Effect of Intravenous Fluid Therapy on Postoperative Vomi... | NCT01575600

Studies
Effect of Intravenous Fluid Therapy on Postoperative Vomiting in Children Undergoing Otorhinolaryngological Surgery

NCT01575600

Sponsor

Ignacio Cortínez F.

Status

Completed

Last Update Posted

May 10, 2012Estimated

Enrollment

100Actual

Phase

Phase 3

Conditions

Postoperative Vomiting

Interventions

Intraoperative lactated Ringer's solution

Countries

Chile

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2010

Primary Completion Date

Mar 2012Actual

Completion Date

Mar 2012Actual

First Submitted Date

Apr 10, 2012

First Submission Date that Met QC Criteria

Apr 10, 2012

First Posted Date

Apr 11, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2012

Last Update Posted Date

May 10, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ignacio Cortínez F., Profesor Asociado, Departamento de Anestesiología, Pontificia Universidad Catolica de ChileSponsor-Investigator

Lead Sponsor

Ignacio Cortínez F.OTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this randomized clinical trial is to evaluate the interaction of intravenous fluid therapy during otorhinolaryngological surgery, on postoperative vomiting. The hypothesis is that perioperative supplemental intravenous fluid administration reduces the incidence of postoperative vomiting.

Detailed Description

Postoperative vomiting is a common complication on pediatric surgery, especially otorhinolaryngological surgery. Is one of the main reasons of prolonged hospital stay, and also a cause of patient´s discomfort and an increase on hospitalization cost.

There are studies in adults with inconclusive results related to supplemental fluid therapy and decrease of postoperative nausea and vomiting. But, in recent years a study in children showed favorable results in strabismus surgery. The foundation of this study consist in that hypovolemia may possibly cause a decrease in perfusion causing intestinal hypoxia, which in turn increase the incidence of nausea and vomiting. The objective of this study is to observe the effect of supplemental fluid therapy on postoperative vomiting on otorhinolaryngological surgery.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
10 mL/kg/h lactated Ringer's solution	Active Comparator	Group 1, 10 mL/kg/h lactated Ringer's solution	Other: Intraoperative lactated Ringer's solution
30 mL/kg/h lactated Ringer's solution	Experimental	Group 2, 30 mL/kg/h lactated Ringer's solution	Other: Intraoperative lactated Ringer's solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intraoperative lactated Ringer's solution	Other	After induction, IV access was established and children were randomly allocated to receive one of two interventions: Group 1, 10 mL/kg/h lactated Ringer's solution; Group 2, 30 mL/kg/h lactated Ringer's solution.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vomiting at 24 hours postoperative	Presence of at least one episode of vomiting in the first 24 hours postoperative	First 24 hours postoperative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA physical status I or II
Age 1-12 yr
Scheduled for elective tonsillectomy or adenotonsillectomy

Exclusion Criteria:

History of diabetes
History of mental retardation
Obesity (BMI ≥95th percentile for age and sex)
Intake of antiemetic or psychoactive medication within 24 hours before surgery
Known gastroesophageal reflux

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Clinico Universidad Catolica		Santiago	Santiago Metropolitan		Chile

Condition Browse Module

MeSH Terms

ID	Term
D020250	Postoperative Nausea and Vomiting

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009325	Nausea

Browse Leaves

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Browse Branches

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