To Explore the Safety and Efficacy of Intravenous Infusion of Different Doses of Lidocaine in Patients
- Registration Number
- NCT05369650
- Lead Sponsor
- West China Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- Age: 18-70 years old
- American Society of Anesthesiologists(ASA) Ⅰ～III
- BMI≤30
- Intended for open liver resection Exclusion criteria：1. Long-term opioid users 2. Patients with contraindications or allergies to any drugs (lidocaine, etc.) used in this study 3. Patients with severe hepatic insufficiency before surgery (defined as total bilirubin>1.46mg/dl), renal insufficiency (glomerular filtration rate <30ml/min/1.73m2 or end-stage renal disease) 4. Associated with severe heart disease (second or third degree atrioventricular block); severe heart failure (ejection fraction <50%); sinus bradycardia; patient 6. Patients who participated in other clinical trials within 3 months before enrollment in the study.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lidocaine 1.5 group Lidocaine Hydrochloride, Injectable After induction of anesthesia, 1% lidocaine 1.5mg/kg (ideal body weight, 10min pumped) was injected intravenously with a micro pump, and then 1% lidocaine 1.5mg/kg.h (ideal body weight) was continuously pumped until the end of the operation , connected to patient-controlled intravenous analgesia (PCIA) pump containing lidocaine 0.3-1.5mg/kg.h after operation to 72h after operation. Lidocaine 2 group Lidocaine Hydrochloride, Injectable After induction of anesthesia, 1% lidocaine 1.5mg/kg (ideal body weight, 10min pumped) was injected intravenously with a micro pump, and then 1% lidocaine 2mg/kg.h (ideal body weight) was continuously pumped until the end of the operation , connected to patient-controlled intravenous analgesia (PCIA) pump containing lidocaine 0.3-1.5mg/kg.h after operation to 72h after operation. Lidocaine 1 group Lidocaine Hydrochloride, Injectable After induction of anesthesia, 1% lidocaine 1.5mg/kg (ideal body weight, 10min pumped) was injected intravenously with a micro pump, and then 1% lidocaine 1mg/kg.h (ideal body weight) was continuously pumped until the end of the operation , connected to patient-controlled intravenous analgesia (PCIA) pump containing lidocaine 0.3-1.5mg/kg.h after operation to 72h after operation.
- Primary Outcome Measures
Name Time Method Immediate postoperative plasma lidocaine concentration Immediately after surgery Plasma lidocaine concentration is an important indicator for evaluating the safety of the drug during use
- Secondary Outcome Measures
Name Time Method Plasma lidocaine concentration immediately after loading 30 minutes before surgery Plasma lidocaine concentration is an important indicator for evaluating the safety of the drug during use
24-hour postoperative plasma lidocaine concentration 24-hour postoperative Plasma lidocaine concentration is an important indicator for evaluating the safety of the drug during use
The incidence of moderate to severe pain at 24、48 and 72 hours after surgery at rest and during movement; 24，48 and 72 hours after surgery he pain is evaluated using numerical rating scale（NRS). NRS scores range from 0 to 10 points, with 0 points representing no pain, 1-3 points representing mild pain, 4-6 points representing moderate pain, 7-9 points representing severe pain and 10 points representing the strongest pain.
Bowel function recovery At 3 days after surgery defined as the time to first defecation or time to first flatus
The incidence of lidocaine toxicity within 72 hours after operation within 72 hours after operation Lidocaine toxicity mainly includes neurological manifestations such as dizziness, tinnitus, convulsions, cardiac manifestations such as bradycardia, new severe atrioventricular block and so on.
The cumulative morphine consumption at 24, 48 and 72 hours postoperatively At the end of the surgery，24，48 and 72 hours after surgery intra-operative and postoperative opioid use is reported as morphine milligram
Postoperative hospital stay up to 30 days The days of hospital stay after the operation were calculated from the first day after the operation to the days of discharge.
Patient satisfaction scores 72 hours after surgery (satisfaction scores regarding pain control and the overall recovery process were obtained at 72 hours after surgery, using a 11-point Likert scale, with 0 indicating "very dissatisfied"and10 indicating "very satisfied"
Trial Locations
- Locations (1)
West China Hospital
🇨🇳Chengdu, Sichuan, China