NCT04073758

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 29, 2019

Completed
4 days until next milestone

Study Start

First participant enrolled

September 2, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2021

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

March 20, 2020

Status Verified

March 1, 2020

Enrollment Period

1.5 years

First QC Date

August 20, 2019

Last Update Submit

March 18, 2020

Conditions

Chest Wall Disorder

Keywords

Pectus Excavatum

Outcome Measures

Primary Outcomes (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.

    Between 1~6 hours postoperatively.

  • 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.

    Between 6~12 hours postoperatively.

  • 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.

    Between 12~24 hours postoperatively.

  • 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.

    Between 24~48 hours postoperatively.

Secondary Outcomes (16)

  • Amount of postoperative intravenous patient controlled analgesics (PCA) used

    At 60 minutes after the end of surgery

  • Amount of fentanyl used postoperatively at the recovery unit

    At 60 minutes after the end of surgery

  • Time needed for postoperative rescue opioid analgesics

    At 60 minutes after the end of surgery

  • Amount of remifentanil or dexmedetomidine used intraoperatively

    Immediately at the end of the surgery

  • Intraoperative hemodynamic change: Systolic blood pressure

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

  • +11 more secondary outcomes

Study Arms (2)

Remifentanil group

SHAM COMPARATOR

In 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.

Drug: Dexmedetomidine

Dexmedetomidine group

ACTIVE COMPARATOR

In 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.

Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

Comparing effects of remifentanil versus dexmedetomidine

Also known as: Remifentanil
Dexmedetomidine groupRemifentanil group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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
  • Pregnant or breast feeding women
  • Hypersensitivity to the study drugs
  • Patients who do not agree to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jung Min Koo

Seoul, South Korea

Location

MeSH Terms

Conditions

Funnel Chest

Interventions

DexmedetomidineRemifentanil

Condition Hierarchy (Ancestors)

Bone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPropionatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPiperidines

Study Officials

  • Jung Min Koo, M.D

    Data recruitment

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 20, 2019

First Posted

August 29, 2019

Study Start

September 2, 2019

Primary Completion

February 21, 2021

Study Completion

February 28, 2021

Last Updated

March 20, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)