PregnancyPhase 4NCT05892913
The Effect of Low-dose Atropine on Sympathetic Blockade in Spinal Cesarean Section Patients
A Phase 4 study testing Slow dose preemptive Atropine and Ephedrine in people with Pregnancy and Cesarean Section, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
The most common side effect in cesarean section surgeries performed under spinal anesthesia is hypotension, which is seen in over 80% and can cause significant morbidity for the mother and fetus. This side effect results from the sympathetic blocking effect, which also causes bradycardia. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pregnancy, Cesarean Section, Anesthesia, Spinal
- What is being tested?
- Slow dose preemptive Atropine and Ephedrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jul 2023to 10 Oct 2023
- Phase
- Phase 4
- 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
Who may be able to join
- ASA Ι-ΙΙ Ages 18-40 Weight 55-105 kg Height 150-175 cm
Who cannot join
- Who does not require drug administration with fluid therapy Whose hemodynamic changes are within an acceptable range Diabetes COPD Hypertension BMI>34 Preeclampsia/eclampsia Multiple pregnancies Pathology in the fetus Hematological problems such as Rh incompatibility Hypersensitivity to local anesthetics Contraindications to regional anesthesia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant Izzet Baysal university Medical School, Anesthesiology and Reanimation D.
Bolu, 14230
About this study
Official title: Treatment of Sympathetic Blockade During Spinal Anesthesia in Cesarian Section Patients With Low-dose, Slow-administered Preemptive Atropine
The most common side effect in cesarean section surgeries performed under spinal anesthesia is hypotension, which is seen in over 80% and can cause significant morbidity for the mother and fetus. This side effect results from the sympathetic blocking effect, which also causes bradycardia.
A combined approach is supported in the prevention and treatment of hypotension, which recommends adequate fluid support, low-dose spinal anesthesia, and appropriate vasopressor (such as ephedrine, and phenylephrine) and, if bradycardia develops, the use of atropine as a parasympatholytic agent.
In this study, the investigators planned to investigate the possible benefits of preemptive administration of atropine, the dose of which is calculated in proportion to the patient's weight, as soon as a 10% decrease in heart rate is detected, in order to balance the sympathetic blockade due to spinal anesthesia in cesarean section operations.
Read the detailed description
Our study was approved by the Ethics Committee of Bolu Abant Izzet Baysal University, ASA Ι-ΙΙ, ages 18-40, weight 55-105 kg, height 150-175 cm, with an indication for elective cesarean section, and informed consent will be obtained for the study. Sixty pregnant patients at term scheduled for cesarean delivery under spinal anesthesia will be included.
Those who do not require drug administration with fluid therapy, whose hemodynamic changes are within acceptable range, have systemic disease (Diabetes, COPD, Hypertension), have BMI>34, have a diagnosis of preeclampsia/eclampsia or multiple pregnancy, have pathology in the fetus, have hematological problems such as Rh incompatibility, patients with hypersensitivity to local anesthetics and who are in a position to be a contraindication to regional anesthesia applications will be excluded from the study.
Dexamethasone 4 mg IV for antiemetic purposes was planned for all patients as premedication before the intervention. It was planned to record systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), heart rate (HR), oxygen saturation (SpO2) and respiratory rates by noninvasive method by monitoring the patients with the Mindrey device. In all cases, 2 vascular accesses will be opened with an 18 G (Gauge) intravenous cannula. Intravenous pre-loading was planned for all cases, with 300 cc 0.9% NaCl removed in 15 minutes preoperatively.
Patients will be divided into 2 groups by online randomization method.(Studyrandomizer.com) Fixed dose local anesthetic will be preferred in both groups. After all cases are placed on the operating table and given an anatomical position suitable for spinal anesthesia in a sitting position, skin cleaning will be performed under sterile conditions in the area where the intervention will be performed. Appropriate intervertebral space (L3-L4) will be determined and when the free flow of CSF will be seen after entering the subarachnoid space with a sterile 25-27 G pencil point spinal needle (Egemen/ISTANBUL/TURKEY), 15 mg (2.5 mL) pure (isobaric 0.5% bupivacaine( Marcaine 0.5%/Astra Zeneca/England) ) will be applied. After the application, the patient will placed in the supine position and it will be planned to administer 3 L/min O2 by nasal cannula. After spinal anesthesia, it will planned to start 5 ml/kg/hour 0.9% NaCl solution (Neofleks/Ankara/Turkey) as a maintenance fluid for the patients in both groups during the operation.
