Vasopressor Infusion in Cesarean Delivery

NCT ID: NCT03248791

Last Updated: 2021-09-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-20
• Study Completion Date: 2022-03-10

Brief Summary

Comparison will be conducted between continuous variable infusions of both drugs (Phenylephrine and Norepinephrine) with starting doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min respectively 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, we will compare continuous variable infusion of both drugs (PE and NE) with doses of 0.75 mcg/Kg/min and 0.1 mcg/Kg/min respectively for prophylaxis against PSH during CD.

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

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 infusion by a starting rate of 0.1 mcg/Kg/min. The rate will be then adjusted according to the patient blood pressure

Group Type: EXPERIMENTAL

Norepinephrine

Intervention Type: DRUG

Norepinephrine variable infusion with a starting rate of 0.1 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 variable infusion with a starting rate of 0.1 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

noradrenaline; Marcaine

Eligibility Criteria

Inclusion Criteria

• full term
• pregnant women
• scheduled for cesarean section

Exclusion Criteria

• pre-ecpamsia
• eclampsia
• bleeding
• cardiac dysfuction

• 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 Mukhtar, Professor

Role: STUDY_DIRECTOR

Head of research committee section in anesthesia department

Locations

Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ahmed Hasanin, Professor

Role: CONTACT

ahmedmohamedhasanin@gmail.com

+201095076954

Facility Contacts

ahmed Shash, Professor

Role: primary

+201001033999

Other Identifiers

N-86-2017

Identifier Type: -

Identifier Source: org_study_id