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Comparison Between Different Anaesthesia Techniques Protecting Renal Function in Children Undergoing Radicle Nephrectomy

NCT05271253 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2022-03-09

No results posted yet for this study

Summary

Up to date, Renal Cell carcinomas (RCC) are one of the prevalent primary renal neoplasms affecting children \& surgical radical nephrectomy is the conventional standard of care, as the choice of non-surgical modalities like irradiation \& hormono-chemotherapy is still a subject of debate .

Worsening of postoperative renal function is not so far from these patients who underwent nephrectomy for RCC, thus peri-operative preservation of renal function is a great challenge facing anaesthologist aiming to abolishment of postoperative acute kidney injury (AKI) development. AKI is a serious clinical diverse which increases morbidity and mortality \& enhances the risk of development of chronic kidney disease (CKD). A major advances have shown that the associations between AKI and CKD after radical nephrectomy is as high as 65 %.

For years, the diagnosis of AKI was based on ordinary kidney function tests like serum creatinine \& blood urea nitrogen, which are not efficient nowadays, as they lack specificity for renal damage, besides they are affected by many other factors apart from kidney injury.

Cystatin C is an endogenous protein with low molecular weight (13 k Da), that is freely filtrated at the glomeruli and completely reabsorbed in the proximal renal tubules. It indicates renal injury indirectly through decreased GFR .

Serum neutrophil gelatinase-associated lipocalin (NGAL) is a promising glycoprotein produced by neutrophils and epithelial cells of the proximal convoluted tubule of the nephron cells. After renal stress or nephrotoxic damage its peak plasma level is reached within 6 hrs, then remains sustained for as long as 5 days.

Dexmedetomidine (Dex.) a newer, short acting, highly selective alph-2 agonist, that possess potent analgesic, amnestic, hypnotic \& sedative properties via actions on sleep-awake cycle in the brain. Several evidences reported its possible ability for renal protection.

Caudal epidural blockade is well known efficient technique that offer postoperative analgesia for multiple surgical procedures in children. Beside hemodynamic stability, they prevent progression of acute postoperative pain to chronic pain.

The investigators hypothesized that uses of Dex infusion in a programmed fashion in children undergoing RN, could produce optimum preservation of kidney function from the concurrent perioperative insult even in a very early phase of renal stress, relative to ordinary used protocols.

Conditions

  • Renal Injury
  • Child, Only

Interventions

DRUG

Dexmedetomidine

0.5 mic /kg dexmedetomedine is injected after induction of anaesthesia.

DRUG

bupivacaine

0.25% bupivacaine is injected in the caudal epidural space

DRUG

normal Saline

injection of normal Saline

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Principal Investigators

  • Hassan S ElHoshy, lecturer · Alexandria University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-10
Primary Completion
2021-11-29
Completion
2022-01-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05271253 on ClinicalTrials.gov