Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension

Sponsor

General Hospital of Ningxia Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT04272567

Collaborator

(none)

Enrollment

Location

Arms

3.1

Actual Duration (Months)

32.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Adverse Effect	Drug: Norepinephrine Drug: Normal saline	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

99 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Prevention

Official Title:

Norepinephrine Prophylaxis for Postspinal Anesthesia Hypotension in Parturients Undergoing Cesarean Section: a Randomized, Placebo-controlled Dose-finding Trial

Actual Study Start Date :

Mar 28, 2020

Actual Primary Completion Date :

Jun 30, 2020

Actual Study Completion Date :

Jun 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Control group Simultaneous with subarachnoid block, a bolus of 1ml normal saline was given followed by normal saline infusion	Drug: Normal saline Simultaneous with subarachnoid block, a bolus of 1ml normal saline was given followed by normal saline infusion Other Names: NS
Experimental: 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).	Drug: Norepinephrine Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by different infusion dose of norepinephrine. Other Names: Vasopressors
Experimental: 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).	Drug: Norepinephrine Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by different infusion dose of norepinephrine. Other Names: Vasopressors
Experimental: 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).	Drug: Norepinephrine Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by different infusion dose of norepinephrine. Other Names: Vasopressors
Experimental: 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).	Drug: Norepinephrine Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by different infusion dose of norepinephrine. Other Names: Vasopressors

Outcome Measures

Primary Outcome Measures

The incidence of post-spinal anesthesia hypotension [1-15 minutes after spinal anesthesia.]
Systolic blood pressure (SBP) < 80% of the baseline

Secondary Outcome Measures

Overall stability of systolic blood pressure control versus baseline [1-15 minutes after spinal anesthesia.]
Evaluated by performance error (PE).
Overall stability of heart rate control versus baseline [1-15 minutes after spinal anesthesia.]
Evaluated by performance error (PE).
The incidence of severe post-spinal anesthesia hypotension. [1-15 minutes after spinal anesthesia.]
Systolic blood pressure (SBP) < 60% of the baseline.
The incidence of nausea and vomiting. [1-15 minutes after spinal anesthesia.]
Presence of nausea and vomiting in patients after spinal anesthesia
The incidence of bradycardia. [1-15 minutes after spinal anesthesia.]
Heart rate < 55 beats/min.
The incidence of hypertension. [1-15 minutes after spinal anesthesia.]
Systolic blood pressure (SBP) >120% of the baseline.
pH [Immediately after delivery.]
From umbilical arterial blood gases.
Partial pressure of oxygen [Immediately after delivery.]
From umbilical arterial blood gases.
Base excess [Immediately after delivery.]
From umbilical arterial blood gases.
APGAR score [1min after delivery]
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration
APGAR score [5min after delivery]
A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	General Hospital of Ningxia Medical University	Yinchuan	Ningxia	China	750004

Sponsors and Collaborators

General Hospital of Ningxia Medical University

Investigators

Study Chair: Xinli Ni, Dr., General Hospital of Ningxia Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

General Hospital of Ningxia Medical University

ClinicalTrials.gov Identifier:

NCT04272567

Other Study ID Numbers:

Yi Chen-2020-1

First Posted:

Feb 17, 2020

Last Update Posted:

Aug 4, 2020

Last Verified:

Feb 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by General Hospital of Ningxia Medical University

Additional relevant MeSH terms:

Hypotension

Norepinephrine

Study Results

No Results Posted as of Aug 4, 2020