesthesia will be performed with the loss of resistance method at constant volume and concentration ( in both patient groups. For QT interval measurements, ECG recordings will be taken before spinal anesthesia, 5 and 30 minutes after the block, and 60 and 120 minutes postoperatively. | Other | Body Mass Index≥30 kg/m2 |
| BMI:18,5-24,9; Combined Spinal Epidural AnesthesiaCombined epidural spinal anesthesia will be performed with the loss of resistance method at constant volume and concentration in both patient groups. For QT interval measurements, ECG recordings will be taken before spinal anesthesia, 5 and 30 minutes after the block, and 60 and 120 minutes postoperatively. | Other | Body Mass Index: 18,5 - 24,9 kg/m2 |
Primary outcome
QTc interval
Time frame: first 2 hour starting from the time of CSE performed.
The primary aim of this study was to reveal the difference in QTc interval between groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Background: PubMed 31198727Kumar T, Jha K, Sharan A, Sakshi P, Kumar S, Kumari A. Study of the effect of obesity on QT-interval among adults. J Family Med Prim Care. 2019 May;8(5):1626-1629. doi: 10.4103/jfmpc.jfmpc_168_19.
- Background: PubMed 35562669Song JH, Yang C, Lee W, Kim H, Kim Y, Kim H. QTc interval prolongation due to spinal anesthesia in patients with and without diabetes: an observational study. BMC Anesthesiol. 2022 May 13;22(1):143. doi: 10.1186/s12871-022-01614-8.
- 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.
Mehmet Aksoy study director
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BMI≥30; Combined Spinal Epidural Anesthesia and BMI:18,5-24,9; Combined Spinal Epidural Anesthesia in people with Analgesia, run by Ataturk 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 1 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 6 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mehmet Aksoy (+905058193526, drmaksoy@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QTc interval (time frame: first 2 hour starting from the time of CSE performed.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06018805, which also lists 2 linked publications.
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 6 Feb 2024.