Management of Postspinal Anesthesia Hypotension During Elective Cesarean Section: Baby Norepinephrine Versus Ephedrine

NCT06498076 | Completed

• 1 other identifier: HCharlesNicolle
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

Background : Spinal anesthesia emerges as the preferred anesthesia technique for elective cesarean section . It offers a preferable alternative to general anesthesia because it provides better maternal safety and neonatal outcomes. However, spinal anesthesia is not free of inherent risks. Hypotension remains the most common complication which threats both mother and child. The common method of treating hypotension includes fluid loading and the use of vasopressors such as ephedrine and phenylephrine. One promising approach is the administration of diluted norepinephrine. It presents a good alternative to preserve maternal blood pressure while minimizing adverse effects on the mother and fetus. Thus, our study proposes to evaluate the efficacy and safety of diluted norepinephrine boluses compared with ephedrine on the management of post- spinal anesthesia hypotension during scheduled cesarean sections. Patients and methods : After local Ethical Commitee approval, this prospective randomized double -blind study will be undertaken from August to October 2024 in the Department of Anesthesiology and Intensive care and Gynecology and Obstetric department of Charles Nicolle Hospital of Tunis. After obtaining informed written consent, singleton full-term pregnant females of ASA grade II, aged 18-38 years, scheduled for elective cesarean section under spinal anesthesia will be randomly divided into two groups. Group N : patients receive norepinephrine boluses (8 µg) ; prophylactic bolus immediately after spinal anesthesia induction and therapeutic boluses when systolic blood pressure falls to ≤ 20% of baseline. Group E : parturients receive ephedrine boluses (6 mg) ; systematic bolus after the induction of spinal anesthesia and therapeutic boluses if hypotension. Heart rate, systolic, diastolic and mean blood pressure are monitored. Number of episodes of hypotension and number of vasopressor boluses used in each group are recorded and considered as the primary outcomes of the study. Complication during the surgery as incidence of hypertension, tachycardia, bradycardia, nausea and vomiting are recorded. We also record neonatal APGAR score at 1 minute and five minutes. These parameters are considered as the secondary outcomes of the study. Statistical study: Data entry and analysis will be performed by SPSS software version 25.0. We will use Excel 2019 software to edit the charts. Continuous quantitative variables following a normal distribution will be expressed by their means and standard deviation. Categorical variables will be expressed as frequencies and percentages. Analytical study: We'll use the Pearson chi2 test or Fischer's exact test, whichever appropriate, for the comparison of categorical variables. T test of Student and Mann Whitney U-test will be employed for comparing Continuous variables. We 'll retain a significance threshold for p less than 5%.

Conditions

Anesthesia Complication; Vasopressor; Cesarean Section Complications; Hypotension During Surgery

Keywords

spinal anesthesia; cesarean section; complications; hypotension; ephedrine; norepinehrine

Outcome Measures

Primary Outcomes (1)

• number of boluses of vasopressor during surgery

  number of boluses of norepinephrine in Group N and number of boluses of ephedrine in Group E, to maintain systolic blood pressure more than 80% of the baseline

  number of boluses in the first hour after spinal anesthesia

Secondary Outcomes (5)

• Incidence of hypertension

  number of hypertension in the first hour after spinal anesthesia

• Incidence of tachycardia

  number of tachycardia in the first hour after spinal anesthesia

• Incidence of bradycardia

  number of bradycardia in the first hour after spinal anesthesia

• Incidence of nausea and vomiting

  the first hour after spinal anesthesia

• Neonatal APGAR score

  the first hour

Study Arms (2)

Group E: ephedrine

ACTIVE COMPARATOR

Group E : parturients will received ephedrine boluses (6 mg) ; systematic bolus after the induction of spinal anesthesia and therapeutic boluses if hypotention (systolic blood pressure falls to ≤ 20% of baseline).

Drug: Ephedrine

Group N: norepinephrine

ACTIVE COMPARATOR

Group N : patients will received norepinephrine boluses (8 µg) ; prophylactic bolus immediately after spinal anesthesia induction and therapeutic boluses when systolic blood pressure falls to ≤ 20% of baseline

Drug: Norepinephrine

Interventions

Norepinephrine DRUG

injection of prophylactic norepinephrinebolus after spinal anesthesia induction. If hypotension at any time during surgery, administration of rescue bolus of the same vasopressor to each patient.

Also known as: Group N

Group N: norepinephrine

Ephedrine DRUG

injection of prophylactic ephedrine If hypotension at any time during surgery, administration of rescue bolus of the same vasopressor to each patient.

Also known as: Group E

Group E: ephedrine

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton full-term consenting pregnant females of ASA grade II, aged 18-38 years, scheduled for elective cesarean section under spinal anesthesia

You may not qualify if:

• Any parturient falling in the category ASA grade III and IV, contrindications to spinal anesthesia, preeclampsia, chronic hypertension, comorbidity with diabetes mellitus, cardiovascular disorders and psychiatric illness are non included.
• They are excluded the case of failure of spinal anesthesia, conversion to general anesthesia, post-partum bleeding, and failure to follow protocol.

