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

NCT05502146 | Completed Phase 4

• 1 other identifier: 2022/05
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Anesthetic Toxicity; Hypotension Drug-Induced; Cesarean Section Complications

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (11)

• Incidence of reactive hypertension

  After spinal anesthesia until the end of surgery

• Incidence of bradycardia

  After spinal anesthesia until the end of surgery

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

  The first 5 minutes after birth

• Umbilical cord blood gas analyses of fetus

  The first 5 minutes after birth

• Umbilical cord blood gas analyses of fetus

  The first 5 minutes after birth

Study Arms (2)

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.

Drug: Noradrenaline Bitartrate; Drug: 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.

Drug: Noradrenaline Bitartrate; Drug: Bupivacaine Hydrochloride

Interventions

Noradrenaline Bitartrate DRUG

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

Also known as: Stenor

Bolus 6 micrograms Noradrenaline group

Bupivacaine Hydrochloride DRUG

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

Also known as: Marcaine Spinal Heavy

Bolus 6 micrograms Noradrenaline group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Female patients with cesarean delivery
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Woman,
• ASA I-II,
• 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
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University

Mersin, Yenişehir, 33343, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 28248702 BACKGROUND

• 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.

  PMID: 29951531 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.

  PMID: 25654435 BACKGROUND

• 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.

  PMID: 32303180 RESULT

MeSH Terms

Conditions

Hypotension

Interventions

Norepinephrine; Bupivacaine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Anilides; Amides; Aniline Compounds

Study Officials

• Levent Özdemir, Assist Prof

  Mersin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 16, 2022
• Study Start: August 17, 2022
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)