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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bolus 6 micrograms Noradrenaline group | Experimental | Mothers in this group will receive a bolus of Norepinephrine 6 mcg for management of hypotensive episode after spinal anesthesia using Bupivacaine hydrochloride. |
|
| Bolus 8 micrograms Noradrenaline group | Active Comparator | Mothers in this group will receive a bolus of Norepinephrine 8 mcg for management of hypotensive episode after spinal anesthesia using Bupivacaine hydrochloride. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Noradrenaline Bitartrate | Drug | An intravenous bolus of norepinephrine 6 mcg will be administered for management of maternal hypotension. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After spinal anesthesia until the end of surgery |
| 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. | After spinal anesthesia until the end of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | After spinal anesthesia until the end of surgery |
| Incidence of bradycardia |
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Inclusion Criteria:
Exclusion Criteria:
Female patients with cesarean delivery
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| Name | Affiliation | Role |
|---|---|---|
| Levent Özdemir, Assist Prof | Mersin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mersin University | Mersin | Yenişehir | 33343 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28248702 | Background | 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. | |
| 29951531 | Background |
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|
| Bupivacaine Hydrochloride | Drug | Subarachnoid block will be performed using Bupivacaine hydrochloride (2.5 mL) |
|
|
| Noradrenaline Bitartrate | Drug | An intravenous bolus of norepinephrine 8 mcg will be administered for management of maternal hypotension. |
|
|
| Bupivacaine Hydrochloride | Drug | Subarachnoid block will be performed using Bupivacaine hydrochloride (2.5 mL) |
|
|
Patients with a heart rate less than 40 bpm |
| After spinal anesthesia until the end of surgery |
| 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. | The first 5 minutes after birth |
| Umbilical cord blood gas analyses of fetus | Potential of hydrogen (pH): Normal range is between 7.35-7.45 | The first 5 minutes after birth |
| Umbilical cord blood gas analyses of fetus | Partial arterial oxygen pressure (PaO2, mmHg): Normal range is between 50-100 mmHg | The first 5 minutes after birth |
| Umbilical cord blood gas analyses of fetus | Partial carbon dioxide pressure (PaCO2, mmHg): Normal range is between 35-45 mmHg | The first 5 minutes after birth |
| Umbilical cord blood gas analyses of fetus | Bicarbonate (HCO3, mEq/liter): Normal range is between 22-26 mEq/liter | The first 5 minutes after birth |
| Umbilical cord blood gas analyses of fetus | Base deficit (BE, mEq/liter): Normal range is between +2 to -2 mEq/liter | The first 5 minutes after birth |
| The frequency of side effects after norepinephrine | the number of patients with side effects (Nausea, vomiting, headache, tinnitus, arrhythmia, chest pain, etc.) | During surgery after spinal block |
| The frequency of side effects after subarachnoid block | Side effects seen after spinal block and in patients who have not yet received noradrenaline | During surgery after spinal block |
| 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. | Measurements just before and 1 minute after noradrenaline administration |
| 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. |
| 25654435 | Background | 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. |
| 32303180 | Result | 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. |
| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D009638 | Norepinephrine |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
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