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The Effect of Low-dose Atropine on Sympathetic Blockade in Spinal Cesarean Section Patients

NCT05892913 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-10-11

No results posted yet for this study

Summary

The most common side effect in cesarean section surgeries performed under spinal anesthesia is hypotension, which is seen in over 80% and can cause significant morbidity for the mother and fetus. This side effect results from the sympathetic blocking effect, which also causes bradycardia.

A combined approach is supported in the prevention and treatment of hypotension, which recommends adequate fluid support, low-dose spinal anesthesia, and appropriate vasopressor (such as ephedrine, and phenylephrine) and, if bradycardia develops, the use of atropine as a parasympatholytic agent.

In this study, the investigators planned to investigate the possible benefits of preemptive administration of atropine, the dose of which is calculated in proportion to the patient's weight, as soon as a 10% decrease in heart rate is detected, in order to balance the sympathetic blockade due to spinal anesthesia in cesarean section operations.

Conditions

  • Pregnancy
  • Cesarean Section
  • Anesthesia, Spinal

Interventions

DRUG

Slow dose preemptive Atropine

it will planned to administer 0.4 mg/4mL diluted atropine in 20 seconds(10mcg/kg), as a slow bolus as bradycardia would expected (10% reduction in peak heart rate after spinal anesthesia)

DRUG

Ephedrine

For sympathetic blockade (SBP\<90) developed in patients in the ephedrine group, a bolus dose of 5 mg/mL ephedrine was used and repeated if necessary.

Sponsors & Collaborators

  • Abant Izzet Baysal University

    lead OTHER

Principal Investigators

  • Akcan Akkaya, MD. · Bolu Abant Izzet Baysal university Medical School, Anesthesiology and Reanimation D.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-07-19
Primary Completion
2023-10-10
Completion
2023-10-10

Countries

  • Turkey (Türkiye)

Study Locations

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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 NCT05892913 on ClinicalTrials.gov