NCT02177201

Effect of Intraoperative Crystalloid Volume on Postoperative Vomiting

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Aydin Adnan Menderes University · Academic / Other
• Sex: All
• Age: 2 Years – 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Vomiting

Interventions

Type	Name	Description
OTHER	Group 1	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.
OTHER	Group 2	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.

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-07-01
• Completion: 2014-08-01
• First posted: 2014-06-27
• Last updated: 2016-02-01
• Results posted: 2016-02-01

Locations

2 sites across 1 country: Turkey (Türkiye)