NCT04474600

Brief Summary

This study investigates the influence of type of anesthesia on postoperative renal dysfunction in patients undergoing nephrectomy. The participants will be allocated to either the group receiving the total intravenous anesthesia (TIVA) using propofol or the group receiving the inhaled anesthetics using desflurane.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
324

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 17, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

July 20, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2024

Completed
Last Updated

December 2, 2024

Status Verified

November 1, 2024

Enrollment Period

3.6 years

First QC Date

July 7, 2020

Last Update Submit

November 27, 2024

Conditions

Nephrectomy

Keywords

AnesthesiaPropofolInhaled anestheticsAcute kidney injuryNephrectomy

Outcome Measures

Primary Outcomes (1)

  • the incidence of acute kidney injury

    acute kidney injury (diagnosed by KDIGO criteria)

    during the postoperative seven days

Secondary Outcomes (6)

  • serum creatinine

    postoperative day 1, 3, 14

  • estimated glomerular filtration rate

    postoperative day 1, 3, 14

  • biomarker of renal injury

    postoperative day 1, 3, 14

  • the incidence of postoperative complications

    during the postoperative two weeks

  • Length of hospital stay

    during the postoperative two weeks

  • +1 more secondary outcomes

Study Arms (2)

TIVA group

EXPERIMENTAL

Patients receiving the total intravenous anesthesia using propofol

Drug: Propofol

Inhalation group

ACTIVE COMPARATOR

Patients receiving inhalation anesthesia using desflurane

Drug: Desflurane

Interventions

PropofolDRUG

The induction and maintenance of anesthesia was performed by total intravenous anesthesia using propofol. In both groups, remifentanil is continuously infused throughout the surgery.

TIVA group
DesfluraneDRUG

The induction and maintenance of anesthesia was performed by inhalation anesthesia using desflurane. In both groups, remifentanil is continuously infused throughout the surgery.

Inhalation group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults patients scheduled for elective open nephrectomy

You may not qualify if:

  • Patients diagnosed with acute kidney injury preoperatively
  • Patients who have chronic kidney disease over stage 5 (estimated glomerular filtration rate \[eGFR\] \<15 ml/kg/1.73m2) or have regular hemodialysis preoperatively

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

PropofolDesflurane

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsEthyl EthersEthersMethyl EthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical assistant professor

Study Record Dates

First Submitted

July 7, 2020

First Posted

July 17, 2020

Study Start

July 20, 2020

Primary Completion

February 6, 2024

Study Completion

March 6, 2024

Last Updated

December 2, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)