Effect of Intraoperative Crystalloid Volume on Postoperative Vomiting

NCT02177201 | Completed Results DMC

• 1 other identifier: 2013/255
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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.

Conditions

Postoperative Vomiting

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group 1

SHAM COMPARATOR

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

Other: Group 1

Group 2

ACTIVE COMPARATOR

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

Other: Group 2

Interventions

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 1

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.

Group 2

Eligibility Criteria

• Age: 2 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 2-15 yr
• Scheduled for elective tonsillectomy and/or adenotonsillectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (2)

Adnan Menderes University Training and Research Hospital

Aydin, Aydın, 09100, Turkey (Türkiye)

Location

Adnan Menders University

Aydin, 09100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Sinan Yılmaz
• Organization: Adnan Menders University, Anesthesiology and Reanimation Department

dr_snnylmz@hotmail.com

+905055954374

Study Officials

• SİNAN YILMAZ, MD

  Adnan Menderes University,Faculty of Medicine, Department of Anesthesia

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 26, 2014
• First Posted: June 27, 2014
• Study Start: August 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: August 1, 2014
• Last Updated: February 1, 2016
• Results First Posted: February 1, 2016

Record last verified: 2015-08

Locations

TU (2)