Ignite Creation Date:
2024-05-06 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05706987
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-02-10
First Post:
2022-11-30
Brief Title:
Lidocaine Improves Satisfaction in Labiaplasty
Sponsor:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Organization:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study Overview
Official Title:
Does Lidocaine Reduce Patient Moving Which Affect the Procedure Proceeding and Improves Surgeon Satisfaction in Labiaplasty
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
anesthetics
Brief Summary:
1Written informed consent must be obtained before any study specific procedures are undertakenQualified participants were identified at the pre-anesthesia evaluation clinic or ward
280 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 11 into the Group 1 normal saline or Group 2 lidocaine 15 mgkghr 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 Lmin via a nasal cannula during the entire procedure During anesthesia induction all patients received intravenous fentanyl 05-1 mcgkg continuous infusion of propofol with target-controlled infusion TCI Fresenius Orchestra Primea Fresenius Kabi AG Bad Homburg Germany with the Ce of 40 mcgmL and parecoxib In addition continuous infusion of equal volume normal saline and lidocaine 15 mgkghr ideal body weight in group I and 2 respectively In all patients maintenance of the Ce of propofol was adjusted upward or downward by 05 mcgmL 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 05 mcgkg 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
280 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 11 into the Group 1 normal saline or Group 2 lidocaine 15 mgkghr 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 Lmin via a nasal cannula during the entire procedure During anesthesia induction all patients received intravenous fentanyl 05-1 mcgkg continuous infusion of propofol with target-controlled infusion TCI Fresenius Orchestra Primea Fresenius Kabi AG Bad Homburg Germany with the Ce of 40 mcgmL and parecoxib In addition continuous infusion of equal volume normal saline and lidocaine 15 mgkghr ideal body weight in group I and 2 respectively In all patients maintenance of the Ce of propofol was adjusted upward or downward by 05 mcgmL 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 05 mcgkg 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 OAAS 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 surgeons satisfaction At PACU patients were monitored for HR MBP SpO2 RR NRS RASS length of stay PONV and patient satisfaction scoring 1-5
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None