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Effect of Intraoperative Crystalloid Volume on Postoperative Vomiting (EICVPV)

Primary Purpose

Postoperative Vomiting

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Group 1
Group 2
Sponsored by
Aydin Adnan Menderes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Vomiting

Eligibility Criteria

2 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:ASA physical status I or II

  • Age 2-15 yr
  • Scheduled for elective tonsillectomy and/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

Sites / Locations

  • Adnan Menderes University Training and Research Hospital
  • Adnan Menders University

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

intravenous administration of 10 ml/kg/h 0.9% saline solution

intravenous administration of 20 ml/kg/h 0.9% saline solution

Outcomes

Primary Outcome Measures

Postoperative Vomiting
Presence of at least one episode of vomiting within the first 24 hours of postoperative is positive for definition

Secondary Outcome Measures

Full Information

First Posted
June 26, 2014
Last Updated
December 30, 2015
Sponsor
Aydin Adnan Menderes University
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1. Study Identification

Unique Protocol Identification Number
NCT02177201
Brief Title
Effect of Intraoperative Crystalloid Volume on Postoperative Vomiting
Acronym
EICVPV
Official Title
Effect of Intravenous Crystalloid Volume on Postoperative Nausea and Vomiting After Tonsillectomy and/or Adenoidectomy: a Prospective, Randomized, Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aydin Adnan Menderes University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Postoperative nausea and vomiting is very common in children undergone tonsillectomy and/or adenoidectomy. The purpose of this clinical trial is to evaluate the antiemetic effect of super-hydration with 0.9% saline in children undergoing specifically elective otorhinolaryngological surgery. Fluid intake reduces vomiting as seen following extended period of fasting that interrupts the perfusion in gut. Based on this knowledge, we hypothesized that administration of supplemental fluid would reduce the incidence of postoperative vomiting.
Detailed Description
At the initiation of the study, 160 patients we enrolled consecutively . Six of the patients were excluded according to the inclusion/exclusion criteria. Remaining one hundred fifty four were American Society of Anesthesia (ASA) I-II classified children , aged 2-15 yr, undergoing elective tonsillectomy, with or without adenoidectomy, under general anesthesia . Induction and maintenance of anesthesia were standardized with fentanyl, lidocaine, rocuronium and sevoflurane in nitrous oxide (N(2)O). Subjects were assigned to two groups administered with saline solution (%0.9 saline) at different rates; either 10 ml/kg/h or 20ml/kg/h delivery arms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Vomiting

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Sham Comparator
Arm Description
intravenous administration of 10 ml/kg/h 0.9% saline solution
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
intravenous administration of 20 ml/kg/h 0.9% saline solution
Intervention Type
Other
Intervention Name(s)
Group 1
Intervention Description
Intravenous access was established and 10 ml/kg/h 0.9% saline solution was delivered following the induction of anesthesia and until the end of the operation.
Intervention Type
Other
Intervention Name(s)
Group 2
Intervention Description
Intravenous access was established and 20 ml/kg/h 0.9% saline solution was delivered following the induction of anesthesia and until the end of the operation.
Primary Outcome Measure Information:
Title
Postoperative Vomiting
Description
Presence of at least one episode of vomiting within the first 24 hours of postoperative is positive for definition
Time Frame
First 24 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:ASA physical status I or II Age 2-15 yr Scheduled for elective tonsillectomy and/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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SİNAN YILMAZ, MD
Organizational Affiliation
Adnan Menderes University,Faculty of Medicine, Department of Anesthesia
Official's Role
Study Director
Facility Information:
Facility Name
Adnan Menderes University Training and Research Hospital
City
Aydın
ZIP/Postal Code
09100
Country
Turkey
Facility Name
Adnan Menders University
City
Aydın
ZIP/Postal Code
09100
Country
Turkey

12. IPD Sharing Statement

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Effect of Intraoperative Crystalloid Volume on Postoperative Vomiting

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