Respiratory ComplicationNCT01915108

Optimal Effect-site Concentration of Remifentanil for Inhibiting Response to Laryngeal Mask Airway (LMA) Removal

A study testing Remifentanil in people with Respiratory Complication, run by Sangjin Park.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study was designed to determine the optimal dose of remifentanil that can prevent the complications associated with the removal of LMA without delaying emergence. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Respiratory Complication
What is being tested?: Remifentanil
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 128 participants
Where: No sites listed yet
Study dates: Jul 2012to Jun 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

American Society of Anesthesiologists physical status 1 or 2
undergoing lower extremity surgery under general anesthesia

Who cannot join

suspected difficult airways
respiratory disease (chronic obstructive pulmonary disease, upper respiratory infection)
body mass index > 30 kg/m2
allergies to the study drugs
a history of gastric reflux

About this study

Official title: Optimal Effect-site Concentration of Remifentanil for Inhibiting Response to Laryngeal Mask Airway (LMA) Removal During Emergence From Sevoflurane-remifentanil Anesthesia

This study was designed to determine the optimal dose of remifentanil that can prevent the complications associated with the removal of LMA without delaying emergence.

Read the detailed description

Patients were randomly assigned to one of four groups. All patients received a predetermined effect-site concentrations (Ce) of remifentanil by target-controlled infusion (TCI) according to their group assignments (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml) from 10 minutes before the end of surgery to LMA removal. Airway complications (airway obstruction, desaturation, breath holding, and coughing), nausea, and vomiting were assessed during the emergence phase.

Conditions: Respiratory Complication
Being tested: Remifentanil

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RemifentanilDrug
Also called remifentanil (ultiva)
All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml).

Study groups in NCT01915108
Study group	Role	What they receive
group R0	No intervention	remifentanil Ce of 0 ng/ml
group R0.5	Active comparator	remifentanil Ce of 0.5 ng/ml Receives: Drug: Remifentanil
group R1.0	Active comparator	remifentanil Ce of 1.0 ng/ml Receives: Drug: Remifentanil
group R1.5	Active comparator	remifentanil Ce of 1.5 ng/ml Receives: Drug: Remifentanil

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients With Adverse Events Following LMA Removal
All patients received a predetermined Ce of remifentanil by TCI according to their group assignments from 10 minutes before the end of surgery to LMA removal. Adverse events such as coughing, airway obstruction, breath-holding, desaturation, nausea and vomiting were evaluated from the end of surgery until arrival in the post-anesthetic care unit.
Measured: from the end of surgery until arrival in the post-anesthetic care unit, an expected average of 15 minutes.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2012Jun 2013

First posted2 Aug 2013 (estimated)
Study startJul 2012
Primary completionJun 2013
Study completionJun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Respiratory ComplicationStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 128 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01915108
Sponsor's protocol ID: apsj1
Status last verified: Aug 2014
First submitted: 23 Jul 2013
Last updated: 25 Aug 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Respiratory Complication trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimal Effect-site Concentration of Remifentanil for Inhibiting Response to Laryngeal Mask Airway (LMA) Removal During Emergence From Sevoflurane-remifentanil Anesthesia
ClinicalTrials.gov ID: NCT01915108
Acronym / sponsor ID: apsj1
Conditions: Respiratory Complication
Study type: Interventional
Recruitment status: Completed
Enrolment: 128 participants (actual)
Lead sponsor: Sangjin ParkUniversity, hospital or other
Study start: Jul 2012
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 2 Aug 2013 (estimated)
Results: Posted 25 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study was designed to determine the optimal dose of remifentanil that can prevent the complications associated with the removal of LMA without delaying emergence.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 4

Arm	Type	Receives
group R0	No intervention	–remifentanil Ce of 0 ng/ml
group R0.5	Active comparator	Drug: Remifentanilremifentanil Ce of 0.5 ng/ml
group R1.0	Active comparator	Drug: Remifentanilremifentanil Ce of 1.0 ng/ml
group R1.5	Active comparator	Drug: Remifentanilremifentanil Ce of 1.5 ng/ml

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

American Society of Anesthesiologists physical status 1 or 2
undergoing lower extremity surgery under general anesthesia

Key exclusion criteria (5 listed)

suspected difficult airways
respiratory disease (chronic obstructive pulmonary disease, upper respiratory infection)
body mass index > 30 kg/m2
allergies to the study drugs
a history of gastric reflux

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
RemifentanilAlso: remifentanil (ultiva)All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml).	Drug	group R0.5, group R1.0, group R1.5

Primary outcome

Number of Patients With Adverse Events Following LMA Removal
Time frame: from the end of surgery until arrival in the post-anesthetic care unit, an expected average of 15 minutes.
All patients received a predetermined Ce of remifentanil by TCI according to their group assignments from 10 minutes before the end of surgery to LMA removal. Adverse events such as coughing, airway obstruction, breath-holding, desaturation, nausea and vomiting were evaluated from the end of surgery until arrival in the post-anesthetic care unit.

Results and safety

Results posted to the registry on 25 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group R0	32	30
Group R0.5	32	29
Group R1.0	32	31
Group R1.5	32	30

Primary outcome: Number of Patients With Adverse Events Following LMA Removal

Time frame: from the end of surgery until arrival in the post-anesthetic care unit, an expected average of 15 minutes.. Number. Unit: participants

Measure	Group R0 n = 30	Group R0.5 n = 29	Group R1.0 n = 31	Group R1.5 n = 30
Value	10	5	1	0

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group R0	1 of 30 (3.3%)	13 of 30 (43.3%)	Not reported
Group R1.5	1 of 30 (3.3%)	6 of 30 (20%)	Not reported
Group R0.5	0 of 29 (0%)	14 of 29 (48.3%)	Not reported
Group R1.0	0 of 31 (0%)	3 of 31 (9.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Respiratory Complication

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia

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.

sangjin park, M.D. principal investigator

Department of Anesthesiology and Pain Medicine, College of medicine, Yeungnam University, Daemyung-Dong, Nam-Gu, Daegu, Republic of Korea

Questions about this trial

What is this clinical trial studying?

A study testing Remifentanil in people with Respiratory Complication, run by Sangjin Park.

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 5 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 25 Aug 2014. 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. 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?

Yes. Results are posted in the registry (first posted 25 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Patients With Adverse Events Following LMA Removal (time frame: from the end of surgery until arrival in the post-anesthetic care unit, an expected average of 15 minutes.). 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 NCT01915108.

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 25 Aug 2014.