Spinal AnesthesiaPhase 4NCT03163914
Effect of Vasopressors on Spinal Anaesthesia Induced Hypotension
A Phase 4 study testing Epinephrine, Norepinephrine and Phenylephrine in people with Spinal Anesthesia, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
160 pregnant patients will be enrolled in this study. Participants will divide in to 4 groups. Spinal anaesthesia will perform with 5% marcain heavy 2 ml+20 microgram fentanyl to the all patients. After performed spinal anaesthesia, vasopressor infusion will be started intravenously. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Spinal Anesthesia
- What is being tested?
- Epinephrine, Norepinephrine and Phenylephrine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jul 2017to 24 Apr 2018
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA I-II physical status
- Pregnant patients
- Full term pregnant
Who cannot join
- ASA III-IV physical status
- Emergency status
- Heart disease
- Hypertension
- Body mass index>25
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Çukurova University Balcalı Hospital
Adana, 01380
About this study
Official title: Comparison of the Effect of Epinephrine, Norepinephrine and Phenylephrine on Spinal Anesthesia Induced Hypotension
160 pregnant patients will be enrolled in this study. Participants will divide in to 4 groups. Spinal anaesthesia will perform with 5% marcain heavy 2 ml+20 microgram fentanyl to the all patients. After performed spinal anaesthesia, vasopressor infusion will be started intravenously. Epinephrine will prepare 5 mg/ml and infusion rate will adjust 30 ml/h for Group E. Norepinephrine will prepare 5 mg/ml and infusion rate will adjust 30 ml/h for Group NE and 0.9% saline (group S) was launched immediately after induction of spinal anesthesia. Phenylephrine will prepare 100 microg/ml and infusion rate will adjust 30 ml/h for Group P. If systolic blood pressure decrease 20% of basal value or below to 100 mmHg, bolus ephedrine will apply intravenously (IV). If heart rate will decrease 60 beat per min or 20% of basal value, atropine will apply IV.
Read the detailed description
After approved informed consent, 160 pregnant (term) patients with American society of anaesthesiologist (ASA) physiological status I-II will include this prospective, randomized clinical study. For randomisation of participants, computerized randomisation programme will use and they will divide into 4 groups. Basal value of systolic blood pressure(SBP) and heart rate (HR) will calculate with mean of the measure of 3 time SBP and HR before spinal anaesthesia. Spinal anaesthesia will perform with 5% marcain heavy 2 ml+20 microgram fentanyl at the point of lumbar 3-4 or 4-5 interspinous space to the all patients. After performed spinal anaesthesia, vasopressor infusion will start intravenously. Epinephrine, norepinephrine and phenylephrine will use for vasopressor infusion. Epinephrine will prepare 5 mg/ml and infusion rate will adjust 30 ml/h for Group E. Norepinephrine will prepare 5 mg/ml and infusion rate will adjust 30 ml/h for Group NE. Phenylephrine will prepare 100 microg/ml and infusion rate will adjust 30 ml/h for Group P. salin infusion will launch 30 ml/h for group Salin. If systolic blood pressure decrease 20% of basal value or below to 100 mmHg, bolus ephedrine will apply intravenously (IV) for rescue drug. If heart rate will decrease 60 beat per min or 20% of basal value, atropine will apply IV.
At the end of the study all collected data will use for statistically analysis.
- Conditions
- Spinal Anesthesia
- Being tested
- Epinephrine, Norepinephrine, Phenylephrine, Saline
- Keywords
- vasopressor, spinal anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpinephrineDrug
Also called group I
Epinephrine infusion rate will adjust 30 ml/h (5µg/ ml )
NorepinephrineDrug
Also called group II
Norepinephrine infusion rate will adjust 30 ml/h (5µg/ ml )
PhenylephrineDrug
Also called group III
Phenylephrine infusion rate will adjust 30 ml/h (100µg/ ml )
SalineDrug
Also called group IV
saline infusion will apply till the end of the surgery
| Study group | Role | What they receive |
|---|---|---|
| Epinephrine | Active comparator | Epinephrine will prepare as 5µg/ ml and epinephrine infusion rate will adjust 30 ml/h. Receives: Drug: Epinephrine |
| Norepinephrine | Active comparator | Norepinephrine will prepare as 5µg/ ml and epinephrine infusion rate will adjust 30 ml/h. Receives: Drug: Norepinephrine |
| Phenylephrine | Active comparator | Phenylephrine will prepare as 100 µg/ ml and phenylephrine infusion rate will adjust 30 ml/h. Receives: Drug: Phenylephrine |
| Control | Placebo comparator | Saline infusion will apply at equivalent volume till the surgical operation Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intraoperative maternal hypotension
The incidence of hypotension (described as less than 80% of baseline (prenatal) SBP or SBP <90 mm Hg), the total number of hypotension episodes during surgery
Measured: At the time from start of vasopressor infusion till the end of surgery. The time frame is approximately 1 hour, peroperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start19 Jul 2017
- Primary completion24 Apr 2018
- Study completion24 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ebru biricik, Cukurova University
- Investigators
- Hakkı Ünlügenç, Study director, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163914
- Sponsor's protocol ID
- Vasopressor
- Status last verified
- Nov 2017
- First submitted
- 11 May 2017
- Last updated
- 24 Oct 2019
- Results posted
- No
- Data monitoring committee
- 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 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Epinephrine, Norepinephrine and Phenylephrine on Spinal Anesthesia Induced Hypotension
- ClinicalTrials.gov ID
- NCT03163914
- Acronym / sponsor ID
- Vasopressor
- Conditions
- Spinal Anesthesia
- Keywords
- vasopressor, spinal anaesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 19 Jul 2017 (actual)
- Primary completion
- 24 Apr 2018 (actual)
- Study completion
- 24 Apr 2018 (actual)
- First posted
- 23 May 2017 (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.
160 pregnant patients will be enrolled in this study. Participants will divide in to 4 groups. Spinal anaesthesia will perform with 5% marcain heavy 2 ml+20 microgram fentanyl to the all patients. After performed spinal anaesthesia, vasopressor infusion will be started intravenously. Epinephrine will prepare 5 mg/ml and infusion rate will adjust 30 ml/h for Group E. Norepinephrine will prepare 5 mg/ml and infusion rate will adjust 30 ml/h for Group NE and 0.9% saline (group S) was launched immediately after induction of spinal anesthesia. Phenylephrine will prepare 100 microg/ml and infusion rate will adjust 30 ml/h for Group P. If systolic blood pressure decrease 20% of basal value or below to 100 mmHg, bolus ephedrine will apply intravenously (IV). If heart rate will decrease 60 beat per min or 20% of basal value, atropine will apply IV.
Detailed description
After approved informed consent, 160 pregnant (term) patients with American society of anaesthesiologist (ASA) physiological status I-II will include this prospective, randomized clinical study. For randomisation of participants, computerized randomisation programme will use and they will divide into 4 groups. Basal value of systolic blood pressure(SBP) and heart rate (HR) will calculate with mean of the measure of 3 time SBP and HR before spinal anaesthesia. Spinal anaesthesia will perform with 5% marcain heavy 2 ml+20 microgram fentanyl at the point of lumbar 3-4 or 4-5 interspinous space to the all patients. After performed spinal anaesthesia, vasopressor infusion will start intravenously. Epinephrine, norepinephrine and phenylephrine will use for vasopressor infusion. Epinephrine will prepare 5 mg/ml and infusion rate will adjust 30 ml/h for Group E. Norepinephrine will prepare 5 mg/ml and infusion rate will adjust 30 ml/h for Group NE. Phenylephrine will prepare 100 microg/ml and infusion rate will adjust 30 ml/h for Group P. salin infusion will launch 30 ml/h for group Salin. If systolic blood pressure decrease 20% of basal value or below to 100 mmHg, bolus ephedrine will apply intravenously (IV) for rescue drug. If heart rate will decrease 60 beat per min or 20% of basal value, atropine will apply IV.
At the end of the study all collected data will use for statistically analysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Epinephrine | Active comparator | Drug: EpinephrineEpinephrine will prepare as 5µg/ ml and epinephrine infusion rate will adjust 30 ml/h. |
| Norepinephrine | Active comparator | Drug: NorepinephrineNorepinephrine will prepare as 5µg/ ml and epinephrine infusion rate will adjust 30 ml/h. |
| Phenylephrine | Active comparator | Drug: PhenylephrinePhenylephrine will prepare as 100 µg/ ml and phenylephrine infusion rate will adjust 30 ml/h. |
| Control | Placebo comparator | Drug: SalineSaline infusion will apply at equivalent volume till the surgical operation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA I-II physical status
- Pregnant patients
- Full term pregnant
Key exclusion criteria (5 listed)
- ASA III-IV physical status
- Emergency status
- Heart disease
- Hypertension
- Body mass index>25
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 |
|---|---|---|
| EpinephrineAlso: group IEpinephrine infusion rate will adjust 30 ml/h (5µg/ ml ) | Drug | Epinephrine |
| NorepinephrineAlso: group IINorepinephrine infusion rate will adjust 30 ml/h (5µg/ ml ) | Drug | Norepinephrine |
| PhenylephrineAlso: group IIIPhenylephrine infusion rate will adjust 30 ml/h (100µg/ ml ) | Drug | Phenylephrine |
| SalineAlso: group IVsaline infusion will apply till the end of the surgery | Drug | Control |
Primary outcome
Incidence of intraoperative maternal hypotension
Time frame: At the time from start of vasopressor infusion till the end of surgery. The time frame is approximately 1 hour, peroperatively.
The incidence of hypotension (described as less than 80% of baseline (prenatal) SBP or SBP <90 mm Hg), the total number of hypotension episodes during 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 24 Oct 2019.
- 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.
Hakkı Ünlügenç study director
Cukurova University
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 Epinephrine, Norepinephrine and Phenylephrine in people with Spinal Anesthesia, run by Cukurova 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 5 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 24 Oct 2019. 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. Some participants in this study may receive a placebo. 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 intraoperative maternal hypotension (time frame: At the time from start of vasopressor infusion till the end of surgery. The time frame is approximately 1 hour, peroperatively.). 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 24 Oct 2019.