HypotensionPhase 4NCT04701190
Different Noradrenaline Protocols in Post Spinal Hypotension in CS
A Phase 4 study testing Noradrenalin 10 microgram bolus, Noradrenaline 5 microgram bolus and Noradrenaline 0.1 microgram/kg/minute infusion in people with Hypotension and Cesarean Section, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The incidence of hypotension after spinal anesthesia is approximately 60% in parturients undergoing cesarean section. As a consequence of hypotension, nausea-vomiting, dyspnea and neurological deterioration in patients and low Apgar scores in newborns may occur. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Hypotension, Cesarean Section, Anesthesia, Spinal
- What is being tested?
- Noradrenalin 10 microgram bolus, Noradrenaline 5 microgram bolus and Noradrenaline 0.1 microgram/kg/minute infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2021to 15 Dec 2021
- 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 2
- 38 +4 gestational age parturient
Who cannot join
- ASA 3-6
- Parturients with any kind of contraindication to spinal anesthesia
- Hypertensive parturients (basal systolic blood pressure above 140 mmHg)
- Parturients having basal systolic blood pressure below 100 mmHg
- Parturients having peripartum hemorrhage
- Parturients having body mass index above 40
- Parturients with a known allergic reaction to one of the study drugs
- Parturients not willing to be included into the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Different Noradrenaline Protocols to Prevent Post Spinal Hypotension During Elective Caesarean Delivery: A Randomised, Double-blind Clinical Trial
The incidence of hypotension after spinal anesthesia is approximately 60% in parturients undergoing cesarean section. As a consequence of hypotension, nausea-vomiting, dyspnea and neurological deterioration in patients and low Apgar scores in newborns may occur. Therefore, there is an increasing interest to prevent maternal post spinal hypotension by using several drugs including noradrenaline given in different protocols to the patients undergoing spinal anesthesia for cesarean section. However, there is no conclusive answer to the question of which dosage is the best to prevent the maternal post spinal hypotension in literature.
In this prospective randomized study, we aimed to compare different noradrenaline protocols for preventing maternal post spinal hypotension during elective cesarean delivery.
Read the detailed description
One of the most important and frequent adverse effects of spinal anesthesia is post procedure hypotension. The emerging hypotension does not affect only the pregnant, it also does harm to the newborn. Therefore, an anesthesiologist should avoid and take precautions to prevent maternal post spinal hypotension. There is a growing body of evidence about noradrenalin application in the management of hemodynamic optimization of patients undergoing cesarean section with spinal anesthesia. However, there is no conclusive decision about the dosage and application protocol of noradrenaline in this patient population. In a study comparing the incidence of post spinal maternal hypotension given noradrenaline versus phenylephrine, the authors reported that both of drugs effectively controlled maternal blood pressure. The incidence of maternal hypotension was 30% and 32% (p= 0.8) in noradrenaline and phenylephrine study arms, respectively. Therefore, one can speculate that the incidence of maternal post spinal hypotension remains high even in patients receiving noradrenaline or phenylephrine. In the noradrenaline arm, only noradrenaline infusion with a dosage of 0.05 microgram/kg/minute without any bolus was applied to the patients. In another study, the effects of different noradrenaline infusion dosages with 5 microgram bolus dosage on maternal post spinal hypotension were investigated. The frequencies of maternal hypotension were 42.1%, 24.7% and 26% in patients receiving 0.025, 0.05 and 0.075 microgram/kg/minute with a bolus 5 microgram noradrenaline, respectively. As a conclusion of this study, addition of a bolus dose of 5 microgram noradrenaline may lower the incidence of post spinal hypotension. However, as in the previous study, approximately one fourth of patients still may have a post spinal hypotension episode. Regarding these results, the present study is planned to answer the question of which approach including increasing infusion or bolus dosage of noradrenaline is superior to ameliorate the incidence of hypotension in this population.
In conclusion, the aim of this study is to compare three different noradrenaline protocols including different bolus and infusion dosages to decrease the rate of hypotension in patients undergoing cesarean section with spinal anesthesia.
