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

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05573191

Enrollment

100

Registered

2022-10-10

Start date

2022-10-08

Completion date

2022-11-25

Last updated

2022-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthesia

Keywords

ED50, ED95, intravinious lidocaine, propofol, NTI

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 .

Interventions

DRUGLidocaine

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

DRUGNormal saline

Normal saline

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

China

Contacts

Primary ContactGuiMei Ji, master

1987780277@qq.com13619587243

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026