In both groups, SBP, DBP, MBP, HR and SpO2 measurements will be recorded at 1, 4, 7, 9, 12, 15, 30, 45, 60, 120 and 240 minutes after the patient is placed left lateral tilt position on the table. After the spinal injection, sensory and motor block levels will be recorded every 3 minutes in the first 15 minutes, and then at the 20th, 25th, 30th, 45th and 60th minutes. It has planned to evaluate the level of sensory block as a dermatome level with the hot-cold test, and motor block by using the Bromage Scale.
The preoperative SBP, DBP, MBP, HR, SpO2 will be recorded before hydration and before spinal anesthesia of the patients will be taken as the baseline value.
For sympathetic blockade (SBP<80) developed in patients in the ephedrine group, a bolus dose of 5 mg/mL ephedrine will be used and repeated if necessary. In case of development of bradycardia (<65/min) in this group, Atropine 0.5 mg/mL will be planned to be administered and repeated if necessary.
In the atropine group, it was planned to administer 0.5 mg/4mL diluted atropine in 20 seconds(10mcg/kg), as a slow bolus as bradycardia would expected (10% reduction in peak heart rate after spinal anesthesia). Also in Atropine group if SBP<80 despite slow dose atropine administration it will be planed to give efedrine. And for bradicardia (HR<65/min) it will be planed to give Atropine 0.5 mg/mL.
The differences between total ephedrine\&Atropine consumption, HR,SBP and MBP values in both groups were planned to be the primary outcomes of the study. In addition, findings such as DBP value, nausea and dizziness will also be recorded as secondary outcomes.
- Conditions
- Pregnancy, Cesarean Section, Anesthesia, Spinal
- Being tested
- Slow dose preemptive Atropine, Ephedrine
- Keywords
- Pregnancy, Cesarean Section, Anesthesia, Spinal, Atropine, Sympatholytic Effect, Spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow dose preemptive AtropineDrug
Also called Atropine
it will planned to administer 0.4 mg/4mL diluted atropine in 20 seconds(10mcg/kg), as a slow bolus as bradycardia would expected (10% reduction in peak heart rate after spinal anesthesia)
EphedrineDrug
For sympathetic blockade (SBP<90) developed in patients in the ephedrine group, a bolus dose of 5 mg/mL ephedrine was used and repeated if necessary.
| Study group | Role | What they receive |
|---|---|---|
| Efedrine Group | Active comparator | For sympathetic blockade (SBP<90) if developed in patients in the ephedrine group, a bolus dose of 5 mg/mL ephedrine would be used and repeated if necessary. In case of development of bradycardia (<65/min) in this group, Atropine 0.5 mg/mL would be planned to be administered and repeated if necessary. Receives: Drug: Ephedrine |
| Preemptive Atropine Group | Experimental | In the atropine group, it will planned to administer 0.4 mg/4mL diluted atropine in 20 seconds(10mcg/kg), as a slow bolus as bradycardia would expected (10% reduction in peak heart rate after spinal anesthesia). In this group if SBP<90 despite slow dose atropine administration; it will be planed to give efedrine as bolus of 5 mg/mL. And for bradicardia (HR<65/min) it will be planed to give Atropine 0.5 mg/mL. Receives: Drug: Slow dose preemptive Atropine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Heart rate
Measured: 1. minunte after spinal block
Heart rate
Heart rate
Measured: 4. minute after spinal block
Heart rate
Heart rate
Measured: 7. minute after spinal block
Heart rate
Heart rate
Measured: 9. minute after spinal block
Heart rate
Heart rate
Measured: 12. minute after spinal block
Heart rate
Heart rate
Measured: 15. minute after spinal block
Systolic Blood pressure
Systolic Blood pressure
Measured: 1. minute after spinal block
Systolic Blood pressure
Systolic Blood pressure
Measured: 4. minute after spinal block
Systolic Blood pressure
Systolic Blood pressure
Measured: 7. minute after spinal block
Systolic Blood pressure
Systolic Blood pressure
Measured: 9. minute after spinal block
Systolic Blood pressure
Systolic Blood pressure
Measured: 12. minute after spinal block
Systolic Blood pressure
Systolic Blood pressure
Measured: 15. minute after spinal block
Mean Blood Pressure
Mean Blood Pressure
Measured: 1. minute after spinal block
Mean Blood Pressure
Mean Blood Pressure
Measured: 4. minute after spinal block
