The Effect of Two Different Doses of Noradrenaline on Hypotension Caused by Spinal Anesthesia for Cesarean Section

• Sponsor: Assiut University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06102382
• Collaborator: (none)
• Enrollment: 100
• Arms: 2
• Anticipated Duration (Months): 12

Study Details

Study Description

Brief Summary

To compare two infusion rates of norepinephrine for prophylaxis against post-spinal hypotension during caesarean delivery.

Condition or Disease	Intervention/Treatment	Phase
Cesarean Section; Hypotension; Norepinephrine	Drug: Norepinephrine (0.1); Drug: Norepinephrine (0.075)	N/A

Detailed Description

Hypotension after spinal anesthesia for cesarean delivery is common and is caused mainly by peripheral vasodilatation. Although the intravenous administration of fluids helps, it does not always prevent maternal hypotension. Usually, this hypotension is treated with phenylephrine or ephedrine.

Norepinephrine has been recently introduced for prophylaxis against post-spinal hypotension during cesarean delivery due to its α-adrenergic activity in addition to the weak β-adrenergic activity.

Although the use of norepinephrine for this purpose has shown promising results. However, no sufficient data are available with regard to its optimum dose.

The objective of this study is to compare two infusion rates of norepinephrine for prophylaxis against post-spinal hypotension during caesarean delivery.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Effect of Two Different Doses of Noradrenaline on Hypotension Caused by Spinal Anesthesia for Cesarean Section
• Anticipated Study Start Date: Dec 10, 2023
• Anticipated Primary Completion Date: Dec 10, 2024
• Anticipated Study Completion Date: Dec 10, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Norepinephrine (0.1) An intravenous bolus dose of norepinephrine (5 µg) followed by infusion of 0.1 µg/kg/min till 5 minutes after delivery of the fetus.	Drug: Norepinephrine (0.1); An intravenous bolus dose of norepinephrine (5 µg) followed by infusion of 0.1 µg/kg/min till 5 minutes after delivery of the fetus.
Active Comparator: Norepinephrine (0.075) An intravenous bolus dose of norepinephrine (5 µg) followed by infusion of 0.075 µg/kg/min till 5 minutes after delivery of the fetus.	Drug: Norepinephrine (0.075); An intravenous bolus dose of norepinephrine (5 µg) followed by infusion of 0.075 µg/kg/min till 5 minutes after delivery of the fetus.

Outcome Measures

Primary Outcome Measures

1. The frequency of post-spinal hypotension [During the first hour after the subarachnoid block]

Secondary Outcome Measures

1. Arterial blood pressure (Systolic, diastolic, and mean) [During the first hour after the subarachnoid block]

2. Heart rate [During the first hour after the subarachnoid block]

3. Doses of atropine and ephedrine [Intraoperative]

4. Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score [1, 5, and 10 minutes after delivery]

   Ranges from 0 (the worst score) to 10 (the best score)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Pregnant women scheduled for cesarean section under spinal anesthesia

• Gestational age of at least 37 weeks

Exclusion Criteria:

• Patient refusal

• Contraindications of spinal anesthesia

• Allergy to the study drug

• Height<150 cm, weight < 60 kg, body mass index (BMI) ≥40 kg/m2.

• patients with cardiac morbidities

• Hypertensive disorders of pregnancy.

• Prepartum hemorrhage

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zakaria Ahmed Zakaria, Principal Investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT06102382
• Other Study ID Numbers: Noradrenaline in CS under SA
• First Posted: Oct 26, 2023
• Last Update Posted: Oct 30, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zakaria Ahmed Zakaria, Principal Investigator, Assiut University: Norepinephrine; Spinal anesthesia; Hypotension; Cesarean section
• Additional relevant MeSH terms: Hypotension; Norepinephrine

Study Results

No Results Posted as of Oct 30, 2023