StrabismusNCT02455401
Effect of Remifentanil on Postoperative Vomiting in Pediatric Strabismus Surgery
A study testing High dose remifentanil, Low dose remifentanil and No remifentanil in people with Strabismus, run by Inje University at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the effect of remifentanil on postoperative vomiting in children undergoing strabismus surgery during sevoflurane anesthesia. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Strabismus
- What is being tested?
- High dose remifentanil, Low dose remifentanil and No remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2015to Nov 2017
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children undergoing elective strabismus surgery under sevoflurane anesthesia
Who cannot join
- children who experienced postoperative retching or vomiting
- children who have taken anti-emetic medications within 24 hours before surgery
- children who experienced motion sickness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Remifentanil on Postoperative Vomiting in Children Undergoing Strabismus Surgery During Sevoflurane Anesthesia
The purpose of this study is to compare the effect of remifentanil on postoperative vomiting in children undergoing strabismus surgery during sevoflurane anesthesia.
Read the detailed description
Children undergoing strabismus surgery frequently experience postoperative vomiting (POV) that results in dehydration, aspiration pneumonia, bleeding, delayed hospital discharge, as well as decreased parental satisfaction and an unpleasant experience for the pediatric patients. Although administration of perioperative opioids increases POV incidence, remifentanil has less affect the incidence of POV than other opioids such as fentanyl. However, there are few study that evaluate the effects of remifentanil on the incidence of POV. Therefore, the investigators will conducted the study that the effects of remifentanil on the incidence of POV in children undergoing strabismus surgery during sevoflurane anesthesia. One hundred five children from 3 to 6 yr of age, ASA physical status 1 or 2 were assigned randomly selected to one of three groups: high dose remifentanil group (bolus 1.0 mcg/kg; infusion 0.1 mcg/kg/min), low remifentanil group (bolus 0.5 mcg/kg; infusion 0.1 mcg/kg/min), or no remifentanil group (no remifentanil administration). Primary endpoint, the incidence of POV for 24 hours postoperatively, will be compared between three study groups.
- Conditions
- Strabismus
- Being tested
- High dose remifentanil, Low dose remifentanil, No remifentanil
- Keywords
- Postoperative Vomiting
- Medical subject headings
- Strabismus, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High dose remifentanilDrug
Also called High dose remifentanil (Ultiva,Glaxosmithkline, UK)
Intervention: continuously intravenous infusion of remifentanil 0.1 mcg/kg/min after bolus injection of remifentanil 1.0 mcg/kg for 2 minutes
Low dose remifentanilDrug
Also called Low dose remifentanil (Ultiva, Glaxosmithkline, UK)
Intervention: continuously intravenous infusion of remifentanil 0.1 mcg/kg/min after bolus injection of remifentanil 0.5 mcg/kg for 2 minutes
No remifentanilDrug
Also called No remifentanil (Ultiva, Glaxosmithkline, UK)
Intervention: no remifentanil will be administrated
| Study group | Role | What they receive |
|---|---|---|
| high dose remifentanil group | Experimental | Intervention: high dose remifentanil will be administrated. Receives: Drug: High dose remifentanil |
| low dose remifentanil group | Experimental | Intervention: low dose remifentanil will be administrated Receives: Drug: Low dose remifentanil |
| No remifentanil group | Placebo comparator | Intervention: no remifenatnil will be administrated Receives: Drug: No remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postoperative vomiting in PACU and surgical ward
Vomiting is expulsion of gastric contents. Incidence of vomiting will be compared between the groups.
Measured: from extubation to 24 hours
Secondary outcomes (2)
postoperative pain in PACU and surgical ward
Postoperative pain will be assessed using Faces Pain Rating Scale.
Measured: from extubation to 24 hours
postoperative emergence agitation
Postoperative emergence agitation will be assessed using Pediatric Anesthesia Emergence Delirium.
Measured: from extubation to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startMay 2015
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrabismusStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ki Hwa Lee, Inje University
- Investigators
- Lee, M.D., Principal investigator, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455401
- Sponsor's protocol ID
- 2015-024
- Status last verified
- Nov 2017
- First submitted
- 19 May 2015
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Remifentanil on Postoperative Vomiting in Children Undergoing Strabismus Surgery During Sevoflurane Anesthesia
- ClinicalTrials.gov ID
- NCT02455401
- Acronym / sponsor ID
- 2015-024
- Conditions
- Strabismus
- Keywords
- Postoperative Vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 27 May 2015 (estimated)
- 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.
