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

Phase 1

Not yet recruiting

• Conditions: General Anesthesia
• Interventions: Drug: Normal saline; Drug: Lidocaine

• Registration Number: NCT05573191
• Lead Sponsor: General Hospital of Ningxia Medical University

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 .

Study Timeline

• Study First Submitted: 2022-09-30
• Status Verified: 2022-10
• Study First Submitted QC: 2022-10-07
• Last Update Submitted: 2022-10-07
• Study Start: 2022-10-08
• Study First Posted: 2022-10-10
• Last Update Posted: 2022-10-10
• Primary Completion: 2022-11-08
• Study Completion: 2022-11-25

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P group	Normal saline	Replace lidocaine with equal volume normal saline,Others are the same as the experimental group.
LP group	Lidocaine	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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

General Hospital of Ningxia Medical University; 🇨🇳 Yinchuan, Ningxia, China

GuiMei Ji; 🇨🇳 Yinchuan, Ningxia, China