LidocainePhase 4anestheticsNCT05706987
Lidocaine Improves Satisfaction in Labiaplasty
A Phase 4 study testing Lidocaine and Normal saline in people with Lidocaine, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lidocaine
- What is being tested?
- Lidocaine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Feb 2023to 31 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 20-80 years old
- ASA score I-II
- receiving labiaplasty
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
About this study
Official title: Does Lidocaine Reduce Patient Moving Which Affect the Procedure Proceeding and Improves Surgeon Satisfaction in Labiaplasty
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.
Read the 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).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
continuous lidocaine infusion perioperatively
Normal salineDrug
normal saline
| Study group | Role | What they receive |
|---|---|---|
| lidocaine infusion | Experimental | intravenous lidocaine infusion 1.5mg/kg/hr (ideal body weight) during labiaplasty Receives: Drug: Lidocaine |
| normal saline infusion | Placebo comparator | equal volume of normal saline infusion during labiaplasty Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: about 1 hour (perioperatively)
Secondary outcomes (3)
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
Measured: up to 1 hour
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.
Measured: 1 hour after the surgery.
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.
Measured: immediately after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start15 Feb 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LidocaineStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhi-Fu Wu, MD, Study director, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706987
- Sponsor's protocol ID
- KMUHIRB-F(I)-20220178
- Acronym
- anesthetics
- Status last verified
- Nov 2022
- First submitted
- 30 Nov 2022
- Last updated
- 10 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Lidocaine Reduce Patient Moving Which Affect the Procedure Proceeding and Improves Surgeon Satisfaction in Labiaplasty
- ClinicalTrials.gov ID
- NCT05706987
- Acronym / sponsor ID
- anesthetics / KMUHIRB-F(I)-20220178
- Conditions
- Lidocaine
- Keywords
- Lidocaine, labiaplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 15 Feb 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lidocaine infusion | Experimental | Drug: Lidocaineintravenous lidocaine infusion 1.5mg/kg/hr (ideal body weight) during labiaplasty |
| normal saline infusion | Placebo comparator | Drug: Normal salineequal volume of normal saline infusion during labiaplasty |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 20-80 years old
- ASA score I-II
- receiving labiaplasty
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocainecontinuous lidocaine infusion perioperatively | Drug | lidocaine infusion |
| Normal salinenormal saline | Drug | normal saline infusion |
Primary outcome
the alteration of total usage of propofol and fentanyl
Time frame: 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
3 secondary outcomes
the alterations of total adverse events
Time frame: up to 1 hour
postoperative patient's satisfaction after anesthesia
Time frame: 1 hour after the surgery.
the surgeon's satisfaction after anesthesia service
Time frame: immediately after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhi-Fu Wu, MD study director
Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine and Normal saline in people with Lidocaine, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhi-Fu Wu, MD (88673121111 ext. 7035, aneswu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the alteration of total usage of propofol and fentanyl (time frame: about 1 hour (perioperatively)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.