PainNCT01885364
Esmolol Pretreatment on Pain During Injection of Propofol
A study testing Normal saline, Esmolol and Remifentanil in people with Pain, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
Pain on injection of propofol is a common side effect. The present study was designed to investigate the effect of esmolol on pain on propofol injection and to compare it with remifentanil and placebo. Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Pain
- What is being tested?
- Normal saline, Esmolol and Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2015to Dec 2015
- 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 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients aged 19-60 years, American Society of Anesthesiologists (ASA) physical status I and II, scheduled for elective surgery under general anesthesia
Who cannot join
- Patients with cardiovascular, neurological or psychiatric disorder problem, patients who received the analgesic or sedative medications within the last 24 hours, and pregnancy were excluded
Trial locations and contacts
1 site in 1 country.
About this study
Pain on injection of propofol is a common side effect. The present study was designed to investigate the effect of esmolol on pain on propofol injection and to compare it with remifentanil and placebo.
Read the detailed description
In a double-blind, prospective trial, 120 patients scheduled to undergo elective surgery were randomized to receive normal saline (n=30), remifentanil 0.35 μg/kg (n=30), esmolol 0.5 mg/kg (n=30), or Esmolol 1mg/kg (n=30) as pretreatment. Thirty seconds after pretreatment, 25% of the total calculated dose of propofol (2 mg/kg) was administrated into a dorsal hand vein. Ten seconds after propofol had been given at the rate of 0.5 ml/sec pain was assessed on a four-point scale (0=none, 1 = mild, 2= moderate, 3= severe).
- Conditions
- Pain
- Being tested
- Normal saline, Esmolol, Remifentanil, propofol
- Keywords
- esmolol, 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.
Normal salineDrug
intravenous injection with normal saline before injection of propofol
EsmololDrug
Also called breviblock
intravenous injection with remifentanil 0.5 mg/kg before injection of propofol
RemifentanilDrug
Also called ultiva
intravenous injection with remifentanil 0.35 ug/kg before injection of propofol
propofolDrug
Also called diprivan
intravenous injection after pretreatment
| Study group | Role | What they receive |
|---|---|---|
| Placebo & propofol | Placebo comparator | Pretreatment with normal saline before injection of propofol Receives: Drug: Normal saline; Drug: propofol |
| esmolol 0.05 mg/kg & propofol | Experimental | Pretreatment with esmolol 0.05 mg/kg before injection of propofol Receives: Drug: Esmolol; Drug: propofol |
| esmolol 1 mg/kg & propofol | Experimental | Pretreatment with esmolol 1 mg/kg before injection of propofol Receives: Drug: Esmolol; Drug: propofol |
| remifentanil 0.35 ug/kg & propofol | Active comparator | Pretreatment with remifentanil 0.35 ug/kg before injection of propofol Receives: Drug: Remifentanil; Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain on injection of propofol
Thirty seconds after pretreatment, 25% of the total calculated dose of propofol (2 mg/kg) was administrated into a dorsal hand vein. Ten seconds after injection of propofol, pain was assessed on a four-point scale (0=none, 1 = mild, 2= moderate, 3= severe).
Measured: 10 seconds after injection of 25% of the total calculated dose of propofol (2 mg/kg)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startJun 2015
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Younghoon Jeon, Kyungpook National University Hospital
- Investigators
- Younghoon Jeon, Dr, Principal investigator, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885364
- Sponsor's protocol ID
- KNUH 2013-05-003-001
- Status last verified
- Feb 2016
- First submitted
- 18 Jun 2013
- Last updated
- 8 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esmolol Pretreatment on Pain During Injection of Propofol
- ClinicalTrials.gov ID
- NCT01885364
- Acronym / sponsor ID
- KNUH 2013-05-003-001
- Conditions
- Pain
- Keywords
- esmolol, pain, propofol, remifentanil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 25 Jun 2013 (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.
Pain on injection of propofol is a common side effect. The present study was designed to investigate the effect of esmolol on pain on propofol injection and to compare it with remifentanil and placebo.
Detailed description
In a double-blind, prospective trial, 120 patients scheduled to undergo elective surgery were randomized to receive normal saline (n=30), remifentanil 0.35 μg/kg (n=30), esmolol 0.5 mg/kg (n=30), or Esmolol 1mg/kg (n=30) as pretreatment. Thirty seconds after pretreatment, 25% of the total calculated dose of propofol (2 mg/kg) was administrated into a dorsal hand vein. Ten seconds after propofol had been given at the rate of 0.5 ml/sec pain was assessed on a four-point scale (0=none, 1 = mild, 2= moderate, 3= severe).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo & propofol | Placebo comparator | Drug: Normal saline, Drug: propofolPretreatment with normal saline before injection of propofol |
| esmolol 0.05 mg/kg & propofol | Experimental | Drug: Esmolol, Drug: propofolPretreatment with esmolol 0.05 mg/kg before injection of propofol |
| esmolol 1 mg/kg & propofol | Experimental | Drug: Esmolol, Drug: propofolPretreatment with esmolol 1 mg/kg before injection of propofol |
| remifentanil 0.35 ug/kg & propofol | Active comparator | Drug: Remifentanil, Drug: propofolPretreatment with remifentanil 0.35 ug/kg before injection of propofol |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients aged 19-60 years, American Society of Anesthesiologists (ASA) physical status I and II, scheduled for elective surgery under general anesthesia
Key exclusion criteria (1 listed)
- Patients with cardiovascular, neurological or psychiatric disorder problem, patients who received the analgesic or sedative medications within the last 24 hours, and pregnancy were excluded
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 |
|---|---|---|
| Normal salineintravenous injection with normal saline before injection of propofol | Drug | Placebo & propofol |
| EsmololAlso: breviblockintravenous injection with remifentanil 0.5 mg/kg before injection of propofol | Drug | esmolol 0.05 mg/kg & propofol, esmolol 1 mg/kg & propofol |
| RemifentanilAlso: ultivaintravenous injection with remifentanil 0.35 ug/kg before injection of propofol | Drug | remifentanil 0.35 ug/kg & propofol |
| propofolAlso: diprivanintravenous injection after pretreatment | Drug | Placebo & propofol, esmolol 0.05 mg/kg & propofol, esmolol 1 mg/kg & propofol, remifentanil 0.35 ug/kg & propofol |
Primary outcome
Pain on injection of propofol
Time frame: 10 seconds after injection of 25% of the total calculated dose of propofol (2 mg/kg)
Thirty seconds after pretreatment, 25% of the total calculated dose of propofol (2 mg/kg) was administrated into a dorsal hand vein. Ten seconds after injection of propofol, pain was assessed on a four-point scale (0=none, 1 = mild, 2= moderate, 3= severe).
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 8 Feb 2016.
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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.
Younghoon Jeon, Dr principal investigator
Kyungpook National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal saline, Esmolol and Remifentanil in people with Pain, run by Kyungpook National University Hospital 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 1 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 8 Feb 2016. 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?
Pain on injection of propofol (time frame: 10 seconds after injection of 25% of the total calculated dose of propofol (2 mg/kg)). 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 8 Feb 2016.