Effect of Intraoperative Crystalloid Volume on Postoperative Vomiting

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.

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Key information

Conditions

Postoperative Vomiting Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

2 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Adnan Menderes University Training and Research Hospital, Aydin, Aydın, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group 1

Other

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.

Group 2

Other

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 outcomes

Postoperative Vomiting

Time frame: First 24 hours postoperative

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

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

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

Acronym: EICVPV

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Jun 27, 2014
Registry last updated: Feb 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed