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

Jung Min Koo

Status: Unknown

Conditions: Chest Wall Disorder

Treatments: Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT04073758

KC19MCSI0334

Details and patient eligibility

About

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.

Enrollment: 62 estimated patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

62 participants in 2 patient groups

Remifentanil group

Sham Comparator group

Description:

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.

Treatment:

Drug: Dexmedetomidine

Dexmedetomidine group

Active Comparator group

Description:

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.

Treatment:

Drug: Dexmedetomidine