NCT05573191

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 .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2022

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

October 8, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2022

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2022

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2022

Completed
Last Updated

October 10, 2022

Status Verified

October 1, 2022

Enrollment Period

1 month

First QC Date

September 30, 2022

Last Update Submit

October 7, 2022

Conditions

General Anesthesia

Keywords

ED50ED95intravinious lidocainepropofolNTI

Outcome Measures

Primary Outcomes (1)

  • The number of patients with loss of consciousness

    Effects of intravenous lidocaine on ED50 and ED95 of propofol induced unconsciousness

    6 hours

Secondary Outcomes (1)

  • Effects of intravenous lidocaine on NTI values of propofol induced unconsciousness

    6 hours

Study Arms (2)

LP group

EXPERIMENTAL

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

P group

PLACEBO COMPARATOR

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

Drug: Normal saline

Interventions

LidocaineDRUG

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

LP group
Normal salineDRUG

Normal saline

P group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

GuiMei Ji

Yinchuan, Ningxia, 756000, China

Location

MeSH Terms

Interventions

LidocaineSaline Solution

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Guimei Ji, master

    General Hospital of Ningxia Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

GuiMei Ji, master

CONTACT

136195872431987780277@qq.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of department

Study Record Dates

First Submitted

September 30, 2022

First Posted

October 10, 2022

Study Start

October 8, 2022

Primary Completion

November 8, 2022

Study Completion

November 25, 2022

Last Updated

October 10, 2022

Record last verified: 2022-10

Locations

CN(2)