Postoperative Nausea and VomitingFLUIDVOMITNCT03485443
Effects of Fluid Infusion on Postoperative Vomiting in Pediatric Patients Undergoing Otorhinolaryngological Surgery
A study testing %0.9 NaCl 10ml/kg and %0.9 NaCl 20ml/kg in people with Postoperative Nausea and Vomiting, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- %0.9 NaCl 10ml/kg and %0.9 NaCl 20ml/kg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 2-14 years
- ASA I-II
Who cannot join
- Gastroesafageal reflu
- Premedication antiemetic
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adnan Menderes University Training and Research Hospital
Aydin, 09100
About this study
Official title: Effects of Intraoperative Fluid Infusion on Postoperative Vomiting in Pediatric Patients Undergoing Otorhinolaryngological Surgery
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.
Read the 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
- Being tested
- %0.9 NaCl 10ml/kg, %0.9 NaCl 20ml/kg
- Keywords
- fluid infusion, vomiting, otorhinolaringology
- Medical subject headings
- Postoperative Nausea and Vomiting, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
%0.9 NaCl 10ml/kgDrug
Fluid administration
%0.9 NaCl 20ml/kgDrug
Fluid administration
| Study group | Role | What they receive |
|---|---|---|
| Group I (%0.9 NaCl 10ml/kg) | Active comparator | 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. Receives: Drug: %0.9 NaCl 10ml/kg |
| Group II (%0.9 NaCl 20ml/kg) | Active comparator | 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. Receives: Drug: %0.9 NaCl 20ml/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
vomiting
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
Measured: postoperative first 30 min
Secondary outcomes (1)
Pain
Intensity of pain was evaluated using Children's Hospital East Ontario Pain Scale (CHEOPS).
Measured: postoperative first 30 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start1 Jan 2018
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SİNAN YILMAZ, Aydin Adnan Menderes University
- Investigators
- sinan yılmaz, Principal investigator, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485443
- Sponsor's protocol ID
- FLUID-VOMITING
- Acronym
- FLUIDVOMIT
- Status last verified
- Dec 2018
- First submitted
- 26 Mar 2018
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intraoperative Fluid Infusion on Postoperative Vomiting in Pediatric Patients Undergoing Otorhinolaryngological Surgery
- ClinicalTrials.gov ID
- NCT03485443
- Acronym / sponsor ID
- FLUIDVOMIT / FLUID-VOMITING
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- fluid infusion, vomiting, otorhinolaringology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 2 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (%0.9 NaCl 10ml/kg) | Active comparator | Drug: %0.9 NaCl 10ml/kgThe 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 II (%0.9 NaCl 20ml/kg) | Active comparator | Drug: %0.9 NaCl 20ml/kgThe 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. |
Who may qualify
- Ages
- 2 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 2-14 years
- ASA I-II
Key exclusion criteria (2 listed)
- Gastroesafageal reflu
- Premedication antiemetic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| %0.9 NaCl 10ml/kgFluid administration | Drug | Group I (%0.9 NaCl 10ml/kg) |
| %0.9 NaCl 20ml/kgFluid administration | Drug | Group II (%0.9 NaCl 20ml/kg) |
Primary outcome
vomiting
Time frame: postoperative first 30 min
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
1 secondary outcome
Pain
Time frame: postoperative first 30 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sinan yılmaz principal investigator
Aydin Adnan Menderes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing %0.9 NaCl 10ml/kg and %0.9 NaCl 20ml/kg in people with Postoperative Nausea and Vomiting, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vomiting (time frame: postoperative first 30 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2018.