The purpose of this study is to compare the effect of remifentanil on postoperative vomiting in children undergoing strabismus surgery during sevoflurane anesthesia.
Detailed description
Children undergoing strabismus surgery frequently experience postoperative vomiting (POV) that results in dehydration, aspiration pneumonia, bleeding, delayed hospital discharge, as well as decreased parental satisfaction and an unpleasant experience for the pediatric patients. Although administration of perioperative opioids increases POV incidence, remifentanil has less affect the incidence of POV than other opioids such as fentanyl. However, there are few study that evaluate the effects of remifentanil on the incidence of POV. Therefore, the investigators will conducted the study that the effects of remifentanil on the incidence of POV in children undergoing strabismus surgery during sevoflurane anesthesia. One hundred five children from 3 to 6 yr of age, ASA physical status 1 or 2 were assigned randomly selected to one of three groups: high dose remifentanil group (bolus 1.0 mcg/kg; infusion 0.1 mcg/kg/min), low remifentanil group (bolus 0.5 mcg/kg; infusion 0.1 mcg/kg/min), or no remifentanil group (no remifentanil administration). Primary endpoint, the incidence of POV for 24 hours postoperatively, will be compared between three study groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| high dose remifentanil group | Experimental | Drug: High dose remifentanilIntervention: high dose remifentanil will be administrated. |
| low dose remifentanil group | Experimental | Drug: Low dose remifentanilIntervention: low dose remifentanil will be administrated |
| No remifentanil group | Placebo comparator | Drug: No remifentanilIntervention: no remifenatnil will be administrated |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children undergoing elective strabismus surgery under sevoflurane anesthesia
Key exclusion criteria (3 listed)
- children who experienced postoperative retching or vomiting
- children who have taken anti-emetic medications within 24 hours before surgery
- children who experienced motion sickness
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 |
|---|---|---|
| High dose remifentanilAlso: High dose remifentanil (Ultiva,Glaxosmithkline, UK)Intervention: continuously intravenous infusion of remifentanil 0.1 mcg/kg/min after bolus injection of remifentanil 1.0 mcg/kg for 2 minutes | Drug | high dose remifentanil group |
| Low dose remifentanilAlso: Low dose remifentanil (Ultiva, Glaxosmithkline, UK)Intervention: continuously intravenous infusion of remifentanil 0.1 mcg/kg/min after bolus injection of remifentanil 0.5 mcg/kg for 2 minutes | Drug | low dose remifentanil group |
| No remifentanilAlso: No remifentanil (Ultiva, Glaxosmithkline, UK)Intervention: no remifentanil will be administrated | Drug | No remifentanil group |
Primary outcome
incidence of postoperative vomiting in PACU and surgical ward
Time frame: from extubation to 24 hours
Vomiting is expulsion of gastric contents. Incidence of vomiting will be compared between the groups.
2 secondary outcomes
postoperative pain in PACU and surgical ward
Time frame: from extubation to 24 hours
postoperative emergence agitation
Time frame: from extubation to 24 hours
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 14 Nov 2017.
- Individual participant dataSharing planned: No
Related trials for Strabismus
Not yet recruiting
Comparative Study Of Combined Recession-Resection And Fenestration of Superior Rectus Muscle for Treatment of Dissociated Vertical Deviation
Dissociated Vertical Deviation
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
Not yet recruitingPhase 4
Effect of Ketamine-Propofol Total Intravenous Anesthesia Versus Sevoflurane-Based Anesthesia on Postoperative Vomiting in Children Undergoing Strabismus Surgery
Postoperative Vomiting, Postoperative Nausea and Vomiting
RecruitingObservational study
Eye-Hand Cross-Dominance and Upper Extremity Performance in Volleyball Players
Volleyball Player
Recruiting
Vision Therapy Versus Prism Treatment in Small-angle Acute Acquired Concomitant Esotropia
Esotropia
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.
Lee, M.D. principal investigator
Inje 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 High dose remifentanil, Low dose remifentanil and No remifentanil in people with Strabismus, run by Inje University at 1 site in South Korea.
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 1 inclusion and 3 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 14 Nov 2017. 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
incidence of postoperative vomiting in PACU and surgical ward (time frame: from extubation to 24 hours). 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 14 Nov 2017.