Drug UsagePhase 4NCT03330782
Remifentanil for Preventing Propofol Injection Pain in Elderly Patients
A Phase 4 study testing Remifentanil in people with Drug Usage, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
Elderly patients show different pharmacokinetic and pharmacodynamic variables and usually need smaller doses of anesthetic drugs than younger patients. The purpose of this study was to investigate the optimal effect-site concentration of remifentanil for preventing injection pain during propofol induction in elderly… Read more about this study
- Who is it for?
- Ages 19 to 80 years, men only
- Conditions the study is for
- Drug Usage
- What is being tested?
- Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Nov 2017to 15 Jun 2018
- Phase
- Phase 4
- 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 19 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I or II undergoing general anesthesia
Who cannot join
- neurologic disorder
- psychologic disorder
- vascular disorder
- patients with chronic pain
- difficulty in vascular access
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect-site Concentration of Remifentanil for Preventing Propofol Injection Pain in Elderly Patients: A Comparison With Adult Patients
Elderly patients show different pharmacokinetic and pharmacodynamic variables and usually need smaller doses of anesthetic drugs than younger patients. The purpose of this study was to investigate the optimal effect-site concentration of remifentanil for preventing injection pain during propofol induction in elderly patients by the Dixon's up-and-down method.
- Conditions
- Drug Usage
- Being tested
- Remifentanil
- Keywords
- pain, propofol, remifentanil
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
Also called Ultiva
Remifentanil was infused at predetermined effect-site concentration prior to propofol infusion (initial concentration: 3.0 ng/ml) in elderly patients (65-80 years)
RemifentanilDrug
Also called Ultiva
Remifentanil was infused at predetermined effect-site concentration prior to propofol infusion (initial concentration: 3.0 ng/ml) in adult patients (20-60 years)
| Study group | Role | What they receive |
|---|---|---|
| Elderly | Experimental | Remifentanil was infused at predetermined effect-site concentration before propofol infusion in elderly patients. Receives: Drug: Remifentanil |
| Adult | Active comparator | Remifentanil was infused at predetermined effect-site concentration before propofol infusion in adult patients. Receives: Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of propofol injection pain-4 point scale
0 = no pain (negative response to questioning),
- = mild pain (pain reported only in response to questioning without any behavioral signs),
- = moderate pain (pain reported in response to questioning and accompanied by a behavioral signs or pain reported spontane¬ously without questioning),
- = severe pain (vocal response accompanied by facial grimacing, arm withdrawal, or tears)
Measured: during 3 min after remifentanil and propofol infusion to reach the equilibrium of plasma and effect-site concentration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start16 Nov 2017
- Primary completion15 Jun 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug UsageStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jong Yeop Kim, Ajou University School of Medicine
- Investigators
- Jong Yeop Kim, Principal investigator, Ajou University Hospital, Suwon, Gyeongki-do, South Korea, 443-721
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330782
- Sponsor's protocol ID
- AJIRB-MED-OBS-17-197
- Status last verified
- Jul 2019
- First submitted
- 30 Oct 2017
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect-site Concentration of Remifentanil for Preventing Propofol Injection Pain in Elderly Patients: A Comparison With Adult Patients
- ClinicalTrials.gov ID
- NCT03330782
- Acronym / sponsor ID
- AJIRB-MED-OBS-17-197
- Conditions
- Drug Usage
- Keywords
- pain, propofol, remifentanil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 6 Nov 2017 (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.
Elderly patients show different pharmacokinetic and pharmacodynamic variables and usually need smaller doses of anesthetic drugs than younger patients. The purpose of this study was to investigate the optimal effect-site concentration of remifentanil for preventing injection pain during propofol induction in elderly patients by the Dixon's up-and-down method.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elderly | Experimental | Drug: RemifentanilRemifentanil was infused at predetermined effect-site concentration before propofol infusion in elderly patients. |
| Adult | Active comparator | Drug: RemifentanilRemifentanil was infused at predetermined effect-site concentration before propofol infusion in adult patients. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA physical status I or II undergoing general anesthesia
Key exclusion criteria (5 listed)
- neurologic disorder
- psychologic disorder
- vascular disorder
- patients with chronic pain
- difficulty in vascular access
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: UltivaRemifentanil was infused at predetermined effect-site concentration prior to propofol infusion (initial concentration: 3.0 ng/ml) in elderly patients (65-80 years) | Drug | Elderly |
| RemifentanilAlso: UltivaRemifentanil was infused at predetermined effect-site concentration prior to propofol infusion (initial concentration: 3.0 ng/ml) in adult patients (20-60 years) | Drug | Adult |
Primary outcome
Severity of propofol injection pain-4 point scale
Time frame: during 3 min after remifentanil and propofol infusion to reach the equilibrium of plasma and effect-site concentration
0 = no pain (negative response to questioning), 1. = mild pain (pain reported only in response to questioning without any behavioral signs), 2. = moderate pain (pain reported in response to questioning and accompanied by a behavioral signs or pain reported spontane¬ously without questioning), 3. = severe pain (vocal response accompanied by facial grimacing, arm withdrawal, or tears)
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 Jul 2019.
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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.
Jong Yeop Kim principal investigator
Ajou University Hospital, Suwon, Gyeongki-do, South Korea, 443-721
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remifentanil in people with Drug Usage, run by Ajou University School of Medicine 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 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 5 Jul 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Severity of propofol injection pain-4 point scale (time frame: during 3 min after remifentanil and propofol infusion to reach the equilibrium of plasma and effect-site concentration). 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 Jul 2019.