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

NCT ID: NCT05573191

Last Updated: 2022-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-08

Study Completion Date

2022-11-25

Brief Summary

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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

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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 .

Conditions

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General Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

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

P group

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

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Normal saline

Interventions

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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

Intervention Type DRUG

Normal saline

Normal saline

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General Hospital of Ningxia Medical University

OTHER

Sponsor Role lead

Responsible Party

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Hanxiang Ma

Director of department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guimei Ji, master

Role: PRINCIPAL_INVESTIGATOR

General Hospital of Ningxia Medical University

Locations

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General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Site Status

GuiMei Ji

Yinchuan, Ningxia, China

Site Status

Countries

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China

Central Contacts

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GuiMei Ji, master

Role: CONTACT

13619587243

Facility Contacts

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Hanxiang Ma, master

Role: primary

+86-13519591508

Hanxiang Ma, master

Role: primary

13519591508

Other Identifiers

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JGM 20220123

Identifier Type: -

Identifier Source: org_study_id

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