Lidocaine Improves Satisfaction in Labiaplasty

NCT05706987 | Unknown Phase 4

• 1 other identifier: KMUHIRB-F(I)-20220178
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Lidocaine

Keywords

Lidocaine; labiaplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• the alterations of total adverse events

  up to 1 hour

• postoperative patient's satisfaction after anesthesia

  1 hour after the surgery.

• the surgeon's satisfaction after anesthesia service

  immediately after the surgery

Study Arms (2)

lidocaine infusion

EXPERIMENTAL

intravenous lidocaine infusion 1.5mg/kg/hr (ideal body weight) during labiaplasty

Drug: Lidocaine

normal saline infusion

PLACEBO COMPARATOR

equal volume of normal saline infusion during labiaplasty

Drug: Normal saline

Interventions

Lidocaine DRUG

continuous lidocaine infusion perioperatively

lidocaine infusion

Normal saline DRUG

normal saline

normal saline infusion

Eligibility Criteria

• Age: 20 Years - 80 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 20-80 years old
• ASA score I-II
• receiving labiaplasty

You may not qualify if:

• age \< 20 years or older than 80 years
• ASA score more than II
• height \<152 and \>213 cm
• body mass index \> 35 kg/m2
• allergy to midazolam and lidocaine
• chronic use of opioid drugs

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Study Sites (1)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Location

MeSH Terms

Interventions

Lidocaine; Saline Solution

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Zhi-Fu Wu, MD

  Kaohsiung Medical University

  STUDY DIRECTOR

Central Study Contacts

Zhi-Fu Wu, MD

CONTACT

88673121111; aneswu@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: January 31, 2023
• Study Start: February 15, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 10, 2023

Record last verified: 2022-11

Locations

TW (1)