CClinicalTrials.gg
CompletedNCT05271253Updated Mar 9, 2022

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

A Phase 2/3 interventional study of Dexmedetomidine and bupivacaine in Renal Injury and Child, Only, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to participants aged 5 Years to 10 Years. Per ClinicalTrials.gov, last updated 2022-03-09.

Sponsored by Alexandria University · Phase 2/3, Interventional, and Prevention

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Apr 2021, registered Jan 2022).
Phase
Phase 2/3
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
5 Years to 10 Years
Sex
All
01

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.

Read the detailed description

Aim of the study The primary goal was comparison between different anaesthesia techniques in preservation of kidney function using early phase detectors cystatin C and NGAL. Secondary goals included measurements of creatinine clearance, serum creatinine, and urinary output. Postoperative pain assessment using visual analogue scale \& sedation score were also recorded.

  1. Patients and methods

After approval of the Ethical committee of faculty of Medicine, Alexandria University and obtaining an informed written consent from parents of the children included in the study, 75 patients aged 5-10 years undergoing elective RN were randomly enrolled using closed envelope method. Sample Size was calculated according to the following equation:

n=(t\^2×p(1-p))/m\^3

The patients were excluded if they 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.

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. The infusions were prepared by independent participant \& were started after induction of anaesthesia and continued 24 hrs postoperatively. All children were assessed thoroughly preoperatively by history taking, physical examination \& laboratory investigations (complete blood count, coagulation profile liver function \& kidney functions.) At the night before surgery, base line value of serum creatinine, creatinine clearance were obtained using standard laboratory methods. Also, base line value of serum cystatin C and NGAL were obtained using commercially available kits (Roche Diagnostics, Mannheim, Germany) \& (Biosite Incorporated, San Diego, CA, USA) respectively by ELISA method. Establishment of method and degree of sample dilution were carried out prior to analysis according to manufacture instruction.

All children were premedicated orally with midazolam 0.5 mg/ k.g 30 minutes before induction, and they were instructed to void just before admission to the operating room.

In the operating theater, all patients were monitored throughout surgery by continuous electrocardiography, heart rate, pulse oximetry, non invasive blood pressure and end tidal capnography by (Datex-Omeda model S/5) monitor. Induction was carried out with fentanyl (1-1.5 μg/kg), and propofol (1-2 mg/kg). For facilitating endotracheal intubation, atracurium was administered at an initial dose of 0.5 mg/kg followed by boluses of 0.03 mg/kg every 20-40 min. Under aseptic technique, an arterial line and central venous catheter were inserted \& Anaesthesia was maintained using isoflurane 1-2% in oxygen, and patients were mechanically ventilated. Fentanyl and atracurium increments were given as required.

The diagnostic criteria of AKI was classified according to the Acute Kidney Injury Network (AKIN) criteria as follows: the renal function decreased rapidly within 48 hours, the s Cr level increased by ≥ 26.5 µ mol/L or ≥ 1.5 times from baseline, or urine output \< 0.5 mL/kg/h for > 6 hours. Oliguria is defined as urine output \< 0.5 ml/kg/h. After exclusion of catheter obstruction, patients were managed with good hydration. If it persists, 10 mg I.v Lasix was given, that could be repeated twice. If no response, nephrology consultation was ordered. At the end of surgery, muscle relaxants were reversed by neostigmine 0.04-0.06 mg/kg and atropine 0.02 mg/kg, and then the patients were extubated after returning to full muscle power. All patients were monitored in the intensive care unit for 2 days after surgery, with attention to fluid balance and urine output. Serum creatinine, creatinine clearance, Cystatin C and NGAL was assessed 24 hr before surgery, after induction of anaesthesia, 12 and 24 hrs postoperatively. Urine output was assessed intraoperatively every 1 hr and postoperatively every 6 hr in the first 24 hrs. Sedation was assessed during the first 5, 15, 30, and 60 mins in the recovery room by the investigator using a five-point sedation scale. Sedation level: Agitated = 4, Awake= 3, Drowsy= 2, Asleep= 1. A sedation score of 3 \& above was considered as unsatistisfactory while 1\&2 is considered to be satisfactory. Postoperative pain was assessed using the visual analog scale from 0-10, where 0= no pain and 10= unbearable pain.

Data management Data were fed to the computer and analyzed using IBM SPSS software package version 20.0 (Armonk, NY: IBM Corp). Quantitative data were described using range (minimum and maximum), mean, SD, and median. Significance of the obtained results was judged at the 5% level.

02

Conditions studied

  • Renal Injury
  • Child, Only

Keywords

  • radical nephrectomy
03

In context

Lead sponsor

Alexandria University is the lead sponsor of 569 studies on the registry; 125 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients aged 5-10 years undergoing elective RN

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
75 participants (actual)

Study arms

  • Active comparator
    Group (C)

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

    Drug: bupivacaine

  • Active comparator
    Group (D)

    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

  • Placebo comparator
    Group (P)

    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

  • DrugDexmedetomidine

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

    Also known as: preceedex

  • Drugbupivacaine

    0.25% bupivacaine is injected in the caudal epidural space

  • Drugnormal Saline

    injection of normal Saline

    Also known as: 0.9 % Nacl

06

What researchers measure

Primary outcomes

  1. cystatin C

    Early biomarkers in detection of renal impairment

    Time frame: immediately after induction

  2. cystatin C

    Early biomarkers in detection of renal impairment

    Time frame: after 12 hours post-operatively

  3. NGAL

    Early biomarkers in detection of renal impairment

    Time frame: immediately after induction

  4. NGAL

    Early biomarkers in detection of renal impairment

    Time frame: after 12 hours post-operatively

Secondary outcomes

  1. serum creatinine

    conventional renal function tests

    Time frame: immediately after induction

  2. serum creatinine

    conventional renal function tests

    Time frame: after 12 hours post-operatively

  3. creatinine clearance

    conventional renal function tests

    Time frame: immediately after induction

  4. creatinine clearance

    conventional renal function tests

    Time frame: after 12 hours post-operatively

  5. sedation score

    indicator for post operative alertness, . Sedation level: Agitated = 4, Awake= 3, Drowsy= 2, Asleep= 1. A sedation score of 3 \& above was considered as unsatisfactory while 1 \& 2 is considered to be satisfactory.

    Time frame: 5 mins post-operative

  6. sedation score

    indicator for post operative alertness,. Sedation level: Agitated = 4, Awake= 3, Drowsy= 2, Asleep= 1. A sedation score of 3 \& above was considered as unsatisfactory while 1 \& 2 is considered to be satisfactory.

    Time frame: 60 mins post-operative

07

Study locations

1 site
  • Haasan Elhoshy
    Alexandria, 21615, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05271253
Lead sponsor
Alexandria University
Responsible party
Sponsor
First posted
Mar 9, 2022
Start date
Apr 10, 2021
Primary completion
Nov 29, 2021
Completion
Jan 15, 2022
Last update
Mar 9, 2022

Study contacts

Hassan S ElHoshy, lecturer
study chair · Alexandria University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion