Adverse Effect of Other General AnestheticsNCT02486926
The Effects of Remifentanil and Remifentanil-Alfentanil Administration in Children
A study testing Sevoflurane, Remifentanil and Alfentanil in people with Adverse Effect of Other General Anesthetics, run by Hallym University Medical Center.
Trial summary
Sevoflurane is widely and frequently used in pediatric anesthesia due to its non-irritating airway properties, rapid induction and emergence. However, it is associated with emergence agitation (EA) in children. Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Adverse Effect of Other General Anesthetics
- What is being tested?
- Sevoflurane, Remifentanil and Alfentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Jan 2014
- 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 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children who were scheduled to undergo ophthalmic surgery under general anesthesia
Who cannot join
- developmental delay, neurologic or psychologic disease,
- history of sleep apnea,
- or history of general anesthesia
About this study
Official title: The Effects of Remifentanil and Remifentanil-Alfentanil Administration on Emergence Agitation After Brief Ophthalmic Surgery in Children
Sevoflurane is widely and frequently used in pediatric anesthesia due to its non-irritating airway properties, rapid induction and emergence. However, it is associated with emergence agitation (EA) in children. EA may cause injury to the child or to the surgical site and is a cause of stress to both caregivers and families. Various pharmacologic agents have been suggested to reduce EA. But the effect of remifentanil on EA is still controversial. This study was designed to compare the effects of remifentanil and remifentanil combining alfentanil on EA in children undergoing ophthalmic surgery with sevoflurane anesthesia.
Read the detailed description
One hundred and two children, aged 3-9 years, undergoing ophthalmic surgery were studied. General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane. At the time of separation from parents, separation score was recorded. When the children have a separation score of three or four point, they received half dose of thiopental before going to the operation room. They randomly assigned to group S (sevoflurane alone) or group R (sevoflurane with remifentanil infusion at the rate of 0.1 ㎍/kg/min) or group A (sevoflurane with remifentanil infusion and intravenous injection of alfentanil 5 ㎍/kg 10 min before the end of surgery). Mean arterial pressure (MAP), heart rate (HR) and sevoflurane concentration were checked every 15 minutes after induction of anesthesia. Time to extubation from discontinuation of sevoflurane inhalation was measured. Time to discharge from postanesthesia care unit (PACU) was assessed with postanesthetic Aldrete recovery score. Emergence agitation scoring system was used to evaluate the incidence and severity of EA.
- Being tested
- Sevoflurane, Remifentanil, Alfentanil, Thiopental, Rocuronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneOther
Anesthesia of patients was maintained only with sevoflurane.
RemifentanilDrug
Also called Ultiva
Anesthesia of patients was maintained with both sevoflurane and continuous remifentanil infusion.
AlfentanilDrug
Anesthesia was maintained with both sevoflurane and continuous infusion of remifentanil. Alfentanil was administrated (5ug/kg) to patients 10 minutes before the end of surgery.
ThiopentalDrug
Also called Pentothal sodium
General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients.
RocuroniumDrug
Also called Esmeron
General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients.
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane | Placebo comparator | Anesthesia was maintained with sevoflurane,and the incidence and severity of emergence agitation was investigated. Receives: Other: Sevoflurane; Drug: Thiopental; Drug: Rocuronium |
| Remifentanil | Active comparator | Anesthesia was maintained with sevoflurane and remifentanil. The incidence and severity of emergence agitation was compared with sevoflurane group. Receives: Other: Sevoflurane; Drug: Remifentanil; Drug: Thiopental; Drug: Rocuronium |
| Alfentanil | Active comparator | Anesthesia was maintained with sevoflurane and remifentanil, and alfentanil was administered 10 min before the end of surgery.
The incidence and severity of emergence agitation was compared with sevoflurane group. Receives: Other: Sevoflurane; Drug: Remifentanil; Drug: Alfentanil; Drug: Thiopental; Drug: Rocuronium |
| Thiopental | Other | General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients. Receives: Other: Sevoflurane; Drug: Remifentanil; Drug: Alfentanil; Drug: Thiopental; Drug: Rocuronium |
| Rocuronium | Other | General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients. Receives: Other: Sevoflurane; Drug: Remifentanil; Drug: Alfentanil; Drug: Thiopental; Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of emergence agitation
Measured: during recovery time in PACU (within 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startNov 2012
- Primary completionJul 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adverse Effect of Other General AnestheticsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hallym University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Soo Kyung Lee, M.D., Study chair, Department of Anesthesiology and Pain Medicine, Hallyum University Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486926
- Sponsor's protocol ID
- 2012-I069
- Status last verified
- Jul 2015
- First submitted
- 29 Jun 2015
- Last updated
- 7 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ozturk T, Erbuyun K, Keles GT, Ozer M, Yuksel H, Tok D. The effect of remifentanil on the emergence characteristics of children undergoing FBO for bronchoalveolar lavage with sevoflurane anaesthesia. Eur J Anaesthesiol. 2009 Apr;26(4):338-42. doi: 10.1097/EJA.0b013e32831de50d.
PubMed 19401665Choi YH, Kim KM, Lee SK, Kim YS, Kim SJ, Hwang WS, Chung JH. Effects of remifentanil and remifentanil-alfentanil administration on emergence agitation after brief ophthalmic surgery in children. BMC Anesthesiol. 2016 Aug 2;16(1):50. doi: 10.1186/s12871-016-0213-2.
