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NCT05573191 Clinical Trial

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

General Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05573191
Other study ID # JGM 20220123
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date October 8, 2022
Est. completion date November 25, 2022

Study information
Verified date October 2022
Source General Hospital of Ningxia Medical University
Contact GuiMei Ji, master
Phone 13619587243
Email 1987780277@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 .

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 .

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date November 25, 2022
Est. primary completion date November 8, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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
• Normal saline
Normal saline

Locations
Country Name City State
China General Hospital of Ningxia Medical University Yinchuan Ningxia
China GuiMei Ji Yinchuan Ningxia

Sponsors (1)
Lead Sponsor Collaborator
General Hospital of Ningxia Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The number of patients with loss of consciousness Effects of intravenous lidocaine on ED50 and ED95 of propofol induced unconsciousness 6 hours
Secondary 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
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