Impact of Pre-spinal Atropine on Post Spinal Hemodynamics and Cardiac Output Measured by Electrical Cardiometry in Caesarean Delivery

Anesthesia Clinical Trial

Official title:

Impact of Pre-spinal Atropine on Post Spinal Hemodynamics and Cardiac Output Measured by Electrical Cardiometry in Caesarean Delivery: Randomized Double Blinded Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05658380
• Other study ID #: R216/2022
• Status: Completed
• Phase: Phase 3
• Start date: December 25, 2022
• Est. completion date: May 25, 2023

Study information

• Verified date: July 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cesarean section is one of the most commonly performed surgical procedures; approximately 80-90% of elective cesarean sections are conducted using spinal anesthesia . Spinal anesthesia is the preferred technique for Cesarean Section (CS) due to its simplicity, reliability, low rates of airway complications, facilitation of postoperative analgesia, less neonatal exposure to potentially depressant drugs, to awake mother at the time of the birth of the child that establishes maternal-infant bonding and successful breastfeeding, and due to its low cost as compared to the general anesthesia . The chance of significant maternal hypotension is greater with spinal anesthesia than with epidural anesthesia. Left uterine displacement with appropriate administration of fluids and use of vasopressor medications can minimize the associated hypotension. Intravenous administration of crystalloid or colloid can reduce the degree of hypotension after spinal anesthesia for cesarean delivery.

Maternal hypotension is a frequent side effect of spinal anesthesia for cesarean delivery and it causes dangerous maternal and fetal effects . Maternal hypotension decreases uteroplacental circulation and it results in nausea, vomiting, bradycardia and different systems dysfunction particularly in the presence of other diseases as renal, hepatic, cardiac and neurological. Anesthesiologists should not allow hypotension to continue, this often requires the use of vasopressors to maintain blood pressure as ephedrine, phenylephrine and norepinephrine .

Cardiac output is the amount of blood pumped by the heart per unit of time and is determined by four factors: two factors that are intrinsic to the heart-heart rate and myocardial contractility-and two factors that are extrinsic to the heart -preload and afterload. Heart rate is defined as the number of beats per minute and is mainly influenced by the autonomic nervous system. Increases in heart rate escalate cardiac output if ventricular filling is adequate during diastole .

Atropine is an anticholinergic agent with its ability to treat bradycardia both in mother and fetus. Atropine is an anti-sialagogue as well as used to antagonize the muscarinic side effects of anticholinesterases. Atropine is detected in the umbilical circulation within 1 to 2 minutes of maternal administration, and an F/M ratio of 0.93 is attained at 5 minutes .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 25, 2023
• Est. primary completion date: May 25, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• American society of anaesthesiologists (ASA) II

• full term

• singleton

• pregnant women scheduled for elective Cs

Exclusion Criteria:

• patients refusal

• with body mass index (BMI) > 35 Kg/m2

• polyhydramnios

• history of impaired cardiac contractility

• valvular heart disease

• cardiac arrhythmias

• hypertensive pregnancy disorders

• thyrotoxicosis

• cerebrovascular diseases

• foetal abnormalities

• Contraindications to spinal anesthesia as coagulopathy, infection at the site of needle insertion

• uncorrected hypovolemic shock

• increased intracranial pressure from mass effect

• inadequate resources or expertise.

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• atropine
patients will receive 0.01 mg/kg intravenous atropine in 5 ml normal saline 0.9 % before induction of spinal anaesthesia
• Isotonic saline
patients will receive the same volume of isotonic saline 0.9% 5ml (control group) before induction of spinal anaesthesia

Locations

Country	Name	City	State
Egypt	Ain Shams University hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in cardiac output measurment	change in cardiac output (CO) will be measured by electrical cardiometry	basline and 5 minute after spinal anesthesia