Clinical trial NCT03101137: Effects Of Adjuvants to Caudal Anesthesia on Hemodynamics Measured By Electrical Cardiometry In Children
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Caudal Block
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 48
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Pediatric patients 1 - 7 years.
2. Both genders (male \& female).
3. ASA I \& ASA II patients.
4. Children scheduled for lower abdominal elective surgeries including genitourinary and perineal regions surgeries.

Exclusion Criteria:

1. Parents' refusal of regional block.
2. Patients requiring emergency procedures.
3. Bleeding disorders.
4. Skin lesions or wounds at site of proposed needle insertion.
5. Cutaneous anomalies (angioma, hair tuft, nevus or a dimple) near the puncture point requiring radiological examination (ultrasound, CT or MRI).
6. Progressive neurological disorders.
7. Patients with congenital heart disease.
8. Patients with Allergies to used drugs
9. Surgeries with large fluid shift or massive blood loss.

Primary outcomes:
measure: Change in Cardiac output
timeFrame: up to 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kasr El Aini Hospitals-Cairo university-Egypt
name: Nevine M Gouda, professor
role: STUDY_CHAIR
References:
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