None listed
Conditions
Interventions
Drug : Upon entering the operating room, the patient is identified and vital signs are checked
then, the assigned study drug is administered intravenously. For the Unafra group, a loading dose consisting of 400 mL of normal saline (N/S) mixed with 100 mL (1000 mg) of Unafra is administered at a
Sponsors
Chonnam National University Hwasun Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with an American Society of Anesthesiologists Physical Status (ASA PS) classification of 1–3 2. Patients aged 20 to 79 scheduled for elective colorectal surgery under general anesthesia 3. Patients who have voluntarily provided written consent to participate in this clinical study
Exclusion criteria
Exclusion criteria: 1. Patients with hypersensitivity to Unafra 2. Patients with unstable angina or congestive heart failure; patients with ECG readings showing QRS > 200 msec, or QTcF > 450 msec (males) or QTcF > 470 msec (females) 3. Patients with moderate to severe renal impairment 4. Patients with moderate to severe hepatic impairment 5. Pregnant or lactating women 6. Patients receiving drugs known to prolong PR or QRS intervals 7. Patients receiving potent CYP3A4 inhibitors 8. Patients with physical disabilities or illiteracy 9. Patients otherwise deemed unsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Korean version of Quality of Recovery-40 score | — |
Secondary
| Measure | Time frame |
|---|---|
| Korean version of Quality of Recovery-40 score;Dose of Remifentanil used during surgery;Numeric Rating Scale;Postoperative Nausea and Vomiting score ; Patient-controlled analgesia drug usage in the last 24 hours | — |
Countries
Korea, Republic of
Contacts
Public ContactKYEONG CHEOL JANG
Chonnam National University Hwasun Hospital
Outcome results
None listed