Comparing the Hemodynamic Effects of Epinephrine Versus Dexmedetomidine as an Adjuvant to Bupivacaine in Caudal Anaesthesia Assessed by Cardiometry

Sponsor

Kasr El Aini Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05860010

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

19.5

Patients Per Site

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Electrical cardiometry (EC) is a non-invasive method of estimating cardiac parameters by measuring changes in thoracic bioimpedance during the cardiac cycle. The ICON (Cardiotronic Osypka Medical, San Diego, California) monitor uses four electrocardiogram electrodes and estimates the maximum rate of impedance change to peak aortic blood acceleration. An impedance change occurs between diastole and systole as red blood cell orientation is altered from random during diastole to align during systole. This device is validated against Fick cardiac output and transthoracic echocardiography in infants and children, as well as thermodilution in adults with R values of 0.9. This device is approved by the Food and Drug Administration (FDA) for use in pediatrics. Hypotension is expected to occur after epidural anesthesia (EA) due to the dilatation of venous vessels by sympathetic blockade with a subsequent decrease in venous return and cardiac output (CO). Also, the association of general anesthesia (GA) to EA can lead to more decrease in CO. The addition of epinephrine to local anesthetics (LA) could worsen hypotension through the systemic absorption of epinephrine that leads to a vasodilator β effect. Yet, CO may be enhanced by this β-adrenergic stimulation. However, it is well known that caudal epidural anesthesia has few or no hemodynamic changes in children less than 8 yr old. This could be attributed to the immaturity of their sympathetic system and smaller lower-limbs blood volume compared to adults. Caudal anesthesia is highly effective in abdominal, urinary tract, and lower extremity surgeries in children for intra- and postoperative analgesia. The addition of dexmedetomidine to local anesthetics in caudal anesthesia is a frequent practice. Dexmedetomidine, a highly selective alpha-2 adrenoreceptor agonist, is used as an intravenous sedative and analgesic drug. It has an a2/a1 selectivity ratio of 1600: 1 and is eight times more potent than clonidine. Intrathecal and epidural dexmedetomidine have been reported to produce analgesic properties, prolonging the duration of local anesthetics without causing nerve damage in pediatric patients.

Although basal heart rate is greater than in adults, activation of the parasympathetic nervous system, anesthetic overdose, or hypoxia can quickly trigger bradycardia and profound reductions in cardiac output. The sympathetic nervous system and baroreceptor reflexes are not fully mature and the infant cardiovascular system displays a blunted response to exogenous catecholamines. That's why it is very essential to determine the hemodynamic effects of any drug used as an adjuvant to local anesthetics for caudal block and to explore whether it reduces the child cardiac output or not.

As invasive cardiac monitors are rarely indicated in pediatric patients, and little is known about the impact of caudally administered dexmedetomidine on cardiac function, so we aimed to investigate its effect on hemodynamic functions measured by EC.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia, Local	Drug: Epinephrine injection Drug: Dexmedetomidine Drug: Bupivacaine	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

39 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

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

Primary Purpose:

Basic Science

Official Title:

Comparing the Hemodynamic Effects of Epinephrine Versus Dexmedetomidine as an Adjuvant to Bupivacaine in Caudal Anaesthesia Assessed by Cardiometry: a Randomized, Double-blind, Controlled Study

Anticipated Study Start Date :

Jun 5, 2023

Anticipated Primary Completion Date :

Nov 5, 2023

Anticipated Study Completion Date :

Dec 5, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: control Bupivacaine will be administered in the caudal space	Drug: Bupivacaine patients will be placed on left lateral position and drug will be given the caudal space
Active Comparator: dexmedetomidine caudal with dexmedetomidine	Drug: Dexmedetomidine patients will be placed on left lateral position and drug will be given the caudal space Drug: Bupivacaine patients will be placed on left lateral position and drug will be given the caudal space
Active Comparator: epinephrine caudal with epinephrine	Drug: Epinephrine injection patients will be placed on left lateral position and drug will be given the caudal space Drug: Bupivacaine patients will be placed on left lateral position and drug will be given the caudal space

Arm

Intervention/Treatment

Placebo Comparator: control

Bupivacaine will be administered in the caudal space

Drug: Bupivacaine