Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2026-01-02 @ 2:32 AM
Study NCT ID:
NCT05369650
Status:
UNKNOWN
Last Update Posted:
2022-05-11
First Post:
2022-05-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Explore the Safety and Efficacy of Intravenous Infusion of Different Doses of Lidocaine in Patients
Sponsor:
West China Hospital
Organization:
Study Overview
Official Title:
A Pilot Study on the Safety and Efficacy of Intravenous Infusion of Different Doses of Lidocaine for Postoperative Analgesia in Patients With Open Hepatectomy
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
RECRUITING
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:
None
Brief Summary:
All patients who met the inclusion criteria were randomly divided into four groups, 30 cases in each group, which were lidocaine group 1, lidocaine group 1.5, lidocaine group 2, and the placebo group In lidocaine group 1, lidocaine group 1.5, and lidocaine group 2, 1% lidocaine 1.5 mg/kg was intravenously infused with a micropump after anesthesia induction, and the infusion was completed within 10 minutes according to the ideal body weight, and then continued for 1% lidocaine was infused at 1 mg/kg.h, 1.5 mg/kg.h and 2 mg/kg.h respectively until the end of the operation. In the placebo group, the same volume of normal saline was used instead.
Detailed Description:
All patients who met the inclusion criteria were randomly divided into four groups, 30 cases in each group, which were lidocaine group 1, lidocaine group 1.5, lidocaine group 2, and the placebo group In lidocaine group 1, lidocaine group 1.5, and lidocaine group 2, 1% lidocaine 1.5 mg/kg was intravenously infused with a micropump after anesthesia induction, and the infusion was completed within 10 minutes according to the ideal body weight, and then continued for 1% lidocaine was infused at 1 mg/kg.h, 1.5 mg/kg.h and 2 mg/kg.h respectively until the end of the operation. In the placebo group, the same volume of normal saline was used instead.Postoperative pain management during the first 72 postoperative hours will involve the use of a PCIA device, which will contain lidocaine 30mg/kg, sufentanil 2 μg/kg, granisetron 12 mg diluted to 200 mL in 0.9 % normal saline. In the placebo group, the same volume of normal saline will be administered during anesthesia. The postoperative PCIA device will contain sufentanil 2 μg/kg, granisetron 12 mg diluted to 200 mL in 0.9% normal saline solution with a total volume of 200 ml. All the background infusions of PCIA will set at 2 ml/h, the bolus volume of each PCIA press is 2 ml and the lockout interval is 15 min.
Study Oversight
Has Oversight DMC:
False
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?: