Effects Of Adjuvants to Caudal Anesthesia on Hemodynamics Measured By Electrical Cardiometry In Children

Study Overview
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Brief Summary
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Caudal epidural anesthesia is one of the most common regional techniques used for post-operative pain management in pediatric patients. In this study we are going to compare the effects of caudal bupivacaine , caudal Dexamethasone with bubivacaine and Dexmedetomidine with bupivacaine on the systemic vascular resistance and the cardiac output, in pediatric patients undergoing lower abdominal surgeries, by using the electrical cardiometry (EC).

Detailed Description
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Participants will be randomly allocated by a computer-generated table into one of the 3 study groups; the randomization sequence was concealed in sealed envelopes. The three study groups were as follows: Group A: Caudal Dexmedetomidine block group (DEXM) (n= 16) will receive caudal block using the bupivacaine 0.25% and Dexmedetomidine 1 μg/kg with the conventional general anesthesia, Group B: caudal Dexamethasone Block group (DEXA) (n =16) will receive caudal block using the bupivacaine 0.25% and Dexamethasone 0.1 mg/kg with the conventional general anesthesia, Group C: caudal with bubivacaine (CONTROL) group (n = 16) will receive caudal block using the bupivacaine 0.25% and general anesthesia. After induction of general anesthesia, the electrodes of the electrical cardiometry will be applied on the child neck and chest in the supine position and a measurement for the baseline cardiac output, systemic vascular resistance and stroke volume will be taken using the electrical cardiometry. Baseline blood pressure and heart rate will be also recorded.Then, another measurement for the systemic cardiac output, vascular resistance, stroke volume heart rate and blood pressure will be taken at 5minutes, 10 minutes, 20 minutes and 30 minutes after caudal block. The measurements will be stored and analyzed off-line. The Electrical Cardiometry device that will be used is the ICON™ monitor; (the Portable Noninvasive Hemodynamic Monitor manufactured by Osypka Medical Company). The measurements will be stored and analyzed off-line. The average values during three consecutive measures will be considered for the analysis.

Official Title
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Effects Of Adjuvants (Dexamethasone and Dexmedetomidine) to Caudal Anesthesia on Cardiac Output and Hemodynamics Measured By Electrical Cardiometry In Children: A Randomized Double Blind Study

Conditions
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Caudal Block

Intervention / Treatment
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* Drug: Caudal block with dexmedetomedine
* Drug: Caudal dexamethasone
* Drug: Control (bupivacaine)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric patients 1 - 7 years. Both genders (male & female). ASA I & ASA II patients. Children scheduled for lower abdominal elective surgeries including genitourinary and perineal regions surgeries. Exclusion Criteria: Parents' refusal of regional block. Patients requiring emergency procedures. Bleeding disorders. Skin lesions or wounds at site of proposed needle insertion. Cutaneous anomalies (angioma, hair tuft, nevus or a dimple) near the puncture point requiring radiological examination (ultrasound, CT or MRI). Progressive neurological disorders. Patients with congenital heart disease. Patients with Allergies to used drugs Surgeries with large fluid shift or massive blood loss.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Caudal block with dexmedetomedine<br>Caudal Dexmedetomidine block group (DEXM) (n= 16) will receive caudal block using the bupivacaine 0.25% and Dexmedetomidine 1 μg/kg with the conventional general anesthesia, | Drug: Caudal block with dexmedetomedine<br>* After induction, the electrical cardiometry is applied in supine position and a measurement for the baseline cardiac output, systemic vascular resistance and stroke volume is taken. In left lateral position, the back is sterilized. The block is done by introducing a 23-gauge needle perpendicular to the sacrococcygeal membrane. The needle is inserted until there is release of resistance as it pierces the sacro-coccygeal membrane. Then, it is directed upwards to make an angle of 20-30° with the skin about 2 mm. 1 ml/kg bupivacaine 0.25% along with dexmedetomidine 1 μg/kg (diluted with normal saline to 1ml) is injected over about 60s. Then, another measurement for the hemodynamics is taken at 5, 10, 20 and 30 minutes after caudal block.<br>* Other names: Precedex;|
| Active Comparator: Caudal block with dexamethasone<br>caudal Dexamethasone Block group (DEXA) (n =16) will receive caudal block using the bupivacaine 0.25% and Dexamethasone 0.1 mg/kg with the conventional general anesthesia, | Drug: Caudal dexamethasone<br>* After induction, the electrical cardiometry is applied in supine position and a measurement for the baseline cardiac output, systemic vascular resistance and stroke volume is taken. In left lateral position, the back is sterilized. The block is done by introducing a 23-gauge needle perpendicular to the sacrococcygeal membrane. The needle is inserted until there is release of resistance as it pierces the sacro-coccygeal membrane. Then, it is directed upwards to make an angle of 20-30° with the skin about 2 mm. 1 ml/kg bupivacaine 0.25% along with dexamethasone 0.1mg/kg (diluted with normal saline to 1ml) is injected over about 60s. Then, another measurement for the hemodynamics is taken at 5, 10, 20 and 30 minutes after caudal block.<br>* Other names: Decadrone;|
| Placebo Comparator: Control (caudal block with bupivacaine)<br>caudal with bubivacaine (CONTROL) group (n = 16) will receive caudal block using the bupivacaine 0.25% and general anesthesia. | Drug: Control (bupivacaine)<br>* After induction, the electrical cardiometry is applied in supine position and a measurement for the baseline cardiac output, systemic vascular resistance and stroke volume is taken. In left lateral position, the back is sterilized. The block is done by introducing a 23-gauge hypodermic needle perpendicular to the sacrococcygeal membrane. The needle is inserted until there is release of resistance as it pierces the sacro-coccygeal membrane. Then, it is directed upwards to make an angle of 20-30° with the skin about 2 mm. 1 ml/kg the control (bupivacaine) 0.25% is injected over about 60s. Then, another measurement for the hemodynamics is taken at 5, 10, 20 and 30 minutes after caudal block.<br>* Other names: Marcaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cardiac output | Cardiac output at 5 minutes, 10 minutes, 20 minutes and 30 minutes after caudal block,the cardiac output is measured with L/minute | up to 30 minutes |