Clinical trial NCT04073758: Comparison of Analgesic Requirements in Patients Receiving Nuss Operation Using 2 Different Anesthetic Adjuvants
Official title: Comparing Analgesic Requirements in Patients Receiving Nuss Operation Using Remifentanil or Dexmedetomidine as Anesthetic Adjuvants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chest Wall Disorder
Keywords: Pectus Excavatum
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2019-08-29
Enrollment: 62
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: Between 1~6 hours postoperatively.
measure: Visual Analogue Scale
timeFrame: Between 6~12 hours postoperatively.
measure: Visual Analogue Scale
timeFrame: Between 12~24 hours postoperatively.
measure: Visual Analogue Scale
timeFrame: Between 24~48 hours postoperatively.
Secondary outcomes:
measure: Amount of postoperative intravenous patient controlled analgesics (PCA) used
timeFrame: At 60 minutes after the end of surgery
measure: Amount of fentanyl used postoperatively at the recovery unit
timeFrame: At 60 minutes after the end of surgery
measure: Time needed for postoperative rescue opioid analgesics
timeFrame: At 60 minutes after the end of surgery
measure: Amount of remifentanil or dexmedetomidine used intraoperatively
timeFrame: Immediately at the end of the surgery
measure: Intraoperative hemodynamic change: Systolic blood pressure
timeFrame: 1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room
measure: Intraoperative hemodynamic change: Diastolic blood pressure
timeFrame: 1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room
measure: Intraoperative hemodynamic change: mean blood pressure
timeFrame: 1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room
measure: Intraoperative hemodynamic change: heart rate
timeFrame: 30 minutes after the induction of anesthesia
measure: Intraoperative hemodynamic change: mean blood pressure
timeFrame: At the end of the surgery, average of 90minutes after the induction of anesthesia
measure: Intraoperative hemodynamic change: heart rate
timeFrame: At the end of the surgery, average of 90minutes after the induction of anesthesia
measure: Intraoperative hemodynamic change: Systolic blood pressure
timeFrame: At the end of the surgery, average of 90minutes after the induction of anesthesia
measure: Intraoperative hemodynamic change: Diastolic blood pressure
timeFrame: At the end of the surgery, average of 90minutes after the induction of anesthesia
measure: Rescue drugs (inotropics or vasopressors) used in order to correct hypotension or bradycardia
timeFrame: Intraoperatively
measure: Postoperative complications
timeFrame: Between 1~6 hours postoperatively
measure: Postoperative complications
timeFrame: Between 12~24 hours postoperatively
measure: Postoperative complications
timeFrame: Between 24~48 hours postoperatively
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jung Min Koo
Study officials:
affiliation: Data recruitment
name: Jung Min Koo, M.D
role: PRINCIPAL_INVESTIGATOR
References: