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Chest Wall DisorderARNRDNCT04073758

Comparison of Analgesic Requirements in Patients Receiving Nuss Operation Using 2 Different Anesthetic Adjuvants

A study testing Dexmedetomidine in people with Chest Wall Disorder, run by Jung Min Koo at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Nowadays, general anaesthesia is carried under "balanced anesthesia technique" in which many anesthetic adjuvants are used simultaneously, including opioid analgesics in order to reduce the amount of inhalation agents. The most popular adjuvants used are remifentanil, which is an opioid analgesic, and dexmedetomidine. Read more about this study

Who is it for?
Ages 20 to 60 years
Conditions the study is for
Chest Wall Disorder
What is being tested?
Dexmedetomidine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
62 participants
Where
1 siteSouth Korea
Study dates
2 Sep 2019to 28 Feb 2021
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 20 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Adults aged >20
  • Patients undergoing Nuss bar operation (pectus excavatum repair surgery)
  • American Society of Anesthesiologists classification I ~ III

Who cannot join

  • Drug abuse history
  • Chronic pain in need of continuous opioid analgesics administration
  • History of psychiatric diseases
  • Preoperative bradycardia (heart rate < 50/min) or arrythmia
  • Cardiac diseases other than diabetes or hypertension - coronary artery disease, ischemic heart disease
  • Moderate liver or kidney dysfunction
Show all 9Show fewer
  • Pregnant or breast feeding women
  • Hypersensitivity to the study drugs
  • Patients who do not agree to participate

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Jung Min Koo

    Seoul

Other trials in South Korea

About this study

Official title: Comparing Analgesic Requirements in Patients Receiving Nuss Operation Using Remifentanil or Dexmedetomidine as Anesthetic Adjuvants

Nowadays, general anaesthesia is carried under "balanced anesthesia technique" in which many anesthetic adjuvants are used simultaneously, including opioid analgesics in order to reduce the amount of inhalation agents. The most popular adjuvants used are remifentanil, which is an opioid analgesic, and dexmedetomidine. Both of these agents are short acting, can be infused with targeted concentrations, excreted shortly from the body with stable hemodynamics.

Remifentanil, when infused for more than 2 hours, causes hyperalgesia to increase the amount of pain postoperatively as well as the amount of opioid analgesics. However, dexmedetomidine does not cause hyperalgesia and is known to have an opioid -sparing effect. In our center.

In this study, we aim to compare the effects of remifentanil and dexmedetomidine on postoperative pain in patients undergoing Nuss procedure, which is a very painful operation on the chest wall.

Being tested
Dexmedetomidine
Keywords
Pectus Excavatum
Medical subject headings
Funnel Chest

What participants receive

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

  • DexmedetomidineDrug

    Also called Remifentanil

    Comparing effects of remifentanil versus dexmedetomidine

Study groups in NCT04073758
Study groupRoleWhat they receive
Remifentanil groupSham comparatorIn both interventional groups, Sevoflurane is used as an inhalational agent, in 0.5-1.5% age-adjusted Minimal Alveolar Concentration (MAC). As explained above, remifentanil is infused with Target Controlled Infusion pump, and concentration is adjusted so that Bispectral index (BIS) is maintained as 40-60, which means that the patients are maintained in general anesthesia. Remifentanil is usually infused with the effect site concentration of 2.0 to 6.0 ng/ml during general anesthesia. If bradycardia or hypotension develops due to remifentanil infusion, the infusion rate could be reduced, or inotropic, vasopressor, anticholinergic agents can be used (ephedrine, atropine, etc.) to correct the side effects of the drug, or the drug infusion can even be ceased. At the end of the surgery when skin closure starts, remifentanil infusion will be stopped.
Receives: Drug: Dexmedetomidine
Dexmedetomidine groupActive comparatorIn both interventional groups, Sevoflurane is used as an inhalational agent, in 0.5-1.5% age-adjusted MAC (Minimal Alveolar Concentration). As explained above, dexmedetomidine is infused with syringe pump, and concentration is adjusted so that Bispectral index (BIS) is maintained as 40-60, which means that the patients are maintained in general anesthesia. Dexmedetomidine is loaded for 10 minutes in 1mcg/kg, and then infusion rate is set between 0.4 to 0.6mcg/kg/hour for this study. If bradycardia or hypotension develops due to remifentanil infusion, the infusion rate could be reduced, or inotropic, vasopressor, anticholinergic agents can be used (ephedrine, atropine, etc.) to correct the side effects of the drug, or the drug infusion can even be ceased. At the end of the surgery when skin closure starts, dexmedetomidine infusion will be stopped.
Receives: Drug: Dexmedetomidine

What is being measured

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

  1. Visual Analogue Scale

    Pain scale ranges from 0 to 10. 0 means no pain at all, and 10 being the most severe pain anyone can imagine.

