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

NCT ID: NCT03101137

Last Updated: 2018-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-01-15

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.

Conditions

Caudal Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Caudal block with dexmedetomedine

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 Type: ACTIVE_COMPARATOR

Caudal block with dexmedetomedine

Intervention Type: DRUG

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.

Caudal block with dexamethasone

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 Type: ACTIVE_COMPARATOR

Caudal dexamethasone

Intervention Type: DRUG

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.

Control (caudal block with bupivacaine)

caudal with bubivacaine (CONTROL) group (n = 16) will receive caudal block using the bupivacaine 0.25% and general anesthesia.

Group Type: PLACEBO_COMPARATOR

Control (bupivacaine)

Intervention Type: DRUG

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.

Interventions

Caudal block with dexmedetomedine

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.

Intervention Type: DRUG

Caudal dexamethasone

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.

Intervention Type: DRUG

Control (bupivacaine)

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.

Intervention Type: DRUG

Other Intervention Names

Precedex; Decadrone; Marcaine

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Doaa Fawzy Abd El Fattah Hassan

Assistant lecturer of anesthesia, surgical ICU and pain management - Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nevine M Gouda, professor

Role: STUDY_CHAIR

Kasr El Aini Hospitals-Cairo university-Egypt

References

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Reference Type: BACKGROUND

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13) Almajali Z., Batarseh E., Daameh S., Qabha A., Haddadin M. Comparison Of Postoperative Pain Relief Impact Between Caudal Bupivacaine Alone And Caudal Bupivacaine-Dexamethasone Mixture Administration For Pediatric Local Tube Urethroplasty. J Roy Med Serv. 2014; 21(4): 19-24.

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Other Identifiers

N6-2016/MD

Identifier Type: -

Identifier Source: org_study_id