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

NCT05271253 | Completed Phase 2 DMC

• 1 other identifier: 0305085
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

radical nephrectomy

Outcome Measures

Primary Outcomes (4)

• cystatin C

  Early biomarkers in detection of renal impairment

  immediately after induction

• cystatin C

  Early biomarkers in detection of renal impairment

  after 12 hours post-operatively

• NGAL

  Early biomarkers in detection of renal impairment

  immediately after induction

• NGAL

  Early biomarkers in detection of renal impairment

  after 12 hours post-operatively

Secondary Outcomes (6)

• serum creatinine

  immediately after induction

• serum creatinine

  after 12 hours post-operatively

• creatinine clearance

  immediately after induction

• creatinine clearance

  after 12 hours post-operatively

• sedation score

  5 mins post-operative

Study Arms (3)

Group (C)

ACTIVE COMPARATOR

caudal group, where caudal anaesthesia was given using 1 mL/kg dose of 0.25% bupivacaine without epinephrine.

Drug: bupivacaine

Group (D)

ACTIVE COMPARATOR

Dexmedetomidine (D) group, where Dex. (Precedex, hospira, Egypt) 0.8 μg/kg was given intravenously over 10 min as a loading dose, and then infused at a rate of 0.4 μg/kg/h

Drug: Dexmedetomidine

Group (P)

PLACEBO COMPARATOR

Placebo (P) group, where normal saline instead of Dex was given in volume (ml) and rate (ml/h) calculated related to the patient's body weight.

Drug: normal Saline

Interventions

Dexmedetomidine DRUG

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

Also known as: preceedex

Group (D)

bupivacaine DRUG

0.25% bupivacaine is injected in the caudal epidural space

Group (C)

normal Saline DRUG

injection of normal Saline

Also known as: 0.9 % Nacl

Group (P)

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• patients aged 5-10 years undergoing elective RN

You may not qualify if:

• had history of use of α 2-agonists to treat hypertension, renal impairment (creatinine clearance \< 90 ml/min), and persistent intraoperative hypotension \[mean arterial blood pressure \< 65 for \> 20 min\]. Also those with bleeding disorders and skin lesion at puncture site.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Haasan Elhoshy

Alexandria, 21615, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Bupivacaine; Saline Solution; Sodium Chloride

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Hassan S ElHoshy, lecturer

  Alexandria University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients were randomly allocated into 3 equal groups (25 patients each): Group (C): caudal group, where caudal anaesthesia was given using 1 mL/kg dose of 0.25% bupivacaine without epinephrine. Dexmedetomidine (D) group, where Dex. (Precedex, hospira, Egypt) 0.8 μg/kg was given intravenously over 10 min as a loading dose, and then infused at a rate of 0.4 μg/kg/h; and Placebo (P) group, where normal saline instead of Dex was given in volume (ml) and rate (ml/h) calculated related to the patient's body weight.

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: March 9, 2022
• Study Start: April 10, 2021
• Primary Completion: November 29, 2021
• Study Completion: January 15, 2022
• Last Updated: March 9, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)