Lidocaine Improves Satisfaction in Labiaplasty

Phase 4

Not yet recruiting

• Conditions: Lidocaine
• Interventions: Drug: Normal saline; Drug: Lidocaine

• Registration Number: NCT05706987
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief 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.

Detailed Description

Patients were monitored for MBP, HR, peripheral oxygen saturation (SpO2), respiratory rate (RR), EtCO2, Ce of propofol, BIS values, OAA/S at the T1: before anesthesia induction, T2: time of the skin incision, T3: 15 minutes after the skin incision, T4: 30 minutes after the skin incision, T5: 45 minutes after the skin incision, T6: time of the beginning skin suture, and T7: time of the end of procedure. Collected data also include the time that the surgery ended, the total usage of propofol and fentanyl, the frequency to adjustment of TCI, times of patient move affect the procedure, and the surgeon's satisfaction. At PACU, patients were monitored for HR, MBP, SpO2, RR, NRS, RASS, length of stay, PONV and patient satisfaction (scoring 1-5).

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-30
• Study First Submitted QC: 2023-01-29
• Study First Posted: 2023-01-31
• Last Update Submitted: 2023-02-08
• Last Update Posted: 2023-02-10
• Study Start: 2023-02-15
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

1. Age between 20-80 years old
2. ASA score I-II
3. receiving labiaplasty

Exclusion Criteria

1. age < 20 years or older than 80 years
2. ASA score more than II
3. height <152 and >213 cm
4. body mass index > 35 kg/m2
5. allergy to midazolam and lidocaine
6. chronic use of opioid drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal saline infusion	Normal saline	equal volume of normal saline infusion during labiaplasty
lidocaine infusion	Lidocaine	intravenous lidocaine infusion 1.5mg/kg/hr (ideal body weight) during labiaplasty

Primary Outcome Measures

Name	Time	Method
the alteration of total usage of propofol and fentanyl	about 1 hour (perioperatively)	Comparing the treatment group with the control group the total infusion dose of propofol sedation and bolus intravenous fentanyl use perioperatively

Secondary Outcome Measures

Name	Time	Method
the alterations of total adverse events	up to 1 hour	Comparing the total adverse events caused by propofol sedation or fentanyl analgesics such as apnea or hypoxemia between the treatment and the control group
postoperative patient's satisfaction after anesthesia	1 hour after the surgery.	Comparing the patient's satisfaction after anesthesia between the treatment group and the control group. The patient would be asked to score her satisfaction from 1-5, 1 as very dissatisfied, 2 as dissatisfied, 3 as neutral, 4 as satisfied and 5 as very satisfied.
the surgeon's satisfaction after anesthesia service	immediately after the surgery	Comparing the surgeon's satisfaction after anesthesia service between the treatment group and the control group. The surgeon's satisfaction after anesthesia service would be calculated by scoring 1-5, 1 as very dissatisfied, 2 as dissatisfied, 3 as neutral, 4 as satisfied and 5 as very satisfied.

Trial Locations

Locations (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan