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

Primary Purpose

General Anesthesia

Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Lidocaine
Normal saline
Sponsored by
General Hospital of Ningxia Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for General Anesthesia focused on measuring ED50, ED95, intravinious lidocaine, propofol, NTI

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • General Hospital of Ningxia Medical University
  • GuiMei Ji

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LP group

P group

Arm Description

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

Replace lidocaine with equal volume normal saline,Others are the same as the experimental group.

Outcomes

Primary Outcome Measures

The number of patients with loss of consciousness
Effects of intravenous lidocaine on ED50 and ED95 of propofol induced unconsciousness

Secondary Outcome Measures

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

Full Information

First Posted
September 30, 2022
Last Updated
October 7, 2022
Sponsor
General Hospital of Ningxia Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05573191
Brief Title
Effects of Intravenous Lidocaine on ED50, ED95 and NTI Values of Propofol Induced Unconsciousness
Official Title
Effects of Intravenous Lidocaine on ED50, ED95 and NTI Values of Propofol Induced Unconsciousness
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 8, 2022 (Anticipated)
Primary Completion Date
November 8, 2022 (Anticipated)
Study Completion Date
November 25, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General Hospital of Ningxia Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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 .
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
General Anesthesia
Keywords
ED50, ED95, intravinious lidocaine, propofol, NTI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LP group
Arm Type
Experimental
Arm Description
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
Arm Title
P group
Arm Type
Placebo Comparator
Arm Description
Replace lidocaine with equal volume normal saline,Others are the same as the experimental group.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Normal saline
Primary Outcome Measure Information:
Title
The number of patients with loss of consciousness
Description
Effects of intravenous lidocaine on ED50 and ED95 of propofol induced unconsciousness
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Effects of intravenous lidocaine on NTI values of propofol induced unconsciousness
Description
The NTI values at T1,T2,T3 and T4 were recorded and statistically analyzed
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The informed consent is signed Aged 18 to 65 years old ASA is rated from I to II Body mass index ranged from 18.5 to 24.9 kg/m2 Exclusion Criteria: Unwilling to sign informed consent or refuse to participate in the study Patients with serious arrhythmia and organic heart disease before surgery Sedative and analgesic drugs were taken within 1 week before surgery Lidocaine allergy Patients with mental and neurological diseases Patients with difficult airway People with hearing impairment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
GuiMei Ji, master
Phone
13619587243
Email
1987780277@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guimei Ji, master
Organizational Affiliation
General Hospital of Ningxia Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanxiang Ma, master
Phone
+86-13519591508
Email
mahanxiang@hotmail.com
Facility Name
GuiMei Ji
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
756000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanxiang Ma, master
Phone
13519591508

12. IPD Sharing Statement

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

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