Renal Function During Pediatric Anesthesia
The Influence of Propofol and Sevoflurane Anesthesia on Water and Sodium Retention in Children
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2015
Typical duration for phase_1
1 active site
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
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 5, 2015
CompletedFirst Posted
Study publicly available on registry
October 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedNovember 4, 2020
November 1, 2020
2.4 years
October 5, 2015
November 2, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
urine output during anesthesia
2 hours
Secondary Outcomes (5)
urine output postoperatively
4 hours
sodium excretion postoperatively
4 hours
Changes in aldosterone, angiotensin II, arginine-vasopressin during surgery
2 hours
Changes in aldosterone, angiotensin II, arginine-vasopressin postoperatively
4 hours
Sodium excretion during anesthesia
2 hours
Study Arms (2)
Propofol
ACTIVE COMPARATORContinuous infusion during surgery. Individual dosage.
sevoflurane
ACTIVE COMPARATORInhalational anesthetic during surgery. Individual dosage
Interventions
Eligibility Criteria
You may qualify if:
- Eligible for hypospadia surgery.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Akademiska university hospital
Uppsala, 75185, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Micael Taavo, MD
Uppsala University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff physician
Study Record Dates
First Submitted
October 5, 2015
First Posted
October 8, 2015
Study Start
October 1, 2015
Primary Completion
March 1, 2018
Study Completion
April 1, 2019
Last Updated
November 4, 2020
Record last verified: 2020-11