Lidocaine Improves Satisfaction in Labiaplasty

Lidocaine Clinical Trial

— anesthetics  

Official title:

Does Lidocaine Reduce Patient Moving Which Affect the Procedure Proceeding and Improves Surgeon Satisfaction in Labiaplasty

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05706987
• Other study ID #: KMUHIRB-F(I)-20220178
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: February 15, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2022
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: Zhi-Fu Wu, MD
• Phone: 88673121111
• Email: aneswu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lidocaine

Intervention

Drug:
• Lidocaine
continuous lidocaine infusion perioperatively
• Normal saline
normal saline

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the alteration of total usage of propofol and fentanyl	Comparing the treatment group with the control group the total infusion dose of propofol sedation and bolus intravenous fentanyl use perioperatively	about 1 hour (perioperatively)
Secondary	the alterations of total adverse events	Comparing the total adverse events caused by propofol sedation or fentanyl analgesics such as apnea or hypoxemia between the treatment and the control group	up to 1 hour
Secondary	postoperative patient's satisfaction after anesthesia	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.	1 hour after the surgery.
Secondary	the surgeon's satisfaction after anesthesia service	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.	immediately after the surgery