- Conditions
- Hypotension, Cesarean Section, Anesthesia, Spinal
- Being tested
- Noradrenalin 10 microgram bolus, Noradrenaline 5 microgram bolus, Noradrenaline 0.1 microgram/kg/minute infusion, Noradrenaline 0.05 microgram/kg/minute infusion, Infusion dosage: 0.075 microgram/kg/minute infusion
- Keywords
- Apgar Score, Pregnancy, Blood Pressure, Heart Rate, adult, female, Hypotension, Noradrenaline, Cesarean Section, Anesthesia, Spinal
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noradrenalin 10 microgram bolusDrug
Also called NA 10B
The noradrenaline bolus dosage of 10 microgram will be administered to the patient at the same time of obtaining cerebrospinal fluid running freely.
Noradrenaline 5 microgram bolusDrug
Also called NA 5B
The noradrenaline bolus dosage of 5 microgram will be administered to the patient at the same time of obtaining cerebrospinal fluid running freely.
Noradrenaline 0.1 microgram/kg/minute infusionDrug
Also called NA 0.1I
Infusion dosage: 0.1 microgram/kg/minute After the end of the injection of heavy marcaine 0.5% to the subarachnoid space, the infusion of noradrenaline with a 0.1 microgram/kg/minute dosage will be started.
Noradrenaline will be continued until 5 minutes after delivery of fetus.
Noradrenaline 0.05 microgram/kg/minute infusionDrug
Also called NA 0.05I
Infusion dosage: 0.05 microgram/kg/minute After the end of the injection of heavy marcaine 0.5% to the subarachnoid space, the infusion of noradrenaline with a 0.05 microgram/kg/minute dosage will be started.
Noradrenaline will be continued until 5 minutes after delivery of fetus.
Infusion dosage: 0.075 microgram/kg/minute infusionDrug
Also called NA 0.075I
nfusion dosage: 0.075 microgram/kg/minute After the end of the injection of heavy marcaine 0.5% to the subarachnoid space, the infusion of noradrenaline with a 0.075 microgram/kg/minute dosage will be started.
Noradrenaline will be continued until 5 minutes after delivery of fetus.
Spinal anesthesiaProcedure or surgery
Spinal anesthesia using 0.5% 10 milligram heavy bupivacaine plus 12.5 microgram fentanyl
| Study group | Role | What they receive |
|---|---|---|
| Noradrenaline 0.05/10 | Active comparator | Study drug will be prepared as follows:4 milligram noradrenaline will be administered into 100 milliliter 5% dextrose solution.
The basal blood pressure of the parturient will be recorded as an arithmetic sum of the sequential three measurements of noninvasive blood pressure.
Maternal hypotension and severe hypotension will be described as a decrease of noninvasive systolic blood pressure according to basal systolic blood pressure by 20% and 40%, respectively.
If the heart rate of parturient will be under 60 beat/minute, this will be recorded as maternal bradycardia.
The noradrenaline bolus dosage of 10 microgram will be administered to the patient at the same time of obtaining cerebrospinal fluid running freely. After the end of the injection of heavy marcaine 0.5% to the subarachnoid space, the infusion of noradrenaline with a 0.05 microgram/kg/minute dosage will be started.
Noradrenaline will be continued until 5 minutes after delivery of fetus. Receives: Drug: Noradrenalin 10 microgram bolus; Drug: Noradrenaline 0.05 microgram/kg/minute infusion; Procedure: Spinal anesthesia |
| Noradrenaline 0.075/5 | Active comparator | Study drug will be prepared as follows:4 milligram noradrenaline will be administered into 100 milliliter 5% dextrose solution.
The basal blood pressure of the parturient will be recorded as an arithmetic sum of the sequential three measurements of noninvasive blood pressure.
Maternal hypotension and severe hypotension will be described as a decrease of noninvasive systolic blood pressure according to basal systolic blood pressure by 20% and 40%, respectively.
If the heart rate of parturient will be under 60 beat/minute, this will be recorded as maternal bradycardia.
The noradrenaline bolus dosage of 5 microgram will be administered to the patient at the same time of obtaining cerebrospinal fluid running freely. After the end of the injection of heavy marcaine 0.5% to the subarachnoid space, the infusion of noradrenaline with a 0.075 microgram/kg/minute dosage will be started.
