Effect of Intraoperative Crystalloid Volume on Postoperative Vomiting

NCT ID: NCT02177201

Last Updated: 2016-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-08-31

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.

Conditions

Postoperative Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1

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

Group Type: SHAM_COMPARATOR

Group 1

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Group 2

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aydin Adnan Menderes University

OTHER

Sponsor Role: lead

Responsible Party

SİNAN YILMAZ

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SİNAN YILMAZ, MD

Role: STUDY_DIRECTOR

Adnan Menderes University,Faculty of Medicine, Department of Anesthesia

Locations

Adnan Menderes University Training and Research Hospital

Aydin, Aydın, Turkey (Türkiye)

Adnan Menders University

Aydin, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2013/255

Identifier Type: -

Identifier Source: org_study_id