Prophylactic Norepinephrine and Phenylephrine Boluses for Postspinal Anesthesia Hypotension

NCT ID: NCT05035888

Last Updated: 2023-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-05
• Study Completion Date: 2023-01-03

Brief Summary

The purpose of this study is to investigate the potency between prophylactic norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension in patients undergoing caesarean section.

Detailed Description

Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. Vasopressor has been highly recommended for routine prevention and/or treatment of post-spinal anesthesia hypotension. As a potential substitute drug for phenylephrine, norepinephrine has gradually been used in parturients undergoing cesarean section. There's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. However, few studies had been indicated the ED50 (prevent postspinal hypotension in 50% of patients) and ED90 of prophylactic norepinephrine bolus and its potency compared to phenylephrine for postspinal anesthesia hypotension in patients undergoing caesarean section. The purpose of this study is to investigate the potency between prophylactic norepinephrine and phenylephrine boluses for postspinal anesthesia hypotension in patients undergoing caesarean section.

Conditions

Adverse Effect

Study Design

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

Study Groups

Phenylephrine group

Prophylactic phenylephrine bolus simultaneous with spinal anesthesia

Group Type: ACTIVE_COMPARATOR

Phenylephrine

Intervention Type: DRUG

An initial prophylactic bolus dose of phenylephrine (37.5μg) simultaneous with spinal anesthesia. If the patient did not respond adequately to the current dose (SBP decreased to \< 80% of baseline), the dose was considered to have failed and the subsequent dose for the following patient was increased to the next higher dose level. The dose administered to subsequent patients varied by increments or decrements of 12.5 μg according to the responses of previous patients according to the up-down sequential allocation.

Norepinephrine group

Prophylactic norepinephrine bolus simultaneous with spinal anesthesia

Group Type: EXPERIMENTAL

Norepinephrine

Intervention Type: DRUG

An initial prophylactic bolus dose of norepinephrine (3μg) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 1 μg according to the responses of previous patients according to the up-down sequential allocation.

Interventions

Phenylephrine

An initial prophylactic bolus dose of phenylephrine (37.5μg) simultaneous with spinal anesthesia. If the patient did not respond adequately to the current dose (SBP decreased to \< 80% of baseline), the dose was considered to have failed and the subsequent dose for the following patient was increased to the next higher dose level. The dose administered to subsequent patients varied by increments or decrements of 12.5 μg according to the responses of previous patients according to the up-down sequential allocation.

Intervention Type: DRUG

Norepinephrine

An initial prophylactic bolus dose of norepinephrine (3μg) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 1 μg according to the responses of previous patients according to the up-down sequential allocation.

Intervention Type: DRUG

Other Intervention Names

Vasopressors; Vasopressors

Eligibility Criteria

Inclusion Criteria

• 18-45 years
• Primipara or multipara
• Singleton pregnancy ≥37 weeks
• American Society of Anesthesiologists physical status classification I to II
• Scheduled for cesarean section under spinal anesthesia

Exclusion Criteria

• Body height < 150 cm
• Body weight > 100 kg or body mass index (BMI) ≥ 40 kg/m2
• Eclampsia or chronic hypertension or baseline blood pressure ≥180 mmHg
• Hemoglobin < 7g/dl
• Fetal distress, or known fetal developmental anomaly

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

General Hospital of Ningxia Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yi Chen, M.D.

Role: STUDY_CHAIR

General Hospital of Ningxia Medical University

Locations

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Countries

China

Other Identifiers

Yi Chen-2021-6

Identifier Type: -

Identifier Source: org_study_id