Noradrenaline will be continued until 5 minutes after delivery of fetus. Receives: Drug: Noradrenaline 5 microgram bolus; Drug: Infusion dosage: 0.075 microgram/kg/minute infusion; Procedure: Spinal anesthesia |
| Noradrenaline 0.1/0 | Active comparator | Study drug will be prepared as follows:4 milligram noradrenaline will be administered into 100 milliliter 5% dextrose solution.
The basal blood pressure of the parturient will be recorded as an arithmetic sum of the sequential three measurements of noninvasive blood pressure.
Maternal hypotension and severe hypotension will be described as a decrease of noninvasive systolic blood pressure according to basal systolic blood pressure by 20% and 40%, respectively.
If the heart rate of parturient will be under 60 beat/minute, this will be recorded as maternal bradycardia.
After the end of the injection of heavy marcaine 0.5% to the subarachnoid space, the infusion of noradrenaline with a 0.1 microgram/kg/minute without bolus dosage will be started.
Noradrenaline will be continued until 5 minutes after delivery of fetus. Receives: Drug: Noradrenaline 0.1 microgram/kg/minute infusion; Procedure: Spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of maternal post spinal hypotension
The primary outcome of this study is to compare the incidences of maternal post spinal hypotension in patients administered three different noradrenaline protocols.
Measured: Between the application time of spinal anesthesia and 5th minute after delivery
Incidence of maternal post spinal severe hypotension
The other primary outcome of this study is to compare the incidences of maternal post spinal severe hypotension in patients administered three different noradrenaline protocols.
Measured: Between the application time of spinal anesthesia and 5th minute after delivery
Secondary outcomes (3)
The incidence of post delivery maternal hypotension
The secondary outcome of this study is to compare the incidences of maternal post delivery hypotension in patients administered three different noradrenaline protocols.
Measured: Between 5th minute after delivery and the end of surgery
The incidence of post delivery maternal severe hypotension
The other secondary outcome of this study is to compare the incidences of maternal post delivery severe hypotension in patients administered three different noradrenaline protocols.
Measured: Between 5 minute of delivery and the end of surgery
The incidence of intervention applied by an anesthesiologist
The other secondary outcome is to determine and to compare the frequency of intervention applied by the anesthesiologist to stabilize the patients hemodynamic status.This interventions include changing the noradrenaline infusion status, administering atropine and ephedrine, according to the patients hemodynamic data.
Measured: Between the start of patient monitoring and the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start1 Feb 2021
- Primary completion15 Dec 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Menekse Ozcelik, Ankara University
- Investigators
- Menekse Ozcelik, M.D, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701190
- Sponsor's protocol ID
- 05
- Status last verified
- Jan 2022
- First submitted
- 6 Jan 2021
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vallejo MC, Attaallah AF, Elzamzamy OM, Cifarelli DT, Phelps AL, Hobbs GR, Shapiro RE, Ranganathan P. An open-label randomized controlled clinical trial for comparison of continuous phenylephrine versus norepinephrine infusion in prevention of spinal hypotension during cesarean delivery. Int J Obstet Anesth. 2017 Feb;29:18-25. doi: 10.1016/j.ijoa.2016.08.005. Epub 2016 Aug 28.
PubMed 27720613Hasanin AM, Amin SM, Agiza NA, Elsayed MK, Refaat S, Hussein HA, Rouk TI, Alrahmany M, Elsayad ME, Elshafaei KA, Refaie A. Norepinephrine Infusion for Preventing Postspinal Anesthesia Hypotension during Cesarean Delivery: A Randomized Dose-finding Trial. Anesthesiology. 2019 Jan;130(1):55-62. doi: 10.1097/ALN.0000000000002483.
PubMed 30335625Hasanin A, Amin S, Refaat S, Habib S, Zayed M, Abdelwahab Y, Elsayad M, Mostafa M, Raafat H, Elshall A, Fatah SAE. Norepinephrine versus phenylephrine infusion for prophylaxis against post-spinal anaesthesia hypotension during elective caesarean delivery: A randomised controlled trial. Anaesth Crit Care Pain Med. 2019 Dec;38(6):601-607. doi: 10.1016/j.accpm.2019.03.005. Epub 2019 Mar 30.
PubMed 30935897Baytas V, Karadag Erkoc S, Ozcelik M, Gokmen D, Bermede AO, Selvi Can O, Uysalel A. A Randomized, Double-Blind, Graded Dose-Response Study of Norepinephrine Administration for Prevention of Post-Spinal Hypotension during Elective Cesarean Delivery. J Clin Med. 2023 Oct 10;12(20):6437. doi: 10.3390/jcm12206437.
PubMed 37892573
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Noradrenaline Protocols to Prevent Post Spinal Hypotension During Elective Caesarean Delivery: A Randomised, Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT04701190
- Acronym / sponsor ID
- 05
- Conditions
- Hypotension, Cesarean Section, Anesthesia, Spinal
- Keywords
- Apgar Score, Pregnancy, Blood Pressure, Heart Rate, adult, female, Hypotension, Noradrenaline
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 8 Jan 2021 (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 incidence of hypotension after spinal anesthesia is approximately 60% in parturients undergoing cesarean section. As a consequence of hypotension, nausea-vomiting, dyspnea and neurological deterioration in patients and low Apgar scores in newborns may occur. Therefore, there is an increasing interest to prevent maternal post spinal hypotension by using several drugs including noradrenaline given in different protocols to the patients undergoing spinal anesthesia for cesarean section. However, there is no conclusive answer to the question of which dosage is the best to prevent the maternal post spinal hypotension in literature.
In this prospective randomized study, we aimed to compare different noradrenaline protocols for preventing maternal post spinal hypotension during elective cesarean delivery.
Detailed description
One of the most important and frequent adverse effects of spinal anesthesia is post procedure hypotension. The emerging hypotension does not affect only the pregnant, it also does harm to the newborn. Therefore, an anesthesiologist should avoid and take precautions to prevent maternal post spinal hypotension. There is a growing body of evidence about noradrenalin application in the management of hemodynamic optimization of patients undergoing cesarean section with spinal anesthesia. However, there is no conclusive decision about the dosage and application protocol of noradrenaline in this patient population. In a study comparing the incidence of post spinal maternal hypotension given noradrenaline versus phenylephrine, the authors reported that both of drugs effectively controlled maternal blood pressure. The incidence of maternal hypotension was 30% and 32% (p= 0.8) in noradrenaline and phenylephrine study arms, respectively. Therefore, one can speculate that the incidence of maternal post spinal hypotension remains high even in patients receiving noradrenaline or phenylephrine. In the noradrenaline arm, only noradrenaline infusion with a dosage of 0.05 microgram/kg/minute without any bolus was applied to the patients. In another study, the effects of different noradrenaline infusion dosages with 5 microgram bolus dosage on maternal post spinal hypotension were investigated. The frequencies of maternal hypotension were 42.1%, 24.7% and 26% in patients receiving 0.025, 0.05 and 0.075 microgram/kg/minute with a bolus 5 microgram noradrenaline, respectively. As a conclusion of this study, addition of a bolus dose of 5 microgram noradrenaline may lower the incidence of post spinal hypotension. However, as in the previous study, approximately one fourth of patients still may have a post spinal hypotension episode. Regarding these results, the present study is planned to answer the question of which approach including increasing infusion or bolus dosage of noradrenaline is superior to ameliorate the incidence of hypotension in this population.
In conclusion, the aim of this study is to compare three different noradrenaline protocols including different bolus and infusion dosages to decrease the rate of hypotension in patients undergoing cesarean section with spinal anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Noradrenaline 0.05/10 | Active comparator | Drug: Noradrenalin 10 microgram bolus, Drug: Noradrenaline 0.05 microgram/kg/minute infusion, Procedure: Spinal anesthesiaStudy drug will be prepared as follows:4 milligram noradrenaline will be administered into 100 milliliter 5% dextrose solution. The basal blood pressure of the parturient will be recorded as an arithmetic sum of the sequential three measurements of noninvasive blood pressure. Maternal hypotension and severe hypotension will be described as a decrease of noninvasive systolic blood pressure according to basal systolic blood pressure by 20% and 40%, respectively. If the heart rate of parturient will be under 60 beat/minute, this will be recorded as maternal bradycardia. The noradrenaline bolus dosage of 10 microgram will be administered to the patient at the same time of obtaining cerebrospinal fluid running freely. After the end of the injection of heavy marcaine 0.5% to the subarachnoid space, the infusion of noradrenaline with a 0.05 microgram/kg/minute dosage will be started. Noradrenaline will be continued until 5 minutes after delivery of fetus. |
| Noradrenaline 0.075/5 | Active comparator | Drug: Noradrenaline 5 microgram bolus, Drug: Infusion dosage: 0.075 microgram/kg/minute infusion, Procedure: Spinal anesthesiaStudy drug will be prepared as follows:4 milligram noradrenaline will be administered into 100 milliliter 5% dextrose solution. The basal blood pressure of the parturient will be recorded as an arithmetic sum of the sequential three measurements of noninvasive blood pressure. Maternal hypotension and severe hypotension will be described as a decrease of noninvasive systolic blood pressure according to basal systolic blood pressure by 20% and 40%, respectively. If the heart rate of parturient will be under 60 beat/minute, this will be recorded as maternal bradycardia. The noradrenaline bolus dosage of 5 microgram will be administered to the patient at the same time of obtaining cerebrospinal fluid running freely. After the end of the injection of heavy marcaine 0.5% to the subarachnoid space, the infusion of noradrenaline with a 0.075 microgram/kg/minute dosage will be started. Noradrenaline will be continued until 5 minutes after delivery of fetus. |
| Noradrenaline 0.1/0 | Active comparator | Drug: Noradrenaline 0.1 microgram/kg/minute infusion, Procedure: Spinal anesthesiaStudy drug will be prepared as follows:4 milligram noradrenaline will be administered into 100 milliliter 5% dextrose solution. The basal blood pressure of the parturient will be recorded as an arithmetic sum of the sequential three measurements of noninvasive blood pressure. Maternal hypotension and severe hypotension will be described as a decrease of noninvasive systolic blood pressure according to basal systolic blood pressure by 20% and 40%, respectively. If the heart rate of parturient will be under 60 beat/minute, this will be recorded as maternal bradycardia. After the end of the injection of heavy marcaine 0.5% to the subarachnoid space, the infusion of noradrenaline with a 0.1 microgram/kg/minute without bolus dosage will be started. Noradrenaline will be continued until 5 minutes after delivery of fetus. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA 2
- 38 +4 gestational age parturient
Key exclusion criteria (8 listed)
- ASA 3-6
- Parturients with any kind of contraindication to spinal anesthesia
- Hypertensive parturients (basal systolic blood pressure above 140 mmHg)
- Parturients having basal systolic blood pressure below 100 mmHg
- Parturients having peripartum hemorrhage
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 |
|---|---|---|
| Noradrenalin 10 microgram bolusAlso: NA 10BThe noradrenaline bolus dosage of 10 microgram will be administered to the patient at the same time of obtaining cerebrospinal fluid running freely. | Drug | Noradrenaline 0.05/10 |
| Noradrenaline 5 microgram bolusAlso: NA 5BThe noradrenaline bolus dosage of 5 microgram will be administered to the patient at the same time of obtaining cerebrospinal fluid running freely. | Drug | Noradrenaline 0.075/5 |
| Noradrenaline 0.1 microgram/kg/minute infusionAlso: NA 0.1IInfusion dosage: 0.1 microgram/kg/minute After the end of the injection of heavy marcaine 0.5% to the subarachnoid space, the infusion of noradrenaline with a 0.1 microgram/kg/minute dosage will be started. Noradrenaline will be continued until 5 minutes after delivery of fetus. | Drug | Noradrenaline 0.1/0 |
| Noradrenaline 0.05 microgram/kg/minute infusionAlso: NA 0.05IInfusion dosage: 0.05 microgram/kg/minute After the end of the injection of heavy marcaine 0.5% to the subarachnoid space, the infusion of noradrenaline with a 0.05 microgram/kg/minute dosage will be started. Noradrenaline will be continued until 5 minutes after delivery of fetus. | Drug | Noradrenaline 0.05/10 |
| Infusion dosage: 0.075 microgram/kg/minute infusionAlso: NA 0.075Infusion dosage: 0.075 microgram/kg/minute After the end of the injection of heavy marcaine 0.5% to the subarachnoid space, the infusion of noradrenaline with a 0.075 microgram/kg/minute dosage will be started. Noradrenaline will be continued until 5 minutes after delivery of fetus. | Drug | Noradrenaline 0.075/5 |
| Spinal anesthesiaSpinal anesthesia using 0.5% 10 milligram heavy bupivacaine plus 12.5 microgram fentanyl | Procedure or surgery | Noradrenaline 0.05/10, Noradrenaline 0.075/5, Noradrenaline 0.1/0 |
Primary outcome
Incidence of maternal post spinal hypotension
Time frame: Between the application time of spinal anesthesia and 5th minute after delivery
The primary outcome of this study is to compare the incidences of maternal post spinal hypotension in patients administered three different noradrenaline protocols.
