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Not Yet Recruiting NCT05706987

Lidocaine Improves Satisfaction in Labiaplasty

Conditions: Lidocaine

Sex: Female
Ages: 20 Years – 80 Years
Healthy volunteers: 1
Phase: PHASE4
Enrollment: 80
Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Location: Taiwan

Summary

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 0.5-1 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 0.5 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.

Eligibility Criteria

Inclusion Criteria:Age between 20-80 years oldASA score I-IIreceiving labiaplastyExclusion Criteria:age < 20 years or older than 80 yearsASA score more than IIheight <152 and >213 cmbody mass index > 35 kg/m2allergy to midazolam and lidocainechronic use of opioid drugs

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05706987). StuddyBuddy aggregates publicly available trial information.