Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension

NCT ID: NCT04272567

Last Updated: 2020-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-28
• Study Completion Date: 2020-06-30

Brief Summary

The purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against post-spinal anesthesia hypotension.

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. Vasopressors 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. But the ideal infusion dose of norepinephrine is still unknown. The purpose of this study is to investigate the suitable infusion dose of norepinephrine for prophylaxis against post-spinal anesthesia hypotension.

Conditions

Adverse Effect

Study Design

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

Study Groups

Control group

Simultaneous with subarachnoid block, a bolus of 1ml normal saline was given followed by normal saline infusion

Group Type: SHAM_COMPARATOR

Normal saline

Intervention Type: DRUG

Simultaneous with subarachnoid block, a bolus of 1ml normal saline was given followed by normal saline infusion

0.025 μg/kg/min group

Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.025 μg/kg/min).

Group Type: EXPERIMENTAL

Norepinephrine

Intervention Type: DRUG

Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by different infusion dose of norepinephrine.

0.05 μg/kg/min group

Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.05 μg/kg/min).

Group Type: EXPERIMENTAL

Norepinephrine

Intervention Type: DRUG

Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by different infusion dose of norepinephrine.

0.075 μg/kg/min group

Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.075 μg/kg/min).

Group Type: EXPERIMENTAL

Norepinephrine

Intervention Type: DRUG

Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by different infusion dose of norepinephrine.

0.1 μg/kg/min group

Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by a maintenance dose of norepinephrine (0.1 μg/kg/min).

Group Type: EXPERIMENTAL

Norepinephrine

Intervention Type: DRUG

Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by different infusion dose of norepinephrine.

Interventions

Norepinephrine

Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by different infusion dose of norepinephrine.

Intervention Type: DRUG

Normal saline

Simultaneous with subarachnoid block, a bolus of 1ml normal saline was given followed by normal saline infusion

Intervention Type: DRUG

Other Intervention Names

Vasopressors; NS

Eligibility Criteria

Inclusion Criteria

• 18-40 years
• Primipara or multipara
• Singleton pregnancy ≥37 weeks
• American Society of Anesthesiologists physical status classification I to II
• Scheduled for elective 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 ≥ 160mmHg
• Hemoglobin < 7g/dl
• Fetal distress, or known fetal developmental anomaly

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 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

Xinli Ni, Dr.

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-2020-1

Identifier Type: -

Identifier Source: org_study_id