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Spinal Anesthetic ToxicityPhase 4NCT05502146

Comparison of Two Different Norepinephrine Bolus Doses for Management of Spinal Anesthesia-Induced Maternal Hypotension

A Phase 4 study testing Noradrenaline Bitartrate and Bupivacaine Hydrochloride in people with Spinal Anesthetic Toxicity and Hypotension Drug-Induced, run by Mersin University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this study the investigators will compare two doses of norepinephrine bolus (6 mcg and 8 mcg) in management of maternal hypotensive episode after spinal block during cesarean delivery. Read more about this study

Who is it for?
Ages 18 to 49 years, women onlyHealthy volunteers can take part
What is being tested?
Noradrenaline Bitartrate and Bupivacaine Hydrochloride
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteTurkey (Türkiye)
Study dates
17 Aug 2022to 1 Oct 2022
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 49 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Woman,
  • ASA I-II,
  • 18-49 age range,
  • Actual body weight >50 kg,<90 kg
  • Actual height >150cm, <180cm
  • Patients undergoing surgery under elective conditions and emergency cases for non-bleeding reasons
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  • Fasting period is appropriate,
  • Term pregnancy (38-42 weeks),
  • Patients without cardiovascular disease
  • Spinal block that does not reach the high level (<T4),
  • Patients without diagnosis of stage 2 or higher hypertension hypertension (Stage 2 hypertension is defined as a systolic blood pressure of more than 160 mmHg and a diastolic blood pressure of more than 90 mmHg.),
  • Patients without vasoactive drug use,
  • Preop Systolic Blood Pressure >90 mmHg,
  • Bleeding less than 750 ml,
  • Patients who signed the informed consent form to be included in the study

Who cannot join

  • ASA III-IV,
  • Pregnant women outside the age range of 18-49,
  • Actual body weight >90kg, <50kg
  • Actual height >180cm, <150cm
  • Patients with inappropriate fasting time
  • Preterm pregnancy (<38 weeks) or postterm pregnancy (>42 weeks)
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  • Bleeding amount more than 750 ml
  • Emergency surgery with bleeding (previa, placental abruption, etc.)- Pregnant with cardiovascular system disease,
  • High block level (>T4)
  • Having a diagnosis of stage 2 or higher hypertension hypertension (Stage 2 hypertension is defined as a systolic blood pressure of more than 160 mmHg and a diastolic blood pressure of more than 90 mmHg.),
  • Use of vasoactive drugs,
  • Preop Systolic Blood Pressure <90 mmHg
  • Patients who did not sign the informed consent form to be included in the study

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Mersin University

    Mersin, Yenişehir, 33343

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Two Different Norepinephrine Bolus Doses for Management of Spinal Anesthesia-Induced Hypotension in Cesarean Section: A Randomized Controlled Study

In this study the investigators will compare two doses of norepinephrine bolus (6 mcg and 8 mcg) in management of maternal hypotensive episode after spinal block during cesarean delivery.

Read the detailed description

Maternal hypotension after spinal anesthesia is a common and serious complication during cesarean delivery. Despite all preventive measures, the incidence of hypotension is still around 20%. In these cases, maternal hypotension treatment is usually required using vasopressor boluses. One of the vasopressors commonly used during cesarean delivery is norepinephrine, especially recently.

Although phenylephrine has long been the first choice for the prevention and treatment of maternal hypotension, its use may cause bradycardia and decreased maternal cardiac output.

Norepinephrine is an alpha adrenergic agonist with weak beta adrenergic agonistic activity; therefore, it does not cause significant cardiac depression like phenylephrine. Norepinephrine has been introduced for use during cesarean delivery with promising results. Several previous studies have investigated the efficacy of norepinephrine infusion in preventing maternal hypotension. A dose-response study investigated the best dose of Norepinephrine for the prevention of hypotension. In the dose-response study mentioned above, a dose of 6 mcg was reported as the best dose for prophylaxis against hypotension.

There are very limited studies investigating the best bolus dose of norepinephrine for the treatment of maternal hypotensive episode, and the optimal dose recommendation is uncertain. In this study, researchers will investigate the efficacy and adverse effects of two bolus doses of norepinephrine (6 mcg and 8 mcg) in the management of a maternal hypotensive episode after subarachnoid block during cesarean delivery.

Being tested
Noradrenaline Bitartrate, Bupivacaine Hydrochloride
Medical subject headings
Hypotension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Noradrenaline BitartrateDrug

    Also called Stenor

    An intravenous bolus of norepinephrine 6 mcg will be administered for management of maternal hypotension.

  • Bupivacaine HydrochlorideDrug

    Also called Marcaine Spinal Heavy

    Subarachnoid block will be performed using Bupivacaine hydrochloride (2.5 mL)

  • Noradrenaline BitartrateDrug

    Also called Stenor

    An intravenous bolus of norepinephrine 8 mcg will be administered for management of maternal hypotension.

  • Bupivacaine HydrochlorideDrug

    Also called Marcaine Spinal Heavy

    Subarachnoid block will be performed using Bupivacaine hydrochloride (2.5 mL)

Study groups in NCT05502146
Study groupRoleWhat they receive
Bolus 6 micrograms Noradrenaline groupExperimentalMothers in this group will receive a bolus of Norepinephrine 6 mcg for management of hypotensive episode after spinal anesthesia using Bupivacaine hydrochloride.
Receives: Drug: Noradrenaline Bitartrate; Drug: Bupivacaine Hydrochloride
Bolus 8 micrograms Noradrenaline groupActive comparatorMothers in this group will receive a bolus of Norepinephrine 8 mcg for management of hypotensive episode after spinal anesthesia using Bupivacaine hydrochloride.
Receives: Drug: Noradrenaline Bitartrate; Drug: Bupivacaine Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of successful management of maternal hypotension

    Number of patients with successful management of a maternal hypotensive episode (defined as systolic blood pressure greater than 80% of baseline measurement and systolic blood pressure greater than 90 mmHg) Successful management is considered to be successful management if blood pressure does not fall below 90 mmHg and 80% of baseline measurement within 6 minutes after norepinephrine administration after hypotension develops.

