To Explore the Safety and Efficacy of Intravenous Infusion of Different Doses of Lidocaine in Patients

NCT05369650 | Unknown

• 1 other identifier: 2019-11
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (1)

• Immediate postoperative plasma lidocaine concentration

  Plasma lidocaine concentration is an important indicator for evaluating the safety of the drug during use

  Immediately after surgery

Secondary Outcomes (8)

• Plasma lidocaine concentration immediately after loading

  30 minutes before surgery

• 24-hour postoperative plasma lidocaine concentration

  24-hour postoperative

• The incidence of lidocaine toxicity within 72 hours after operation

  within 72 hours after operation

• 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

• The cumulative morphine consumption at 24, 48 and 72 hours postoperatively

  At the end of the surgery，24，48 and 72 hours after surgery

Study Arms (3)

Lidocaine 1 group

EXPERIMENTAL

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.

Drug: Lidocaine Hydrochloride, Injectable

Lidocaine 1.5 group

EXPERIMENTAL

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.

Drug: Lidocaine Hydrochloride, Injectable

Lidocaine 2 group

EXPERIMENTAL

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.

Drug: Lidocaine Hydrochloride, Injectable

Interventions

Lidocaine Hydrochloride, Injectable DRUG

The lidocaine group 1, 1.5 and 2 groups were injected with 1% lidocaine 1.5mg/kg (ideal body weight, 10min infusion) after anesthesia induction, respectively, and then continued to infuse 1% lidocaine. 1mg/kg.h, 1.5mg/kg.h, 2mg/kg.h (ideal body weight) until the end of the operation, and a patient-controlled intravenous analgesia (PCIA) pump containing lidocaine (PCIA) 0.3-1.5mg/kg after surgery. h to 72h after surgery.

Lidocaine 1 group; Lidocaine 1.5 group; Lidocaine 2 group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-70 years old
• American Society of Anesthesiologists(ASA) Ⅰ～III
• BMI≤30

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Lidocaine; Injections

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Chunling Jiang, PhD

  West China Hospital

  STUDY DIRECTOR

Central Study Contacts

Chunling Jiang, PhD

CONTACT

18980601096; jiang_chunling@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participants, the anesthesiologist, data collectors, the physicians performing the follow-up, and data analysts will be blinded to the group allocation. Blinding will maintain until the completion of the final analyses.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The experimental patients are randomly divided into three groups and received different doses of lidocaine and the control group received the same amount of saline.

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 11, 2022
• Study Start: July 27, 2019
• Primary Completion: May 27, 2022
• Study Completion: September 27, 2022
• Last Updated: May 11, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)