General AnesthesiaPhase 1/2NCT05573191
Effects of Intravenous Lidocaine on ED50, ED95 and NTI Values of Propofol Induced Unconsciousness
A Phase 1/2 study testing Lidocaine and Normal saline in people with General Anesthesia, run by General Hospital of Ningxia Medical University at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- General Anesthesia
- What is being tested?
- Lidocaine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 8 Oct 2022to 25 Nov 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The informed consent is signed
- Aged 18 to 65 years old
- ASA is rated from I to II
- Body mass index ranged from 18.5 to 24.9 kg/m2
Who cannot join
- Unwilling to sign informed consent or refuse to participate in the study
- Patients with serious arrhythmia and organic heart disease before surgery
- Sedative and analgesic drugs were taken within 1 week before surgery
- Lidocaine allergy
- Patients with mental and neurological diseases
- Patients with difficult airway
- People with hearing impairment
Trial locations and contacts
2 sites in 1 country.
China2 sites
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
Hanxiang Ma, master, +86-13519591508, mahanxiang@hotmail.com
GuiMei Ji
Yinchuan, Ningxia, 756000
Hanxiang Ma, master, 13519591508
About this study
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 .
Read the 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 .
- Conditions
- General Anesthesia
- Being tested
- Lidocaine, Normal saline
- Keywords
- ED50, ED95, intravinious lidocaine, propofol, NTI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
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 salineDrug
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| LP group | Experimental | 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 Receives: Drug: Lidocaine |
| P group | Placebo comparator | Replace lidocaine with equal volume normal saline,Others are the same as the experimental group. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with loss of consciousness
Effects of intravenous lidocaine on ED50 and ED95 of propofol induced unconsciousness
Measured: 6 hours
Secondary outcomes (1)
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
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start8 Oct 2022 (estimated)
- Primary completion8 Nov 2022 (estimated)
- Study completion25 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanxiang Ma, General Hospital of Ningxia Medical University
- Investigators
- Guimei Ji, master, Principal investigator, General Hospital of Ningxia Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573191
- Sponsor's protocol ID
- JGM 20220123
- Status last verified
- Oct 2022
- First submitted
- 30 Sep 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intravenous Lidocaine on ED50, ED95 and NTI Values of Propofol Induced Unconsciousness
- ClinicalTrials.gov ID
- NCT05573191
- Acronym / sponsor ID
- JGM 20220123
- Conditions
- General Anesthesia
- Keywords
- ED50, ED95, intravinious lidocaine, propofol, NTI
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 8 Oct 2022 (estimated)
- Primary completion
- 8 Nov 2022 (estimated)
- Study completion
- 25 Nov 2022 (estimated)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LP group | Experimental | Drug: LidocaineThe 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 |
| P group | Placebo comparator | Drug: Normal salineReplace lidocaine with equal volume normal saline,Others are the same as the experimental group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The informed consent is signed
- Aged 18 to 65 years old
- ASA is rated from I to II
- Body mass index ranged from 18.5 to 24.9 kg/m2
Key exclusion criteria (7 listed)
- Unwilling to sign informed consent or refuse to participate in the study
- Patients with serious arrhythmia and organic heart disease before surgery
- Sedative and analgesic drugs were taken within 1 week before surgery
- Lidocaine allergy
- Patients with mental and neurological diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineThe 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 | Drug | LP group |
| Normal salineNormal saline | Drug | P group |
Primary outcome
The number of patients with loss of consciousness
Time frame: 6 hours
Effects of intravenous lidocaine on ED50 and ED95 of propofol induced unconsciousness
1 secondary outcome
Effects of intravenous lidocaine on NTI values of propofol induced unconsciousness
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guimei Ji, master principal investigator
General Hospital of Ningxia Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lidocaine and Normal saline in people with General Anesthesia, run by General Hospital of Ningxia Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GuiMei Ji, master (13619587243, 1987780277@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients with loss of consciousness (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.