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

Sponsor

Ain Shams University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05658380

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

20.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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 .

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Drug: atropine Drug: Isotonic saline	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 25, 2022

Anticipated Primary Completion Date :

Mar 25, 2023

Anticipated Study Completion Date :

Mar 25, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: atropine

Drug: atropine

patients will receive 0.01 mg/kg intravenous atropine in 5 ml normal saline 0.9 % before induction of spinal anaesthesia

Placebo Comparator: normal saline

Drug: Isotonic saline

patients will receive the same volume of isotonic saline 0.9% 5ml (control group) before induction of spinal anaesthesia

Outcome Measures

Primary Outcome Measures

change in cardiac output measurment [basline and 5 minute after spinal anesthesia]
change in cardiac output (CO) will be measured by electrical cardiometry

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University hospitals	Cairo		Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amin Mohammed Alansary Amin Ahmed Helwa, Assistant professor, Ain Shams University

ClinicalTrials.gov Identifier:

NCT05658380

Other Study ID Numbers:

R216/2022

First Posted:

Dec 20, 2022

Last Update Posted:

Dec 28, 2022

Last Verified:

Dec 1, 2022

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

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

Additional relevant MeSH terms:

Atropine

Study Results

No Results Posted as of Dec 28, 2022