Incidence of maternal post spinal severe hypotension
Time frame: Between the application time of spinal anesthesia and 5th minute after delivery
The other primary outcome of this study is to compare the incidences of maternal post spinal severe hypotension in patients administered three different noradrenaline protocols.
3 secondary outcomes
The incidence of post delivery maternal hypotension
Time frame: Between 5th minute after delivery and the end of surgery
The incidence of post delivery maternal severe hypotension
Time frame: Between 5 minute of delivery and the end of surgery
The incidence of intervention applied by an anesthesiologist
Time frame: Between the start of patient monitoring and the end of surgery
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 1 Feb 2022.
- Background: PubMed 27720613Vallejo MC, Attaallah AF, Elzamzamy OM, Cifarelli DT, Phelps AL, Hobbs GR, Shapiro RE, Ranganathan P. An open-label randomized controlled clinical trial for comparison of continuous phenylephrine versus norepinephrine infusion in prevention of spinal hypotension during cesarean delivery. Int J Obstet Anesth. 2017 Feb;29:18-25. doi: 10.1016/j.ijoa.2016.08.005. Epub 2016 Aug 28.
- Background: PubMed 30335625Hasanin AM, Amin SM, Agiza NA, Elsayed MK, Refaat S, Hussein HA, Rouk TI, Alrahmany M, Elsayad ME, Elshafaei KA, Refaie A. Norepinephrine Infusion for Preventing Postspinal Anesthesia Hypotension during Cesarean Delivery: A Randomized Dose-finding Trial. Anesthesiology. 2019 Jan;130(1):55-62. doi: 10.1097/ALN.0000000000002483.
- Background: PubMed 30935897Hasanin A, Amin S, Refaat S, Habib S, Zayed M, Abdelwahab Y, Elsayad M, Mostafa M, Raafat H, Elshall A, Fatah SAE. Norepinephrine versus phenylephrine infusion for prophylaxis against post-spinal anaesthesia hypotension during elective caesarean delivery: A randomised controlled trial. Anaesth Crit Care Pain Med. 2019 Dec;38(6):601-607. doi: 10.1016/j.accpm.2019.03.005. Epub 2019 Mar 30.
- Derived from this study: PubMed 37892573Baytas V, Karadag Erkoc S, Ozcelik M, Gokmen D, Bermede AO, Selvi Can O, Uysalel A. A Randomized, Double-Blind, Graded Dose-Response Study of Norepinephrine Administration for Prevention of Post-Spinal Hypotension during Elective Cesarean Delivery. J Clin Med. 2023 Oct 10;12(20):6437. doi: 10.3390/jcm12206437.
- 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.
Menekse Ozcelik, M.D principal investigator
Associate Professor
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 Noradrenalin 10 microgram bolus, Noradrenaline 5 microgram bolus and Noradrenaline 0.1 microgram/kg/minute infusion in people with Hypotension and Cesarean Section, run by Ankara 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 2 inclusion and 8 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 1 Feb 2022. 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?
Incidence of maternal post spinal hypotension (time frame: Between the application time of spinal anesthesia and 5th minute after delivery). 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?
On the ClinicalTrials.gov record for NCT04701190, which also lists 4 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 1 Feb 2022.