Mean Blood Pressure
Mean Blood Pressure
Measured: 7. minute after spinal block
Mean Blood Pressure
Mean Blood Pressure
Measured: 9. minute after spinal block
Mean Blood Pressure
Mean Blood Pressure
Measured: 12. minute after spinal block
Mean Blood Pressure
Mean Blood Pressure
Measured: 15. minute after spinal block
Efedrine Consumption
Efedrine Consumption in the first 15 minutes after the spinal block
Measured: 1. minute after spinal block
Efedrine Consumption
Efedrine Consumption in the first 15 minutes after the spinal block
Measured: 4. minute after spinal block
Efedrine Consumption
Efedrine Consumption in the first 15 minutes after the spinal block
Measured: 7. minute after spinal block
Efedrine Consumption
Efedrine Consumption in the first 15 minutes after the spinal block
Measured: 9. minute after spinal block
Efedrine Consumption
Efedrine Consumption in the first 15 minutes after the spinal block
Measured: 12. minute after spinal block
Efedrine Consumption
Efedrine Consumption in the first 15 minutes after the spinal block
Measured: 15. minute after spinal block
Atropine Consumption
Atropine Consumption in the first 15 minutes after the spinal block
Measured: 1. minute after spinal block
Atropine Consumption
Atropine Consumption in the first 15 minutes after the spinal block
Measured: 4. minute after spinal block
Atropine Consumption
Atropine Consumption in the first 15 minutes after the spinal block
Measured: 7. minute after spinal block
Atropine Consumption
Atropine Consumption in the first 15 minutes after the spinal block
Measured: 9. minute after spinal block
Atropine Consumption
Atropine Consumption in the first 15 minutes after the spinal block
Measured: 12. minute after spinal block
Atropine Consumption
Atropine Consumption in the first 15 minutes after the spinal block
Measured: 15. minute after spinal block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start19 Jul 2023
- Primary completion10 Oct 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akcan AKKAYA Prof. MD., Abant Izzet Baysal University
- Investigators
- Akcan Akkaya, MD., Principal investigator, Bolu Abant Izzet Baysal university Medical School, Anesthesiology and Reanimation D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892913
- Sponsor's protocol ID
- BAIBU-Anesthesia-AA-03
- Status last verified
- Oct 2023
- First submitted
- 27 May 2023
- Last updated
- 11 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Sympathetic Blockade During Spinal Anesthesia in Cesarian Section Patients With Low-dose, Slow-administered Preemptive Atropine
- ClinicalTrials.gov ID
- NCT05892913
- Acronym / sponsor ID
- BAIBU-Anesthesia-AA-03
- Conditions
- Pregnancy, Cesarean Section, Anesthesia, Spinal
- Keywords
- Pregnancy, Cesarean Section, Anesthesia, Spinal, Atropine, Sympatholytic Effect, Spinal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 19 Jul 2023 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 7 Jun 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.
The most common side effect in cesarean section surgeries performed under spinal anesthesia is hypotension, which is seen in over 80% and can cause significant morbidity for the mother and fetus. This side effect results from the sympathetic blocking effect, which also causes bradycardia.
A combined approach is supported in the prevention and treatment of hypotension, which recommends adequate fluid support, low-dose spinal anesthesia, and appropriate vasopressor (such as ephedrine, and phenylephrine) and, if bradycardia develops, the use of atropine as a parasympatholytic agent.
In this study, the investigators planned to investigate the possible benefits of preemptive administration of atropine, the dose of which is calculated in proportion to the patient's weight, as soon as a 10% decrease in heart rate is detected, in order to balance the sympathetic blockade due to spinal anesthesia in cesarean section operations.
Detailed description
Our study was approved by the Ethics Committee of Bolu Abant Izzet Baysal University, ASA Ι-ΙΙ, ages 18-40, weight 55-105 kg, height 150-175 cm, with an indication for elective cesarean section, and informed consent will be obtained for the study. Sixty pregnant patients at term scheduled for cesarean delivery under spinal anesthesia will be included.
