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

• Sponsor: General Hospital of Ningxia Medical University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05573191
• Collaborator: (none)
• Enrollment: 100
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 1.6
• Patients Per Site: 50
• Patients Per Site Per Month: 31.7

Study Details

Study Description

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 .

Condition or Disease	Intervention/Treatment	Phase
General Anesthesia	Drug: Lidocaine; Drug: Normal saline	Phase 1/Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Effects of Intravenous Lidocaine on ED50, ED95 and NTI Values of Propofol Induced Unconsciousness
• Anticipated Study Start Date: Oct 8, 2022
• Anticipated Primary Completion Date: Nov 8, 2022
• Anticipated Study Completion Date: Nov 25, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	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
Placebo Comparator: P group Replace lidocaine with equal volume normal saline,Others are the same as the experimental group.	Drug: Normal saline; Normal saline

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	General Hospital of Ningxia Medical University	Yinchuan	Ningxia	China	750004
2	GuiMei Ji	Yinchuan	Ningxia	China	756000

Sponsors and Collaborators

• General Hospital of Ningxia Medical University

Investigators

• Principal Investigator: Guimei Ji, master, General Hospital of Ningxia Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hanxiang Ma, Director of department, General Hospital of Ningxia Medical University
• ClinicalTrials.gov Identifier: NCT05573191
• Other Study ID Numbers: JGM 20220123
• First Posted: Oct 10, 2022
• Last Update Posted: Oct 10, 2022
• Last Verified: Oct 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hanxiang Ma, Director of department, General Hospital of Ningxia Medical University: ED50; ED95; intravinious lidocaine; propofol; NTI
• Additional relevant MeSH terms: Unconsciousness; Lidocaine

Study Results

No Results Posted as of Oct 10, 2022