Comparison of Phenylephrine and Norepinephrine for Spinal-induced Hypotension

• ClinicalTrials.gov Identifier: NCT04789005
• Recruitment Status: Completed
• First Posted: March 9, 2021
• Last Update Posted: March 9, 2021
• Sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.
• Information provided by (Responsible Party): ALLEN SUWAL, Tribhuvan University Teaching Hospital, Institute Of Medicine.

Study Description

Brief Summary:

Hypotension after spinal anaesthesia for cesarean deliveries is frequently encountered. Phenylephrine an α-agonist is commonly used for the prevention and treatment of spinal-induced hypotension. Phenylephrine causes baroreceptor-mediated bradycardia leading to subsequent reduction in cardiac output. Preservation of heart rate and cardiac output is important in high-risk conditions such as placental insufficiency, fetal distress and maternal cardiac disease. Recently, norepinephrine has been found as effective as phenylephrine in treatment of spinal induced hypotension. When norepinephrine is used as a bolus, it is effective at maintaining blood pressure while also conferring a greater heart rate and cardiac output compared to phenylephrine.

Condition or disease	Intervention/treatment	Phase
Spinal Induced-hypotension	Drug: Norepinephrine; Drug: Phenylephrine	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparison of Intravenous Phenylephrine and Norepinephrine for Treatment of Spinal-induced Hypotension in Caesarian Deliveries
• Actual Study Start Date: November 10, 2019
• Actual Primary Completion Date: May 5, 2020
• Actual Study Completion Date: May 5, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Phenylephrine group; Phenylephrine 100mcg was administered manually by the anaesthesiologist every time the SBP was 20% lower than baseline and the HR ≥60 bpm.	Drug: Phenylephrine; Phenylephrine 100mcg was administered manually by the anaesthesiologist every time the SBP was 20% lower than baseline and the HR ≥60 bpm.; Other Name: Phenylepherine group
Experimental: Norepinephrine group; Norepinephrine 8mcg was administered manually by the anaesthesiologist every time the SBP was 20% lower than baseline and the HR ≥60 bpm.	Drug: Norepinephrine; Norepinephrine 8mcg was administered manually by the anaesthesiologist every time the SBP was 20% lower than baseline and the HR ≥60 bpm.; Other Name: Norepinephrine group

Outcome Measures

Primary Outcome Measures :

1. To compare blood pressure between two groups. [ Time Frame: 6 months ]
2. To compare percentage of incidence of hypotension between two groups. [ Time Frame: 6 months ]
3. compare percentage of incidence of bradycardia between the two groups [ Time Frame: 6 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

Elective cesarean delivery under spinal anaesthesia ASA PS II Age ≥18 years Singleton pregnancy beyond 37 weeks' gestation Weight between 50 and 100 kg Height between 150 and 180 cm

Exclusion Criteria:

Patient refusal to participate Allergy or hypersensitivity to Norepinephrine or Phenylephrine Preexisting or pregnancy-induced hypertension Cardiovascular or cerebrovascular disease Fetal abnormalities Use of monoamine oxidase inhibitors or tricyclic antidepressants

Contacts and Locations

Locations

Nepal

Tribhuvan university teaching hospital

Kathmandu, Bagmati, Nepal, 00977

Sponsors and Collaborators

Tribhuvan University Teaching Hospital, Institute Of Medicine.

More Information

• Responsible Party: ALLEN SUWAL, Resident Anaesthesiology, Tribhuvan University Teaching Hospital, Institute Of Medicine.
• ClinicalTrials.gov Identifier: NCT04789005
• Other Study ID Numbers: 439/(6-11)E²/076/077
• First Posted: March 9, 2021
• Last Update Posted: March 9, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Hypotension; Vascular Diseases; Cardiovascular Diseases; Phenylephrine; Oxymetazoline; Norepinephrine; Cardiotonic Agents; Mydriatics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Sympathomimetics; Vasoconstrictor Agents; Nasal Decongestants; Respiratory System Agents; Adrenergic alpha-1 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Protective Agents