Those who do not require drug administration with fluid therapy, whose hemodynamic changes are within acceptable range, have systemic disease (Diabetes, COPD, Hypertension), have BMI>34, have a diagnosis of preeclampsia/eclampsia or multiple pregnancy, have pathology in the fetus, have hematological problems such as Rh incompatibility, patients with hypersensitivity to local anesthetics and who are in a position to be a contraindication to regional anesthesia applications will be excluded from the study.
Dexamethasone 4 mg IV for antiemetic purposes was planned for all patients as premedication before the intervention. It was planned to record systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), heart rate (HR), oxygen saturation (SpO2) and respiratory rates by noninvasive method by monitoring the patients with the Mindrey device. In all cases, 2 vascular accesses will be opened with an 18 G (Gauge) intravenous cannula. Intravenous pre-loading was planned for all cases, with 300 cc 0.9% NaCl removed in 15 minutes preoperatively.
Patients will be divided into 2 groups by online randomization method.(Studyrandomizer.com) Fixed dose local anesthetic will be preferred in both groups. After all cases are placed on the operating table and given an anatomical position suitable for spinal anesthesia in a sitting position, skin cleaning will be performed under sterile conditions in the area where the intervention will be performed. Appropriate intervertebral space (L3-L4) will be determined and when the free flow of CSF will be seen after entering the subarachnoid space with a sterile 25-27 G pencil point spinal needle (Egemen/ISTANBUL/TURKEY), 15 mg (2.5 mL) pure (isobaric 0.5% bupivacaine( Marcaine 0.5%/Astra Zeneca/England) ) will be applied. After the application, the patient will placed in the supine position and it will be planned to administer 3 L/min O2 by nasal cannula. After spinal anesthesia, it will planned to start 5 ml/kg/hour 0.9% NaCl solution (Neofleks/Ankara/Turkey) as a maintenance fluid for the patients in both groups during the operation.
In both groups, SBP, DBP, MBP, HR and SpO2 measurements will be recorded at 1, 4, 7, 9, 12, 15, 30, 45, 60, 120 and 240 minutes after the patient is placed left lateral tilt position on the table. After the spinal injection, sensory and motor block levels will be recorded every 3 minutes in the first 15 minutes, and then at the 20th, 25th, 30th, 45th and 60th minutes. It has planned to evaluate the level of sensory block as a dermatome level with the hot-cold test, and motor block by using the Bromage Scale.
The preoperative SBP, DBP, MBP, HR, SpO2 will be recorded before hydration and before spinal anesthesia of the patients will be taken as the baseline value.
For sympathetic blockade (SBP<80) developed in patients in the ephedrine group, a bolus dose of 5 mg/mL ephedrine will be used and repeated if necessary. In case of development of bradycardia (<65/min) in this group, Atropine 0.5 mg/mL will be planned to be administered and repeated if necessary.
In the atropine group, it was planned to administer 0.5 mg/4mL diluted atropine in 20 seconds(10mcg/kg), as a slow bolus as bradycardia would expected (10% reduction in peak heart rate after spinal anesthesia). Also in Atropine group if SBP<80 despite slow dose atropine administration it will be planed to give efedrine. And for bradicardia (HR<65/min) it will be planed to give Atropine 0.5 mg/mL.
