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

NCT05892913 | Completed Phase 4

• 1 other identifier: BAIBU-Anesthesia-AA-03
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pregnancy; Cesarean Section; Anesthesia, Spinal; Atropine; Sympatholytic Effect; Spinal

Outcome Measures

Primary Outcomes (30)

• Heart rate

  Heart rate

  1. minunte after spinal block

• Heart rate

  Heart rate

  4. minute after spinal block

• Heart rate

  Heart rate

  7. minute after spinal block

• Heart rate

  Heart rate

  9. minute after spinal block

• Heart rate

  Heart rate

  12. minute after spinal block

• Heart rate

  Heart rate

  15. minute after spinal block

• Systolic Blood pressure

  Systolic Blood pressure

  1. minute after spinal block

• Systolic Blood pressure

  Systolic Blood pressure

  4. minute after spinal block

• Systolic Blood pressure

  Systolic Blood pressure

  7. minute after spinal block

• Systolic Blood pressure

  Systolic Blood pressure

  9. minute after spinal block

• Systolic Blood pressure

  Systolic Blood pressure

  12. minute after spinal block

• Systolic Blood pressure

  Systolic Blood pressure

  15. minute after spinal block

• Mean Blood Pressure

  Mean Blood Pressure

  1. minute after spinal block

• Mean Blood Pressure

  Mean Blood Pressure

  4. minute after spinal block

• Mean Blood Pressure

  Mean Blood Pressure

  7. minute after spinal block

• Mean Blood Pressure

  Mean Blood Pressure

  9. minute after spinal block

• Mean Blood Pressure

  Mean Blood Pressure

  12. minute after spinal block

• Mean Blood Pressure

  Mean Blood Pressure

  15. minute after spinal block

• Efedrine Consumption

  Efedrine Consumption in the first 15 minutes after the spinal block

  1. minute after spinal block

• Efedrine Consumption

  Efedrine Consumption in the first 15 minutes after the spinal block

  4. minute after spinal block

• Efedrine Consumption

  Efedrine Consumption in the first 15 minutes after the spinal block

  7. minute after spinal block

• Efedrine Consumption

  Efedrine Consumption in the first 15 minutes after the spinal block

  9. minute after spinal block

• Efedrine Consumption

  Efedrine Consumption in the first 15 minutes after the spinal block

  12. minute after spinal block

• Efedrine Consumption

  Efedrine Consumption in the first 15 minutes after the spinal block

  15. minute after spinal block

• Atropine Consumption

  Atropine Consumption in the first 15 minutes after the spinal block

  1. minute after spinal block

• Atropine Consumption

  Atropine Consumption in the first 15 minutes after the spinal block

  4. minute after spinal block

• Atropine Consumption

  Atropine Consumption in the first 15 minutes after the spinal block

  7. minute after spinal block

• Atropine Consumption

  Atropine Consumption in the first 15 minutes after the spinal block

  9. minute after spinal block

• Atropine Consumption

  Atropine Consumption in the first 15 minutes after the spinal block

  12. minute after spinal block

• Atropine Consumption

  Atropine Consumption in the first 15 minutes after the spinal block

  15. minute after spinal block

Study Arms (2)

Efedrine Group

ACTIVE COMPARATOR

For sympathetic blockade (SBP\<90) if developed in patients in the ephedrine group, a bolus dose of 5 mg/mL ephedrine would be used and repeated if necessary. In case of development of bradycardia (\<65/min) in this group, Atropine 0.5 mg/mL would be planned to be administered and repeated if necessary.

Drug: Ephedrine

Preemptive Atropine Group

EXPERIMENTAL

In the atropine group, 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). In this group if SBP\<90 despite slow dose atropine administration; it will be planed to give efedrine as bolus of 5 mg/mL. And for bradicardia (HR\<65/min) it will be planed to give Atropine 0.5 mg/mL.

Drug: Slow dose preemptive Atropine

Interventions

Slow dose preemptive Atropine DRUG

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)

Also known as: Atropine

Preemptive Atropine Group

Ephedrine DRUG

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.

Efedrine Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA Ι-ΙΙ Ages 18-40 Weight 55-105 kg Height 150-175 cm

You may not qualify if:

• Who does not require drug administration with fluid therapy Whose hemodynamic changes are within an acceptable range Diabetes COPD Hypertension BMI\>34 Preeclampsia/eclampsia Multiple pregnancies Pathology in the fetus Hematological problems such as Rh incompatibility Hypersensitivity to local anesthetics Contraindications to regional anesthesia

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Bolu Abant Izzet Baysal university Medical School, Anesthesiology and Reanimation D.

Bolu, 14230, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Atropine; Ephedrine

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Phenethylamines; Ethylamines

Study Officials

• Akcan Akkaya, MD.

  Bolu Abant Izzet Baysal university Medical School, Anesthesiology and Reanimation D.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr.

Study Record Dates

• First Submitted: May 27, 2023
• First Posted: June 7, 2023
• Study Start: July 19, 2023
• Primary Completion: October 10, 2023
• Study Completion: October 10, 2023
• Last Updated: October 11, 2023

Record last verified: 2023-10

Locations

TU (1)