    Measured: Between 1~6 hours postoperatively.

  2. Visual Analogue Scale

    Pain scale ranges from 0 to 10. 0 means no pain at all, and 10 being the most severe pain anyone can imagine.

    Measured: Between 6~12 hours postoperatively.

  3. Visual Analogue Scale

    Pain scale ranges from 0 to 10. 0 means no pain at all, and 10 being the most severe pain anyone can imagine.

    Measured: Between 12~24 hours postoperatively.

  4. Visual Analogue Scale

    Pain scale ranges from 0 to 10. 0 means no pain at all, and 10 being the most severe pain anyone can imagine.

    Measured: Between 24~48 hours postoperatively.

Secondary outcomes (16)

  1. Amount of postoperative intravenous patient controlled analgesics (PCA) used

    Measured: At 60 minutes after the end of surgery

  2. Amount of fentanyl used postoperatively at the recovery unit

    Amount in micgrograms per wegith in kilograms (migrogram/kilogram)

    Measured: At 60 minutes after the end of surgery

  3. Time needed for postoperative rescue opioid analgesics

    Measured: At 60 minutes after the end of surgery

  4. Amount of remifentanil or dexmedetomidine used intraoperatively

    Measured: Immediately at the end of the surgery

  5. Intraoperative hemodynamic change: Systolic blood pressure

    Measured: 1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room

  6. Intraoperative hemodynamic change: Diastolic blood pressure

    Measured: 1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room

  7. Intraoperative hemodynamic change: mean blood pressure

    Measured: 1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room

  8. Intraoperative hemodynamic change: heart rate

    Measured: 30 minutes after the induction of anesthesia

  9. Intraoperative hemodynamic change: mean blood pressure

    Measured: At the end of the surgery, average of 90minutes after the induction of anesthesia

  10. Intraoperative hemodynamic change: heart rate

    Measured: At the end of the surgery, average of 90minutes after the induction of anesthesia

  11. Intraoperative hemodynamic change: Systolic blood pressure

    Measured: At the end of the surgery, average of 90minutes after the induction of anesthesia

  12. Intraoperative hemodynamic change: Diastolic blood pressure

    Measured: At the end of the surgery, average of 90minutes after the induction of anesthesia

  13. Rescue drugs (inotropics or vasopressors) used in order to correct hypotension or bradycardia

    Measured: Intraoperatively

  14. Postoperative complications

    Number of events that happened to the patient: e.g. Yes or No, and how many times. Nausea/vomiting, hypotension, respiratory depression, urinary retension, dizziness, transient cease in use of intravenous patient controlled analgesics (PCA)

    Measured: Between 1~6 hours postoperatively

  15. Postoperative complications

    Number of events that happened to the patient: e.g. Yes or No, and how many times. Nausea/vomiting, hypotension, respiratory depression, urinary retension, dizziness, transient cease in use of intravenous patient controlled analgesics (PCA)

    Measured: Between 12~24 hours postoperatively

  16. Postoperative complications

    Number of events that happened to the patient: e.g. Yes or No, and how many times. Nausea/vomiting, hypotension, respiratory depression, urinary retension, dizziness, transient cease in use of intravenous patient controlled analgesics (PCA)

    Measured: Between 24~48 hours postoperatively

Timeline

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

  1. First posted29 Aug 2019
  2. Study start2 Sep 2019
  3. Primary completion21 Feb 2021 (estimated)
  4. Study completion28 Feb 2021 (estimated)

Resources

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, Care provider, Investigator
Enrolment
62 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04073758
Sponsor's protocol ID
KC19MCSI0334
Acronym
ARNRD
Status last verified
Mar 2020
First submitted
20 Aug 2019
Last updated
20 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Dexmedetomidine in people with Chest Wall Disorder, run by Jung Min Koo 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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 20 Mar 2020. 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?

Results are not available in the source record.

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?

Visual Analogue Scale (time frame: Between 1~6 hours postoperatively.). The study lists 4 primary outcomes in all. 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 NCT04073758.

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 20 Mar 2020.

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