Different Noradrenaline Protocols in Post Spinal Hypotension in CS

NCT04701190 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2022-02-01

No results posted yet for this study

Summary

The incidence of hypotension after spinal anesthesia is approximately 60% in parturients undergoing cesarean section. As a consequence of hypotension, nausea-vomiting, dyspnea and neurological deterioration in patients and low Apgar scores in newborns may occur. Therefore, there is an increasing interest to prevent maternal post spinal hypotension by using several drugs including noradrenaline given in different protocols to the patients undergoing spinal anesthesia for cesarean section. However, there is no conclusive answer to the question of which dosage is the best to prevent the maternal post spinal hypotension in literature.

In this prospective randomized study, we aimed to compare different noradrenaline protocols for preventing maternal post spinal hypotension during elective cesarean delivery.

Conditions

Interventions

DRUG

Noradrenalin 10 microgram bolus

The noradrenaline bolus dosage of 10 microgram will be administered to the patient at the same time of obtaining cerebrospinal fluid running freely.

DRUG

Noradrenaline 5 microgram bolus

The noradrenaline bolus dosage of 5 microgram will be administered to the patient at the same time of obtaining cerebrospinal fluid running freely.

DRUG

Noradrenaline 0.1 microgram/kg/minute infusion

Infusion dosage: 0.1 microgram/kg/minute After the end of the injection of heavy marcaine 0.5% to the subarachnoid space, the infusion of noradrenaline with a 0.1 microgram/kg/minute dosage will be started. Noradrenaline will be continued until 5 minutes after delivery of fetus.

DRUG

Noradrenaline 0.05 microgram/kg/minute infusion

Infusion dosage: 0.05 microgram/kg/minute After the end of the injection of heavy marcaine 0.5% to the subarachnoid space, the infusion of noradrenaline with a 0.05 microgram/kg/minute dosage will be started. Noradrenaline will be continued until 5 minutes after delivery of fetus.

DRUG

Infusion dosage: 0.075 microgram/kg/minute infusion

nfusion dosage: 0.075 microgram/kg/minute After the end of the injection of heavy marcaine 0.5% to the subarachnoid space, the infusion of noradrenaline with a 0.075 microgram/kg/minute dosage will be started. Noradrenaline will be continued until 5 minutes after delivery of fetus.

PROCEDURE

Spinal anesthesia

Spinal anesthesia using 0.5% 10 milligram heavy bupivacaine plus 12.5 microgram fentanyl

Sponsors & Collaborators

  • Ankara University

    lead OTHER

Principal Investigators

  • Menekse Ozcelik, M.D · Associate Professor

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2021-12-15
Completion
2021-12-15

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04701190 on ClinicalTrials.gov