Two Norepinephrine Rescue Bolus Doses for Management of Severe Post-spinal Hypotension During Elective Cesarean Delivery

NCT05290740 | Completed Phase 4

• 1 other identifier: MS-657-2021
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

Maternal hypotension after spinal block is a common complication after subarachnoid block in this population whose incidence reached 60% in many reports. Hypotension is associated with maternal and neonatal complications; therefore, it is highly recommended to use vasopressors, prophylactically and interactively, for prompt control maternal blood pressure. Despite the presence of various preventive regimens (fluid loading, maternal positioning, and vasopressors), many mothers develop intraoperative episodes of hypotension which requires the use of a vasopressor bolus. Norepinephrine (NE) is an alpha adrenergic agonist with weak beta adrenergic agonistic activity; and is increasingly used in obstetric anesthesia with acceptable maternal and neonatal outcomes. NE bolus could be used for rapid correction of maternal blood pressure in a dose which variedranged between 3.7-10 mcg. Till date, al the available data for the management of maternal hypotension did not differentiate between severe and non-severe hypotension. The incidence of severe maternal hypotension (systolic blood pressure ≤60% of baseline) ranged between 7-20%. In a recent report, Hassabelnaby et al compared 6 mcg and 10 mcg NE boluses in management of maternal hypotension and found that the doses had the same success rate (≈90%); however, most of the participants in the mentioned study had non-severe hypotension. Therefore, we hypothesize that severe hypotension should be separately investigated for the possible superiority of the higher over the lower dose of NE bolus. Insufficient NE bolus would lead to failed management and prolonged hypotensive episode, whereas a higher dose might lead to reactive hypertension and/or bradycardia, which is sometimes severe. Therefore, determining the optimum dose for NE bolus would enable proper control of maternal hemodynamic profile

Conditions

Postspinal Hypotension; Cesarean Delivery; Norepinephrine

Outcome Measures

Primary Outcomes (1)

• incidence of successful management of severe post-spinal hypotension

  systolic blood pressure \>80% of baseline within 2 min of drug injection

  2 minutes after drug injection

Secondary Outcomes (6)

• time to severe postspinal hypotension

  1 minute after subarachnoid local anesthetic injection till 1 min after baby delivery

• incidence of reactive bradycardia

  2 minutes after drug injection

• incidence of reactive hypertension

  2 minutes after drug injection

• incidence of nausea and vomiting

  1 minute after subarachnoid local anesthetic injection till 5 minute after baby delivery

• fetal umbilical blood pH

  at 5 minutes post delivery

Study Arms (2)

group A

ACTIVE COMPARATOR

Drug: Norepinephrine 5 mcg

group B

ACTIVE COMPARATOR

Drug: Norepinephrine 10 mcg

Interventions

Norepinephrine 5 mcg DRUG

norepinephrine bolus of 5 mcg for treatment of sever postspinal hypotension

group A

Norepinephrine 10 mcg DRUG

norepinephrine bolus of 10 mcg for treatment of sever postspinal hypotension

group B

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• full-term singleton pregnant women
• American society of anesthesiologist physical status of I or II,
• scheduled for elective cesarean delivery

You may not qualify if:

• Patients with uncontrolled cardiac morbidities (patients with tight valvular lesion, impaired contractility with ejection fraction \< 50%, heart block, and arrhythmias),
• hypertensive disorders of pregnancy,
• peripartum bleeding, coagulation disorders (patients with INR \>1.4 and or platelet count \< 80000 /dL) or
• any contraindication to regional anesthesia, and
• baseline systolic blood pressure (SBP) \< 100 mmHg

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Alaini Hospital

Cairo, 11562, Egypt

Location

Related Publications (1)

• Amin SM, Hasanin A, Ghanem NT, Mostafa M, Elzayat N, Elsherbiny M, Abdelwahab Y. Comparison of Two Norepinephrine Rescue Bolus Doses for Management of Severe Post-Spinal Hypotension During Elective Caesarean Delivery: A Randomized, Controlled Trial. Int J Gen Med. 2024 Jan 19;17:153-160. doi: 10.2147/IJGM.S446021. eCollection 2024.

  PMID: 38264276 DERIVED

MeSH Terms

Interventions

Norepinephrine

Intervention Hierarchy (Ancestors)

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

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: Principal Investigator

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 22, 2022
• Study Start: March 11, 2022
• Primary Completion: July 25, 2022
• Study Completion: July 25, 2022
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)