Caudal Block Clinical Trial
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
Verified date | February 2018 |
Source | Kasr El Aini Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 48 |
Est. completion date | January 15, 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Year to 7 Years |
Eligibility |
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Kasr El Aini Hospital |
1) Shah N., Patel J., Chhaya A. and Upadhyaya R. Comparison of general anesthesia v/s caudal epidural in pediatric infra umbilical surgeries. International J of Biomed Res. 2015; 6(01): 35- 9.
10) Rajput RS, Das S., Chauhan S., Bisoi AK. & Vasdev S. Comparison of Cardiac Output Measurement by Noninvasive Method with Electrical Cardiometry and Invasive Method with Thermodilution Technique in Patients Undergoing Coronary Artery Bypass Grafting. Wor J Cardiovas S. 2014 ;(4): 123-130.
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.
14) Dalal S., Paul A. and Tirpude NG. Clinical Evaluation of Caudal Clonidine as an Adjuvant to Bupivacaine in Pediatric Patients Undergoing Sub Umbilical Surgeries. Research Chronicle in health sciences. 2015; 1(2): 110-121.
15) Alsadek W., Al-Gohari M., Elsonbaty M., Nassar N.& Alkonaiesy R. Ultrasound Guided TAP Block Versus Ultrasound Guided Caudal Block For Pain Relief In Children Undergoing Lower Abdominal Surgeries. Egyp J of Anaesth. 2015; (31): 155-160.
2) Almajali Z., Batarseh E., Daameh S., Qabha A. and Haddadin M. Comparison of Postoperative Pain Relief Impact between Caudal Bupivacaine Alone and Caudal Bupivacaine-Dexamethasone Mixture Administration for Pediatric Local Tube Urethroplasty. J of The R Med Serv. 2014; 21(4): 19-24.
3) Butterworth J., Mackey,D. & Wasnick,J. Morgan & Mikhail's Clinical Anesthesiology. 5th ed. the United States: McGraw-Hill Education, LLC. 2013; 877-905.
5) Bhaskar D. , Kumar P. , Mridul S. , Vipin D. , Vivek T. and Mohamed A. Comparison Of Caudal Dexmedetomidine And Fentanyl For Postoperative Analgesia. J of Adv Res in Bio Scien. 2014; 6 (1) 51-7.
6) El Gendy H.A. & Elsharnouby N.M. Ultrasound Guided Single Injection Caudal Epidural Anesthesia Of Isobaric Bupivacaine With/Without Dexamethasone For Geriatric Patients Undergoing Total Hip Replacement Surgery. Egyptian Journal of Anesthesia. 2014; 30: 293- 8.
Deng M, Wang X, Wang L, Zheng S. The hemodynamic effects of newborn caudal anesthesia assessed by transthoracic echocardiography: a randomized, double-blind, controlled study. Paediatr Anaesth. 2008 Nov;18(11):1075-81. doi: 10.1111/j.1460-9592.2008.02786.x. — View Citation
Farrag WS, Ibrahim AS, Mostafa MG, Kurkar A, Elderwy AA. Ketamine versus magnesium sulfate with caudal bupivacaine block in pediatric inguinoscrotal surgery: A prospective randomized observer-blinded study. Urol Ann. 2015 Jul-Sep;7(3):325-9. doi: 10.4103/0974-7796.152039. — View Citation
Galante D, Pellico G, Meola S, Caso A, De Capraris A, Milillo R, Mirabile C, Olivieri M, Cinnella G, Dambrosio M. Hemodynamic effects of levobupivacaine after pediatric caudal anesthesia evaluated by transesophageal doppler. Paediatr Anaesth. 2008 Nov;18(11):1066-74. doi: 10.1111/j.1460-9592.2008.02774.x. — View Citation
Larousse E, Asehnoune K, Dartayet B, Albaladejo P, Dubousset AM, Gauthier F, Benhamou D. The hemodynamic effects of pediatric caudal anesthesia assessed by esophageal Doppler. Anesth Analg. 2002 May;94(5):1165-8, table of contents. — View Citation
Mason KP, Lerman J. Review article: Dexmedetomidine in children: current knowledge and future applications. Anesth Analg. 2011 Nov;113(5):1129-42. doi: 10.1213/ANE.0b013e31822b8629. Epub 2011 Aug 4. Review. — View Citation
Xiang Q, Huang DY, Zhao YL, Wang GH, Liu YX, Zhong L, Luo T. Caudal dexmedetomidine combined with bupivacaine inhibit the response to hernial sac traction in children undergoing inguinal hernia repair. Br J Anaesth. 2013 Mar;110(3):420-4. doi: 10.1093/bja/aes385. Epub 2012 Nov 15. — View Citation
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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