Effect of Intraoperative Crystalloid Volume on Postoperative Vomiting

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Intravenous Crystalloid Volume on Postoperative Nausea and Vomiting After Tonsillectomy and/or Adenoidectomy: a Prospective, Randomized, Controlled Study

Conditions
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Postoperative Vomiting

Intervention / Treatment
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* Other: Group 1
* Other: Group 2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Group 1<br>intravenous administration of 10 ml/kg/h 0.9% saline solution | Other: Group 1<br>* 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.<br>|
| Active Comparator: Group 2<br>intravenous administration of 20 ml/kg/h 0.9% saline solution | Other: Group 2<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Vomiting | Presence of at least one episode of vomiting within the first 24 hours of postoperative is positive for definition | First 24 hours postoperative |