Sponsors & Collaborators

• Hopital Charles Nicolle: lead

Study Sites (1)

Charles Nicolle Hospital

Tunis, Tunis Governorate, 1006, Tunisia

Location

Related Publications (8)

• Mancuso A, De Vivo A, Giacobbe A, Priola V, Maggio Savasta L, Guzzo M, De Vivo D, Mancuso A. General versus spinal anaesthesia for elective caesarean sections: effects on neonatal short-term outcome. A prospective randomised study. J Matern Fetal Neonatal Med. 2010 Oct;23(10):1114-8. doi: 10.3109/14767050903572158.

  PMID: 20088721 BACKGROUND

• Sklebar I, Bujas T, Habek D. SPINAL ANAESTHESIA-INDUCED HYPOTENSION IN OBSTETRICS: PREVENTION AND THERAPY. Acta Clin Croat. 2019 Jun;58(Suppl 1):90-95. doi: 10.20471/acc.2019.58.s1.13.

  PMID: 31741565 BACKGROUND

• Mercier FJ, Bonnet MP, De la Dorie A, Moufouki M, Banu F, Hanaf A, Edouard D, Roger-Christoph S. [Spinal anaesthesia for caesarean section: fluid loading, vasopressors and hypotension]. Ann Fr Anesth Reanim. 2007 Jul-Aug;26(7-8):688-93. doi: 10.1016/j.annfar.2007.05.003. Epub 2007 Jun 27. French.

  PMID: 17590565 BACKGROUND

• Ngan Kee WD, Khaw KS. Vasopressors in obstetrics: what should we be using? Curr Opin Anaesthesiol. 2006 Jun;19(3):238-43. doi: 10.1097/01.aco.0000192816.22989.ba.

  PMID: 16735804 BACKGROUND

• Heesen M, Stewart A, Fernando R. Vasopressors for the treatment of maternal hypotension following spinal anaesthesia for elective caesarean section: past, present and future. Anaesthesia. 2015 Mar;70(3):252-7. doi: 10.1111/anae.13007. Epub 2015 Jan 13. No abstract available.

  PMID: 25583307 BACKGROUND

• Mohta M, Dubey M, Malhotra RK, Tyagi A. Comparison of the potency of phenylephrine and norepinephrine bolus doses used to treat post-spinal hypotension during elective caesarean section. Int J Obstet Anesth. 2019 May;38:25-31. doi: 10.1016/j.ijoa.2018.12.002. Epub 2018 Dec 13.

  PMID: 30685301 BACKGROUND

• Ali Elnabtity AM, Selim MF. Norepinephrine versus Ephedrine to Maintain Arterial Blood Pressure during Spinal Anesthesia for Cesarean Delivery: A Prospective Double-blinded Trial. Anesth Essays Res. 2018 Jan-Mar;12(1):92-97. doi: 10.4103/aer.AER_204_17.

  PMID: 29628561 BACKGROUND

• Reynolds F, Seed PT. Anaesthesia for Caesarean section and neonatal acid-base status: a meta-analysis. Anaesthesia. 2005 Jul;60(7):636-53. doi: 10.1111/j.1365-2044.2005.04223.x.

  PMID: 15960713 RESULT

MeSH Terms

Conditions

Hypotension

Interventions

Norepinephrine; Ephedrine

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; Propanolamines; Propanols; Phenethylamines; Ethylamines

Study Officials

• Alia Jebri, MD

  Charles Nicolle Hospital Tunis

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: A total of 196 parturienst are randomly divided into two equal groups by an investigator not directly linked to the study. Groupe N : patients are received norepinephrine boluses (8 µg) ; prophylactic bolus immediately after spinal anesthesia induction and therapeutic boluses when systolic blood pressure falls to ≤ 20% of baseline. Groupe E : parturients are received ephedrine boluses (6 mg) ; systematic bolus after the induction of spinal anesthesia and therapeutic boluses if hypotention. The syringes will be labeled as syringe A and syringe B and the anesthesiologist who will give the bolus cannot know if it is ephedrine or norepinephrine.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of anesthesia and intensive care departement

Model Details: Groupe N : parturients are received norepinephrine boluses (8 µg) ; prophylactic bolus immediately after spinal anesthesia induction and therapeutic boluses when systolic blood pressure falls to ≤ 20% of baseline. Groupe E : parturients are received ephedrine boluses (6 mg) ; systematic bolus after the induction of spinal anesthesia and therapeutic boluses if hypotention.

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: July 12, 2024
• Study Start: August 1, 2024
• Primary Completion: January 10, 2025
• Study Completion: January 25, 2025
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)