Effect of Intraoperative Crystalloid Volume on Postoperative Vomiting

Postoperative Vomiting Clinical Trial

— EICVPV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02177201
• Other study ID #: 2013/255
• Status: Completed
• Phase: N/A
• First received: June 26, 2014
• Last updated: December 30, 2015
• Start date: August 2013
• Est. completion date: August 2014

Study information

• Verified date: August 2015
• Source: Adnan Menderes University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: August 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 15 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Postoperative Nausea and Vomiting
• Postoperative Vomiting
• Vomiting

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Adnan Menderes University Training and Research Hospital	Aydin
Turkey	Adnan Menders University	Aydin

Sponsors (1)

Lead Sponsor	Collaborator
Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No