1.Written informed consent must be obtained before any study specific procedures are
undertaken.Qualified participants were identified at the pre-anesthesia evaluation clinic or
ward.
2.80 patients with American Society of Anesthesiologists (ASA) score of I-II in our medical
center scheduled to undergo elective surgery for hypertrophy of labia minor with MAC.
Patients were randomized 1:1 into the Group 1 (normal saline) or Group 2 (lidocaine 1.5
mg/kg/hr, ideal body weight) by using a table of random, computer-generated digits in sealed
and numbered envelopes by an anesthesiologist. All surgical procedure was performed by the
same surgeon and the anesthetic data was recorded by a nurse anesthetist. All patients were
fasted overnight before the procedure, and no medications were allowed before induction of
anesthesia. Standard monitoring, such as non-invasive arterial blood pressure,
electrocardiography (lead II), pulse oximetry, end-tidal carbon dioxide pressure (EtCO2) was
applied for each patient. Participants were pre-oxygenated and adequately maintained with
100% oxygen at 3 L/min via a nasal cannula during the entire procedure. During anesthesia
induction, all patients received intravenous fentanyl 0.1 mcg/kg, continuous infusion of
propofol with target-controlled infusion (TCI; Fresenius Orchestra Primea; Fresenius Kabi AG,
Bad Homburg, Germany) with the Ce of 4.0 mcg/mL and parecoxib. In addition, continuous
infusion of equal volume normal saline and lidocaine 1.5 mg/kg/hr (ideal body weight) in
group I and 2, respectively. In all patients, maintenance of the Ce of propofol was adjusted
upward or downward by 0.5 mcg/mL to keep patient adequate sedation with acceptable pain
(remaining moveless). If upward 2 times of propofol and the patient still move which affect
the surgical procedure, fentanyl 0.05 mcg/kg was prescribed, and mean arterial pressure (MAP)
and heart rate (HR) within baseline levels. As soon as the last suture, the propofol and
lidocaine were discontinued. After the procedure, all patients were sent to the PACU for
further care under clear consciousness.
Phase:
Phase 4
Details
Lead Sponsor:
Kaohsiung Medical University Chung-Ho Memorial Hospital