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Renal Function During Pediatric Anesthesia

Primary Purpose

Renal Failure, Anesthesia

Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
Sevoflurane
propofol
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Renal Failure

Eligibility Criteria

1 Year - 12 Years (Child)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Eligible for hypospadia surgery.

Exclusion Criteria:

  • American Association of Anesthesiology class above 2
  • Weight above 50 kg or below 10 kg
  • Hypersensitivity towards the anesthetic agents (difficult peanut or soy allergy)
  • Inability for parent to understand study information

Sites / Locations

  • Akademiska university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Propofol

sevoflurane

Arm Description

Continuous infusion during surgery. Individual dosage.

Inhalational anesthetic during surgery. Individual dosage

Outcomes

Primary Outcome Measures

urine output during anesthesia

Secondary Outcome Measures

urine output postoperatively
sodium excretion postoperatively
Changes in aldosterone, angiotensin II, arginine-vasopressin during surgery
Comparison of blood samples of fluid balance regulatory hormones collected at baseline, during surgery and 1 hour + 3 hours postoperatively
Changes in aldosterone, angiotensin II, arginine-vasopressin postoperatively
Comparison of blood samples of fluid balance regulatory hormones collected at baseline, during surgery and 1 hour + 3 hours postoperatively
Sodium excretion during anesthesia

Full Information

First Posted
October 5, 2015
Last Updated
November 2, 2020
Sponsor
Uppsala University
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1. Study Identification

Unique Protocol Identification Number
NCT02571426
Brief Title
Renal Function During Pediatric Anesthesia
Official Title
The Influence of Propofol and Sevoflurane Anesthesia on Water and Sodium Retention in Children
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
It is known that volatile anesthesia, such as sevoflurane, retain water and that this appears more pronounced in children. However, the mechanisms for this effect is unknown and it is not clear if the commonly used anesthetic propofol does the same. In this study the investigators want to compare the fluid and electrolyte conserving effects of sevoflurane and propofol in a pediatric setting and also investigate humoral changes induced by these anesthetics.
Detailed Description
Prior studies by the investigators research group have shown water and sodium retention in experimental animals undergoing sevoflurane anesthesia. Preliminary data suggest that this is not as obvious with propofol anesthesia. The investigators aim to study if this difference is present in children. Subjects are collected from ordinary routine operations of hypospadia. By routine, all boys undergoing this surgery get a sacral blockade and a urine catheter. The children are randomized to either sevoflurane or propofol anesthesia. Before or immediately after induction of anesthesia baseline blood samples are collected for analysis of sodium, potassium, creatinine, osmolality, angiotensin II, arginine-vasopressin and aldosterone. Perioperative fluids are started, a balanced glucose infusion with 132mmol sodium content, covering basal fluid need + 20%. This infusion is continued until the end of the protocol at the ward. At the induction of anesthesia the investigators start measuring urine output every 20th minute. The same blood samples as above are collected again during mid-operation. At the end of anesthesia the investigators collect all the urine and send a sample for urine analysis of sodium, potassium, osmolality and creatinine. In the postoperative ward the investigators again start collecting urine every 20 minutes for 120 minutes. All urine after 120 minutes are collected, and a sample sent for analysis. After 60 minutes at the postoperative ward, blood samples are again collected for analysis. In the childrens ward the protocol for the postoperative ward is repeated, with urine collection and sample, as well as blood samples. After 120 minutes the protocol ends.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure, Anesthesia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propofol
Arm Type
Active Comparator
Arm Description
Continuous infusion during surgery. Individual dosage.
Arm Title
sevoflurane
Arm Type
Active Comparator
Arm Description
Inhalational anesthetic during surgery. Individual dosage
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
sevorane
Intervention Description
anesthetic agent
Intervention Type
Drug
Intervention Name(s)
propofol
Other Intervention Name(s)
diprivane
Intervention Description
anesthetic agent
Primary Outcome Measure Information:
Title
urine output during anesthesia
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
urine output postoperatively
Time Frame
4 hours
Title
sodium excretion postoperatively
Time Frame
4 hours
Title
Changes in aldosterone, angiotensin II, arginine-vasopressin during surgery
Description
Comparison of blood samples of fluid balance regulatory hormones collected at baseline, during surgery and 1 hour + 3 hours postoperatively
Time Frame
2 hours
Title
Changes in aldosterone, angiotensin II, arginine-vasopressin postoperatively
Description
Comparison of blood samples of fluid balance regulatory hormones collected at baseline, during surgery and 1 hour + 3 hours postoperatively
Time Frame
4 hours
Title
Sodium excretion during anesthesia
Time Frame
2 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Eligible for hypospadia surgery. Exclusion Criteria: American Association of Anesthesiology class above 2 Weight above 50 kg or below 10 kg Hypersensitivity towards the anesthetic agents (difficult peanut or soy allergy) Inability for parent to understand study information
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Micael Taavo, MD
Organizational Affiliation
Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akademiska university hospital
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden

12. IPD Sharing Statement

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Renal Function During Pediatric Anesthesia

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