    Measured: After spinal anesthesia until the end of surgery

  2. Number of Noradrenaline doses administered and total dose amount

    Evaluation of the number of bolus noradrenaline doses and the total dose required for the treatment of maternal hypotension after spinal block.

    Measured: After spinal anesthesia until the end of surgery

Secondary outcomes (11)

  1. Incidence of reactive hypertension

    Number of patients with reactive hypertension (defined as systolic blood pressure ≥120% from the baseline reading after administration of norepinephrine bolus).

    Measured: After spinal anesthesia until the end of surgery

  2. Incidence of bradycardia

    Patients with a heart rate less than 40 bpm

    Measured: After spinal anesthesia until the end of surgery

  3. Evaluation of "Appearance, Pulse, Grimace, Activity, and Respiration" (APGAR) score

    The minimum score that can be obtained from this scale is 0 and the maximum is 10 points.

    Scoring will be calculated at 1 and 5 minutes immediately after birth. A score of 9 to 10 is consistent with a better clinical outcome, while a score of 8 or less will be considered a poor clinical outcome.

    Measured: The first 5 minutes after birth

  4. Umbilical cord blood gas analyses of fetus

    Potential of hydrogen (pH): Normal range is between 7.35-7.45

    Measured: The first 5 minutes after birth

  5. Umbilical cord blood gas analyses of fetus

    Partial arterial oxygen pressure (PaO2, mmHg): Normal range is between 50-100 mmHg

    Measured: The first 5 minutes after birth

  6. Umbilical cord blood gas analyses of fetus

    Partial carbon dioxide pressure (PaCO2, mmHg): Normal range is between 35-45 mmHg

    Measured: The first 5 minutes after birth

  7. Umbilical cord blood gas analyses of fetus

    Bicarbonate (HCO3, mEq/liter): Normal range is between 22-26 mEq/liter

    Measured: The first 5 minutes after birth

  8. Umbilical cord blood gas analyses of fetus

    Base deficit (BE, mEq/liter): Normal range is between +2 to -2 mEq/liter

    Measured: The first 5 minutes after birth

  9. The frequency of side effects after norepinephrine

    the number of patients with side effects (Nausea, vomiting, headache, tinnitus, arrhythmia, chest pain, etc.)

    Measured: During surgery after spinal block

  10. The frequency of side effects after subarachnoid block

    Side effects seen after spinal block and in patients who have not yet received noradrenaline

    Measured: During surgery after spinal block

  11. Effect of noradrenaline on heart rate variability

    Comparison of the rates of change in heart rate in measurements before and after two different bolus doses of noradrenaline.

    Measured: Measurements just before and 1 minute after noradrenaline administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2022
  2. Study start17 Aug 2022
  3. Primary completion1 Oct 2022
  4. Study completion1 Oct 2022

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05502146
Sponsor's protocol ID
2022/05
Status last verified
Jan 2023
First submitted
10 Aug 2022
Last updated
18 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Onwochei DN, Ngan Kee WD, Fung L, Downey K, Ye XY, Carvalho JCA. Norepinephrine Intermittent Intravenous Boluses to Prevent Hypotension During Spinal Anesthesia for Cesarean Delivery: A Sequential Allocation Dose-Finding Study. Anesth Analg. 2017 Jul;125(1):212-218. doi: 10.1213/ANE.0000000000001846.

    PubMed 28248702

  • Chen D, Qi X, Huang X, Xu Y, Qiu F, Yan Y, Li Y. Efficacy and Safety of Different Norepinephrine Regimens for Prevention of Spinal Hypotension in Cesarean Section: A Randomized Trial. Biomed Res Int. 2018 May 23;2018:2708175. doi: 10.1155/2018/2708175. eCollection 2018.

    PubMed 29951531

  • Carvalho B, Dyer RA. Norepinephrine for Spinal Hypotension during Cesarean Delivery: Another Paradigm Shift? Anesthesiology. 2015 Apr;122(4):728-30. doi: 10.1097/ALN.0000000000000602. No abstract available.

    PubMed 25654435

  • Hassabelnaby YS, Hasanin AM, Adly N, Mostafa MMA, Refaat S, Fouad E, Elsonbaty M, Hussein HA, Mahmoud M, Abdelwahab YM, Elsakka A, Amin SM. Comparison of two Norepinephrine rescue bolus for Management of Post-spinal Hypotension during Cesarean Delivery: a randomized controlled trial. BMC Anesthesiol. 2020 Apr 17;20(1):84. doi: 10.1186/s12871-020-01004-y.

    PubMed 32303180

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Noradrenaline Bitartrate and Bupivacaine Hydrochloride in people with Spinal Anesthetic Toxicity and Hypotension Drug-Induced, run by Mersin 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 15 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: finished, as of the sponsor's last update on 18 Jan 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?

Rate of successful management of maternal hypotension (time frame: After spinal anesthesia until 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?

On the ClinicalTrials.gov record for NCT05502146, 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 18 Jan 2023.

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