Effect of Intraoperative Crystalloid Volume on Postoperative Vomiting (EICVPV)

Aydin Adnan Menderes University

Status: Completed

Conditions: Postoperative Vomiting

Treatments: Other: Group 1; Other: Group 2

Study type: Interventional

Funder types: Other

Identifiers

NCT02177201

2013/255

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 patients

Sex: All

Ages: 2 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

160 participants in 2 patient groups

Group 1

Sham Comparator group

Description:

intravenous administration of 10 ml/kg/h 0.9% saline solution

Treatment:

Other: Group 1

Group 2

Active Comparator group

Description:

intravenous administration of 20 ml/kg/h 0.9% saline solution

Treatment:

Other: Group 2