Norepinephrine Versus Phenylephrine Continuous Variable Infusion in Cesarean Delivery

NCT ID: NCT03328533

Last Updated: 2018-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-10
• Study Completion Date: 2018-05-05

Brief Summary

Comparison will be conducted between continuous variable infusions of Phenylephrine with starting dose of 0.75 mcg/Kg/min and Norepinephrine Bitartrate with starting dose of 0.1 mcg/Kg/min (with norepinephrine base of 0.05 mcg/Kg/min) for prophylaxis against Post-spinal hypotension during cesarean delivery

Detailed Description

Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery (CD). Many vasopressors have been used for prevention of post-spinal hypotension (PSH) during CD; however, the optimum protocol for prophylaxis is not established yet. Phenylephrine (PE) is a popular vasopressor used in obstetric anesthesia; however, its use is limited by its marked cardiac depressant nature. Norepinephrine (NE) is a potent vasopressor characterized by both α adrenergic agonistic activity in addition to a weak β adrenergic agonistic activity; thus, NE is considered a vasopressor with minimal cardiac depressant effect; these pharmacological properties would make NE an attractive alternative to PE. In this study, the investigators will compare continuous variable infusion of both drugs (PE and NE) with doses of 0.75 mcg/Kg/min and 0.05 mcg/Kg/min respectively for prophylaxis against PSH during CD. We used Norepinephrine Bitartrate 8 mg ampules which contains norepinephrine base of 4 mg.

Conditions

Cesarean Section Complications; Spinal Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Phenylephrine

Will receive spinal anesthesia using Bupivacaine. Then, phenylephrine infusion by a starting rate of 0.75 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure. The infusion will stop in case of reactive hypertension. The infusion will start again when blood pressure returns to normal reading. Infusion will be increased by 20% if hypotension occurred.

Group Type: ACTIVE_COMPARATOR

Phenylephrine

Intervention Type: DRUG

Phenylephrine variable infusion with a starting rate of 0.75 mcg/Kg/min.

Bupivacaine

Intervention Type: DRUG

Bupivacaine will be injected in the subarachnoid space with a dose of 10 mg.

Norepinephrine

Will receive spinal anesthesia using Bupivacaine. Then, norepinephrine bitartrate infusion by a starting rate of 0.1 mcg/Kg/min (equivalent to norepinephrine base of 0.05 mcg/Kg/min). The rate will be then adjusted according to the patient blood pressure. The infusion will stop in case of reactive hypertension. The infusion will start again when blood pressure returns to normal reading. Infusion will be increased by 20% if hypotension occurred.

Group Type: EXPERIMENTAL

Norepinephrine

Intervention Type: DRUG

Norepinephrine bitartrate variable infusion with a starting rate of 0.1 mcg/Kg/min (equivalent to norepinephrine base of 0.05 mcg/Kg/min).

Bupivacaine

Intervention Type: DRUG

Bupivacaine will be injected in the subarachnoid space with a dose of 10 mg.

Interventions

Phenylephrine

Phenylephrine variable infusion with a starting rate of 0.75 mcg/Kg/min.

Intervention Type: DRUG

Norepinephrine

Norepinephrine bitartrate variable infusion with a starting rate of 0.1 mcg/Kg/min (equivalent to norepinephrine base of 0.05 mcg/Kg/min).

Intervention Type: DRUG

Bupivacaine

Bupivacaine will be injected in the subarachnoid space with a dose of 10 mg.

Intervention Type: DRUG

Other Intervention Names

Levophed; Marcaine

Eligibility Criteria

Inclusion Criteria

• Full term
• Pregnant women
• Scheduled for cesarean section

Exclusion Criteria

• Pre-eclampsia
• Eclampsia
• Bleeding
• Cardiac dysfunction

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

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Hasanin

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed M Mukhtar, Professor

Role: STUDY_DIRECTOR

Head of research committee section in anesthesia department

Locations

Cairo University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

N-82-2017

Identifier Type: -

Identifier Source: org_study_id