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

Not Applicable

• Conditions: Chest Wall Disorder
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT04073758
• Lead Sponsor: Jung Min Koo

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-20
• Study First Submitted QC: 2019-08-27
• Study First Posted: 2019-08-29
• Study Start: 2019-09-02
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-18
• Last Update Posted: 2020-03-20
• Primary Completion: 2021-02-21
• Study Completion: 2021-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine group	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.
Remifentanil group	Dexmedetomidine	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.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale	Between 24~48 hours postoperatively.	Pain scale ranges from 0 to 10. 0 means no pain at all, and 10 being the most severe pain anyone can imagine.

Secondary Outcome Measures

Name	Time	Method
Amount of fentanyl used postoperatively at the recovery unit	At 60 minutes after the end of surgery	Amount in micgrograms per wegith in kilograms (migrogram/kilogram)
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	At the end of the surgery, average of 90minutes after the induction of anesthesia
Intraoperative hemodynamic change: Diastolic blood pressure	At the end of the surgery, average of 90minutes after the induction of anesthesia
Intraoperative hemodynamic change: mean blood pressure	At the end of the surgery, average of 90minutes after the induction of anesthesia
Amount of postoperative intravenous patient controlled analgesics (PCA) used	At 60 minutes after the end of surgery
Intraoperative hemodynamic change: heart rate	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	Intraoperatively
Postoperative complications	Between 24~48 hours postoperatively	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)

Trial Locations

Locations (1)

Jung Min Koo; 🇰🇷 Seoul, Korea, Republic of