PubMed 27484339
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Remifentanil and Remifentanil-Alfentanil Administration on Emergence Agitation After Brief Ophthalmic Surgery in Children
- ClinicalTrials.gov ID
- NCT02486926
- Acronym / sponsor ID
- 2012-I069
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Hallym University Medical CenterUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 1 Jul 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.
Sevoflurane is widely and frequently used in pediatric anesthesia due to its non-irritating airway properties, rapid induction and emergence. However, it is associated with emergence agitation (EA) in children. EA may cause injury to the child or to the surgical site and is a cause of stress to both caregivers and families. Various pharmacologic agents have been suggested to reduce EA. But the effect of remifentanil on EA is still controversial. This study was designed to compare the effects of remifentanil and remifentanil combining alfentanil on EA in children undergoing ophthalmic surgery with sevoflurane anesthesia.
Detailed description
One hundred and two children, aged 3-9 years, undergoing ophthalmic surgery were studied. General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane. At the time of separation from parents, separation score was recorded. When the children have a separation score of three or four point, they received half dose of thiopental before going to the operation room. They randomly assigned to group S (sevoflurane alone) or group R (sevoflurane with remifentanil infusion at the rate of 0.1 ㎍/kg/min) or group A (sevoflurane with remifentanil infusion and intravenous injection of alfentanil 5 ㎍/kg 10 min before the end of surgery). Mean arterial pressure (MAP), heart rate (HR) and sevoflurane concentration were checked every 15 minutes after induction of anesthesia. Time to extubation from discontinuation of sevoflurane inhalation was measured. Time to discharge from postanesthesia care unit (PACU) was assessed with postanesthetic Aldrete recovery score. Emergence agitation scoring system was used to evaluate the incidence and severity of EA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane | Placebo comparator | Other: Sevoflurane, Drug: Thiopental, Drug: RocuroniumAnesthesia was maintained with sevoflurane,and the incidence and severity of emergence agitation was investigated. |
| Remifentanil | Active comparator | Other: Sevoflurane, Drug: Remifentanil, Drug: Thiopental, Drug: RocuroniumAnesthesia was maintained with sevoflurane and remifentanil. The incidence and severity of emergence agitation was compared with sevoflurane group. |
| Alfentanil | Active comparator | Other: Sevoflurane, Drug: Remifentanil, Drug: Alfentanil, Drug: Thiopental, Drug: RocuroniumAnesthesia was maintained with sevoflurane and remifentanil, and alfentanil was administered 10 min before the end of surgery. The incidence and severity of emergence agitation was compared with sevoflurane group. |
| Thiopental | Other | Other: Sevoflurane, Drug: Remifentanil, Drug: Alfentanil, Drug: Thiopental, Drug: RocuroniumGeneral anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients. |
| Rocuronium | Other | Other: Sevoflurane, Drug: Remifentanil, Drug: Alfentanil, Drug: Thiopental, Drug: RocuroniumGeneral anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients. |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children who were scheduled to undergo ophthalmic surgery under general anesthesia
Key exclusion criteria (3 listed)
- developmental delay, neurologic or psychologic disease,
- history of sleep apnea,
- or history of general anesthesia
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 |
|---|---|---|
| SevofluraneAnesthesia of patients was maintained only with sevoflurane. | Other | Alfentanil, Remifentanil, Rocuronium, Sevoflurane, Thiopental |
| RemifentanilAlso: UltivaAnesthesia of patients was maintained with both sevoflurane and continuous remifentanil infusion. | Drug | Alfentanil, Remifentanil, Rocuronium, Thiopental |
| AlfentanilAnesthesia was maintained with both sevoflurane and continuous infusion of remifentanil. Alfentanil was administrated (5ug/kg) to patients 10 minutes before the end of surgery. | Drug | Alfentanil, Rocuronium, Thiopental |
| ThiopentalAlso: Pentothal sodiumGeneral anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients. | Drug | Alfentanil, Remifentanil, Rocuronium, Sevoflurane, Thiopental |
| RocuroniumAlso: EsmeronGeneral anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients. | Drug | Alfentanil, Remifentanil, Rocuronium, Sevoflurane, Thiopental |
Primary outcome
the incidence of emergence agitation
Time frame: during recovery time in PACU (within 1 hour)
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 7 Jul 2015.
- Background: PubMed 19401665Ozturk T, Erbuyun K, Keles GT, Ozer M, Yuksel H, Tok D. The effect of remifentanil on the emergence characteristics of children undergoing FBO for bronchoalveolar lavage with sevoflurane anaesthesia. Eur J Anaesthesiol. 2009 Apr;26(4):338-42. doi: 10.1097/EJA.0b013e32831de50d.
- Derived from this study: PubMed 27484339Choi YH, Kim KM, Lee SK, Kim YS, Kim SJ, Hwang WS, Chung JH. Effects of remifentanil and remifentanil-alfentanil administration on emergence agitation after brief ophthalmic surgery in children. BMC Anesthesiol. 2016 Aug 2;16(1):50. doi: 10.1186/s12871-016-0213-2.
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.
Soo Kyung Lee, M.D. study chair
Department of Anesthesiology and Pain Medicine, Hallyum University Sacred Heart Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane, Remifentanil and Alfentanil in people with Adverse Effect of Other General Anesthetics, run by Hallym University Medical Center.
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 7 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
the incidence of emergence agitation (time frame: during recovery time in PACU (within 1 hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02486926, which also lists 2 linked publications.
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 7 Jul 2015.