Effects of Intravenous Lidocaine on ED50, ED95 and NTI Values of Propofol Induced Unconsciousness

The effect of intravenous lidocaine on ED50 and ED95 of propofol, which causes unconsciousness, is unclear. In addition, it is not clear whether the depth of anesthesia induced by propofol changes when lidocaine is used in combination. Therefore, the purpose of this study was to study the effects of intravenous lidocaine on ED50, ED95 and NTI values of propofol induced unconsciousness .

Study Overview

• Status: Not yet recruiting
• Conditions: General Anesthesia
• Intervention / Treatment: Drug: Lidocaine; Drug: Normal saline

Detailed Description

Intravenous lidocaine has many advantages in perioperative period, in addition to reducing the amount of opioids and propofol, thus reducing the incidence of adverse reactions caused by them, it also has the effect on organ protection, can shorten the length of hospital stay, and promote postoperative recovery. The effect of intravenous lidocaine on ED50 and ED95 of propofol, which causes unconsciousness, is unclear. In addition, it is not clear whether the depth of anesthesia induced by propofol changes when lidocaine is used in combination. Therefore, the purpose of this study was to study the effects of intravenous lidocaine on ED50, ED95 and NTI values of propofol induced unconsciousness .

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: GuiMei Ji, master; Phone Number: 13619587243; Email: 1987780277@qq.com

Study Locations

• China
  • Ningxia
    • Yinchuan, Ningxia, China, 750004
      • General Hospital of Ningxia Medical University
      • Contact: Hanxiang Ma, master; Phone Number: +86-13519591508; Email: mahanxiang@hotmail.com
    • Yinchuan, Ningxia, China, 756000
      • GuiMei Ji
      • Contact: Hanxiang Ma, master; Phone Number: 13519591508

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. The informed consent is signed
2. Aged 18 to 65 years old
3. ASA is rated from I to II
4. Body mass index ranged from 18.5 to 24.9 kg/m2

Exclusion Criteria:

1. Unwilling to sign informed consent or refuse to participate in the study
2. Patients with serious arrhythmia and organic heart disease before surgery
3. Sedative and analgesic drugs were taken within 1 week before surgery
4. Lidocaine allergy
5. Patients with mental and neurological diseases
6. Patients with difficult airway
7. People with hearing impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LP group; The experimental group received 1.5 mg/kg lidocaine intravenously,after 90s, the corresponding dose of propofol was injected intravenously at 30mg/kg/h, and to observe Whether consciousness disappears or not，recording NTI values, heart rate, oxygen saturation, mean arterial pressure and drug side effects in the baseline state, 90s after lidocaine administration, 60s and 120s after propofol administration	Drug: Lidocaine; The experimental group was injected with lidocaine 1.5mg/kg, and propofol was pumped intravenously at 90s after lidocaine injection.The dose of propofol was further set according to groups. The heart rate, mean arterial pressure, pulse oxygen saturation and NTI values of subjects were recorded in tne basic state,during the 90s after lidocaine administration, 60s after propofol administration and consciousness loss.The control group simply replaced lidocaine with equal volume normal saline
Placebo Comparator: P group; Replace lidocaine with equal volume normal saline,Others are the same as the experimental group.	Drug: Normal saline; Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of patients with loss of consciousness	Effects of intravenous lidocaine on ED50 and ED95 of propofol induced unconsciousness	6 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of intravenous lidocaine on NTI values of propofol induced unconsciousness	The NTI values at T1,T2,T3 and T4 were recorded and statistically analyzed	6 hours

Collaborators and Investigators

• Sponsor: General Hospital of Ningxia Medical University
• Investigators: Principal Investigator: Guimei Ji, master, General Hospital of Ningxia Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 8, 2022
• Primary Completion (Anticipated): November 8, 2022
• Study Completion (Anticipated): November 25, 2022

Study Registration Dates

• First Submitted: September 30, 2022
• First Submitted That Met QC Criteria: October 7, 2022
• First Posted (Actual): October 10, 2022

Study Record Updates

• Last Update Posted (Actual): October 10, 2022
• Last Update Submitted That Met QC Criteria: October 7, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: propofol; ED50; ED95; intravinious lidocaine; NTI
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Consciousness Disorders; Unconsciousness; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: JGM 20220123

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No