Renal Function During Pediatric Anesthesia

Anesthesia Clinical Trial

Official title:

The Influence of Propofol and Sevoflurane Anesthesia on Water and Sodium Retention in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02571426
• Other study ID #: SRC52320142569-1
• Status: Completed
• Phase: Phase 1
• Start date: October 2015
• Est. completion date: April 2019

Study information

• Verified date: November 2020
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2019
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 1 Year to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Renal Failure
• Renal Insufficiency

Intervention

Drug:
• Sevoflurane
anesthetic agent
• propofol
anesthetic agent

Locations

Country	Name	City	State
Sweden	Akademiska university hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urine output during anesthesia		2 hours
Secondary	urine output postoperatively		4 hours
Secondary	sodium excretion postoperatively		4 hours
Secondary	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	2 hours
Secondary	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	4 hours
Secondary	Sodium excretion during anesthesia		2 hours