An interventional study of Dexmedetomidine in Chest Wall Disorder, sponsored by Jung Min Koo. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-03-20.
Sponsored by Jung Min Koo · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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
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
Comparing effects of remifentanil versus dexmedetomidine
Also known as: Remifentanil
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Between 24~48 hours postoperatively.
Amount of postoperative intravenous patient controlled analgesics (PCA) used
Time frame: At 60 minutes after the end of surgery
Amount of fentanyl used postoperatively at the recovery unit
Amount in micgrograms per wegith in kilograms (migrogram/kilogram)
Time frame: At 60 minutes after the end of surgery
Time needed for postoperative rescue opioid analgesics
Time frame: At 60 minutes after the end of surgery
Amount of remifentanil or dexmedetomidine used intraoperatively
Time frame: Immediately at the end of the surgery
Intraoperative hemodynamic change: Systolic blood pressure
Time frame: 1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room
Intraoperative hemodynamic change: Diastolic blood pressure
Time frame: 1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room
Intraoperative hemodynamic change: mean blood pressure
Time frame: 1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room
Intraoperative hemodynamic change: heart rate
Time frame: 30 minutes after the induction of anesthesia
Intraoperative hemodynamic change: mean blood pressure
Time frame: At the end of the surgery, average of 90minutes after the induction of anesthesia
Intraoperative hemodynamic change: heart rate
Time frame: At the end of the surgery, average of 90minutes after the induction of anesthesia
Intraoperative hemodynamic change: Systolic blood pressure
Time frame: At the end of the surgery, average of 90minutes after the induction of anesthesia
Intraoperative hemodynamic change: Diastolic blood pressure
Time frame: At the end of the surgery, average of 90minutes after the induction of anesthesia
Rescue drugs (inotropics or vasopressors) used in order to correct hypotension or bradycardia
Time frame: Intraoperatively
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)
Time frame: Between 1~6 hours postoperatively
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)
Time frame: Between 12~24 hours postoperatively
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)
Time frame: Between 24~48 hours postoperatively
Plan to share: No
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Jung Min Koo