Effect of Intraoperative Crystalloid Volume on Postoperative Vomiting

Not Applicable

Completed

• Conditions: Postoperative Vomiting
• Interventions: Other: Group 1; Other: Group 2

• Registration Number: NCT02177201
• Lead Sponsor: Aydin Adnan Menderes University

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.

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2014-06-26
• Study First Submitted QC: 2014-06-26
• Study First Posted: 2014-06-27
• Primary Completion: 2014-07
• Study Completion: 2014-08
• Results First Submitted: 2015-01-19
• Status Verified: 2015-08
• Results First Submitted QC: 2015-12-30
• Last Update Submitted: 2015-12-30
• Results First Posted: 2016-02-01
• Last Update Posted: 2016-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Group 1	intravenous administration of 10 ml/kg/h 0.9% saline solution
Group 2	Group 2	intravenous administration of 20 ml/kg/h 0.9% saline solution

Primary Outcome Measures

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

Trial Locations

Locations (2)

Adnan Menders University; 🇹🇷 Aydın, Turkey

Adnan Menderes University Training and Research Hospital; 🇹🇷 Aydın, Turkey