Effects of Fluid Infusion on Postoperative Vomiting in Pediatric Patients Undergoing Otorhinolaryngological Surgery

NCT ID: NCT03485443

Last Updated: 2018-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2018-06-01

Brief Summary

Otorhinolaryngological surgery is one of the commonly applied procedures surgical treatments of children in the world. Postoperative vomiting (POV) is an important part of the management of pediatric anesthesia in this surgery that is also related with these surgical procedures. Postoperative vomiting is one of the most common complication of this surgery and may cause patients to receiving anesthesia again and stay longer in the hospital.The use of effective fluid therapy might be a safe way to reduce POV. There are many studies of fluid therapy adult patients on the other hands the number of children studies are limited.

The aim of this study was to evaluate the POV effect of intraoperative hydration with 0.9 NaCl solution in children undergoing otorhinolaryngological surgery.

Detailed Description

After institutional ethics committee approval and written informed parental consent, ASA physical status I or II, aged 2-14 year, who were undergoing elective day case otorhinolaryngological surgery under general anaesthesia, were screened for eligibility for enrollment in this prospective, randomized, double blind, placebo controlled study.

In the operating room, after routine monitoring, general anaesthesia was induced with %8 sevoflurane in 100% oxygen by a face mask with spontaneous ventilation.

Patients were randomly assigned to one of the two groups. Randomization was carried out using a computer-generated random numbers.

The control group (Group I) received ≤10 ml kg-1 h-1 and the high volüme group ( Group II) received >30 ml kg-1h-1 of intravenous %0.9 NaCl solution.Before tracheal intubation, all subjects received propofol 2:5mg kg-1, fentanyl 1µg kg-1 and rocuronium 0.6 mg kg-1.

After tracheal intubation, anaesthesia was maintained with 40% mixture of oxygen/nitrous oxide and 2% sevoflurane. The solution appears to be covered via an infusion pump was used. During anaesthesia, all patients received intravenous paracetamol 10 mg kg-1 for postoperative pain .

Following extubation, until the transfer of the patient from the time of the PACU nausea, vomiting or both were recorded..

Retching efforts in the PACU were recorded as nausea evaluated. Both nausea and vomiting were assessed on a four point scale: 0=no nausea/vomit, 1=mild nausea/vomit, patient not requesting metoclopramide, 2=nausea/vomit, patient requesting metoclopramide and 3=nausea/vomit resistant to treatment At the first episode of severely nause and vomiting, or both, a rescue antiemetic consisting of intravenous ondansetron was administered.

Intensity of pain was evaluated using Children's Hospital East Ontario Pain Scale (CHEOPS).

Knowledge collection for posoperative pain to PACU arrival and departure was performed by a postanesthesia care unit (PACU) nurses who blinded to the procedure the amount of fluid therapy.

Conditions

Postoperative Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group I (%0.9 NaCl 10ml/kg)

The group (Group 1) received 10 ml kg-1 throughout the entire surgical procedure.

Four point scale using scored vomiting. m CHEOPS Scale using scored between 0-10.

Group Type: ACTIVE_COMPARATOR

%0.9 NaCl 10ml/kg

Intervention Type: DRUG

Fluid administration

Group II (%0.9 NaCl 20ml/kg)

The group (Group 2) received 30 ml kg-1 throughout the entire surgical procedure.

Four point scale using scored vomiting. m CHEOPS Scale using scored between 0-10.

Group Type: ACTIVE_COMPARATOR

%0.9 NaCl 20ml/kg

Intervention Type: DRUG

Fluid administration

Interventions

%0.9 NaCl 10ml/kg

Fluid administration

Intervention Type: DRUG

%0.9 NaCl 20ml/kg

Fluid administration

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 2-14 years
• ASA I-II

Exclusion Criteria

• Gastroesafageal reflu
• Premedication antiemetic

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aydin Adnan Menderes University

OTHER

Sponsor Role: lead

Responsible Party

SİNAN YILMAZ

Adnan Menderes University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

sinan yılmaz

Role: PRINCIPAL_INVESTIGATOR

Aydin Adnan Menderes University

Locations

Adnan Menderes University Training and Research Hospital

Aydin, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

FLUID-VOMITING

Identifier Type: -

Identifier Source: org_study_id