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

Chest Wall Disorder Clinical Trial

— ARNRD  

Official title:

Comparing Analgesic Requirements in Patients Receiving Nuss Operation Using Remifentanil or Dexmedetomidine as Anesthetic Adjuvants

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04073758
• Other study ID #: KC19MCSI0334
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 2, 2019
• Est. completion date: February 28, 2021

Study information

• Verified date: March 2020
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 62
• Est. completion date: February 28, 2021
• Est. primary completion date: February 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Chest Wall Disorder

Intervention

Drug:
• Dexmedetomidine
Comparing effects of remifentanil versus dexmedetomidine

Locations

Country	Name	City	State
Korea, Republic of	Jung Min Koo	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Jung Min Koo

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	Amount of postoperative intravenous patient controlled analgesics (PCA) used		At 60 minutes after the end of surgery
Secondary	Amount of fentanyl used postoperatively at the recovery unit	Amount in micgrograms per wegith in kilograms (migrogram/kilogram)	At 60 minutes after the end of surgery
Secondary	Time needed for postoperative rescue opioid analgesics		At 60 minutes after the end of surgery
Secondary	Amount of remifentanil or dexmedetomidine used intraoperatively		Immediately at the end of the surgery
Secondary	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
Secondary	Intraoperative hemodynamic change: Diastolic blood pressure		1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room
Secondary	Intraoperative hemodynamic change: mean blood pressure		1 minute after monitoring (of blood pressure, heart rate, pulse oxymeter and electrocardiogram) starts, when the patient arrives at the operating room
Secondary	Intraoperative hemodynamic change: heart rate		30 minutes after the induction of anesthesia
Secondary	Intraoperative hemodynamic change: mean blood pressure		At the end of the surgery, average of 90minutes after the induction of anesthesia
Secondary	Intraoperative hemodynamic change: heart rate		At the end of the surgery, average of 90minutes after the induction of anesthesia
Secondary	Intraoperative hemodynamic change: Systolic blood pressure		At the end of the surgery, average of 90minutes after the induction of anesthesia
Secondary	Intraoperative hemodynamic change: Diastolic blood pressure		At the end of the surgery, average of 90minutes after the induction of anesthesia
Secondary	Rescue drugs (inotropics or vasopressors) used in order to correct hypotension or bradycardia		Intraoperatively
Secondary	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)	Between 1~6 hours postoperatively
Secondary	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)	Between 12~24 hours postoperatively
Secondary	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)	Between 24~48 hours postoperatively