Comparison Between Three Norepinephrine Bolus Doses for Management of Post-spinal Hypotension During Ceaserian Section for Patients With Preeclampsia

NCT ID: NCT05368415

Last Updated: 2022-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-15
• Study Completion Date: 2022-08-15

Brief Summary

Maternal hypotension after subarachnoid block is a frequent and deleterious complication during lower segment caesarean section (LSCS). Prophylaxis against hypotension using vasopressors had become a standard recommendation. In mothers with preeclampsia, post-spinal hypotension is less frequent compared to healthy mothers; thus, the latest guidelines do not recommend using vasopressors in preeclampsia patients unless there is a hypotensive episode . The incidence of post-spinal hypotension in mother with preeclampsia is nearly 25%. The commonly used vasopressors during CS are ephedrine, phenylephrine, and recently norepinephrine. The use of ephedrine is usually accompanied with maternal tachycardia and foetal acidosis. Phenylephrine (PE) had been the first line for prevention and management of maternal hypotension; however, its use in mothers with preeclampsia had not been adequately investigated. Thus, the best vasopressor for management of hypotension in mothers with preeclampsia is unknown. Norepinephrine (NE) is an alpha adrenergic agonist with weak beta adrenergic agonistic activity; thus, it does not cause significant cardiac depression as phenylephrine does. NE was introduced for use during CS with promising results when used as infusion and as boluses in healthy mothers .

The use of NE boluses in management of hypotension in preeclamptic mothers was not adequately investigated. A dose 4 mcg NE was recently evaluated in preeclamptic mothers. In this study, we will compare 3 NE bolus doses (3 mcg, 4 mcg, and 5 mcg) in management of maternal hypotension after spinal block during CS in preeclamptic mothers.

Conditions

Anesthesia; Adverse Effect; Cesarean Section Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

3 mcg grup

this group will receive Norepinephrine bolus of 3 mcg for management of hypotension.

Group Type: ACTIVE_COMPARATOR

Norepinephrine

Intervention Type: DRUG

mothers will received NE bolus of 3,4 or 5 mcg for management of hypotension according to group allocation

4 mcg group

this group will receive Norepinephrine bolus of 4 mcg for management of hypotension

Group Type: ACTIVE_COMPARATOR

Norepinephrine

Intervention Type: DRUG

mothers will received NE bolus of 3,4 or 5 mcg for management of hypotension according to group allocation

5 mcg group

this group will receive Norepinephrine bolus of 5 mcg for management of hypotension

Group Type: ACTIVE_COMPARATOR

Norepinephrine

Intervention Type: DRUG

mothers will received NE bolus of 3,4 or 5 mcg for management of hypotension according to group allocation

Interventions

Norepinephrine

mothers will received NE bolus of 3,4 or 5 mcg for management of hypotension according to group allocation

Intervention Type: DRUG

Other Intervention Names

levophed

Eligibility Criteria

Inclusion Criteria

• pregnant female with preeclampsia
• age 18-40

Exclusion Criteria

• age less than 18
• age above 40
• patient refusal of spinal anesthesia
• patient with eclampsia
• patient allergy to anesthesia drugs or to NE

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Sayed Arafa

lecturer of anesthesia and surgical ICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed S Arafa, MD

Role: PRINCIPAL_INVESTIGATOR

Lecturer of anesthesia and surgical ICU

Locations

Cairo university, Kasr Alainy hospital

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 32303180 (View on PubMed)

Hasanin A, Amin S, Refaat S, Habib S, Zayed M, Abdelwahab Y, Elsayad M, Mostafa M, Raafat H, Elshall A, Fatah SAE. Norepinephrine versus phenylephrine infusion for prophylaxis against post-spinal anaesthesia hypotension during elective caesarean delivery: A randomised controlled trial. Anaesth Crit Care Pain Med. 2019 Dec;38(6):601-607. doi: 10.1016/j.accpm.2019.03.005. Epub 2019 Mar 30.

Reference Type: BACKGROUND

PMID: 30935897 (View on PubMed)

Other Identifiers

Levo bolus in CS

Identifier Type: -

Identifier Source: org_study_id