The differences between total ephedrine\&Atropine consumption, HR,SBP and MBP values in both groups were planned to be the primary outcomes of the study. In addition, findings such as DBP value, nausea and dizziness will also be recorded as secondary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Efedrine Group | Active comparator | Drug: EphedrineFor sympathetic blockade (SBP<90) if developed in patients in the ephedrine group, a bolus dose of 5 mg/mL ephedrine would be used and repeated if necessary. In case of development of bradycardia (<65/min) in this group, Atropine 0.5 mg/mL would be planned to be administered and repeated if necessary. |
| Preemptive Atropine Group | Experimental | Drug: Slow dose preemptive AtropineIn the atropine group, it will planned to administer 0.4 mg/4mL diluted atropine in 20 seconds(10mcg/kg), as a slow bolus as bradycardia would expected (10% reduction in peak heart rate after spinal anesthesia). In this group if SBP<90 despite slow dose atropine administration; it will be planed to give efedrine as bolus of 5 mg/mL. And for bradicardia (HR<65/min) it will be planed to give Atropine 0.5 mg/mL. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA Ι-ΙΙ Ages 18-40 Weight 55-105 kg Height 150-175 cm
Key exclusion criteria (1 listed)
- Who does not require drug administration with fluid therapy Whose hemodynamic changes are within an acceptable range Diabetes COPD Hypertension BMI>34 Preeclampsia/eclampsia Multiple pregnancies Pathology in the fetus Hematological problems such as Rh incompatibility Hypersensitivity to local anesthetics Contraindications to regional anesthesia
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 |
|---|---|---|
| Slow dose preemptive AtropineAlso: Atropineit will planned to administer 0.4 mg/4mL diluted atropine in 20 seconds(10mcg/kg), as a slow bolus as bradycardia would expected (10% reduction in peak heart rate after spinal anesthesia) | Drug | Preemptive Atropine Group |
| EphedrineFor sympathetic blockade (SBP<90) developed in patients in the ephedrine group, a bolus dose of 5 mg/mL ephedrine was used and repeated if necessary. | Drug | Efedrine Group |
Primary outcome
Heart rate
Time frame: 1. minunte after spinal block
Heart rate
Heart rate
Time frame: 4. minute after spinal block
Heart rate
Heart rate
Time frame: 7. minute after spinal block
Heart rate
Heart rate
Time frame: 9. minute after spinal block
Heart rate
Heart rate
Time frame: 12. minute after spinal block
Heart rate
Heart rate
Time frame: 15. minute after spinal block
Heart rate
Systolic Blood pressure
Time frame: 1. minute after spinal block
Systolic Blood pressure
Systolic Blood pressure
Time frame: 4. minute after spinal block
Systolic Blood pressure
Systolic Blood pressure
Time frame: 7. minute after spinal block
Systolic Blood pressure
Systolic Blood pressure
Time frame: 9. minute after spinal block
Systolic Blood pressure
Systolic Blood pressure
Time frame: 12. minute after spinal block
Systolic Blood pressure
Systolic Blood pressure
Time frame: 15. minute after spinal block
Systolic Blood pressure
Mean Blood Pressure
Time frame: 1. minute after spinal block
Mean Blood Pressure
Mean Blood Pressure
Time frame: 4. minute after spinal block
Mean Blood Pressure
Mean Blood Pressure
Time frame: 7. minute after spinal block
Mean Blood Pressure
Mean Blood Pressure
Time frame: 9. minute after spinal block
Mean Blood Pressure
Mean Blood Pressure
Time frame: 12. minute after spinal block
Mean Blood Pressure
Mean Blood Pressure
Time frame: 15. minute after spinal block
Mean Blood Pressure
Efedrine Consumption
Time frame: 1. minute after spinal block
Efedrine Consumption in the first 15 minutes after the spinal block
Efedrine Consumption
Time frame: 4. minute after spinal block
Efedrine Consumption in the first 15 minutes after the spinal block
Efedrine Consumption
Time frame: 7. minute after spinal block
Efedrine Consumption in the first 15 minutes after the spinal block
Efedrine Consumption
Time frame: 9. minute after spinal block
Efedrine Consumption in the first 15 minutes after the spinal block
Efedrine Consumption
Time frame: 12. minute after spinal block
Efedrine Consumption in the first 15 minutes after the spinal block
Efedrine Consumption
Time frame: 15. minute after spinal block
Efedrine Consumption in the first 15 minutes after the spinal block
Atropine Consumption
Time frame: 1. minute after spinal block
Atropine Consumption in the first 15 minutes after the spinal block
Atropine Consumption
Time frame: 4. minute after spinal block
Atropine Consumption in the first 15 minutes after the spinal block
Atropine Consumption
Time frame: 7. minute after spinal block
Atropine Consumption in the first 15 minutes after the spinal block
Atropine Consumption
Time frame: 9. minute after spinal block
Atropine Consumption in the first 15 minutes after the spinal block
Atropine Consumption
Time frame: 12. minute after spinal block
Atropine Consumption in the first 15 minutes after the spinal block
Atropine Consumption
Time frame: 15. minute after spinal block
Atropine Consumption in the first 15 minutes after the spinal block
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 11 Oct 2023.
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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.
Akcan Akkaya, MD. principal investigator
Bolu Abant Izzet Baysal university Medical School, Anesthesiology and Reanimation D.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Slow dose preemptive Atropine and Ephedrine in people with Pregnancy and Cesarean Section, run by Abant Izzet Baysal 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 1 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 11 Oct 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Heart rate (time frame: 1. minunte after spinal block). The study lists 30 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 11 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.