Nociceptive PainPhase 3NCT03841812
Comparation Analgesia Efficiency With Propofol Combine Sevoflurane vs Propofol
A Phase 3 study testing 5mg/kg/h Propofol, Sevoflurane and 2 mg/kg/h Propofol in people with Nociceptive Pain and Analgesic Adverse Reaction, run by China International Neuroscience Institution at 1 site in China.
Trial summary
This study purpose to compare analgesia efficiency of propofol combine with sevoflurane with propofol only using index of Nociception (NOX) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nociceptive Pain, Analgesic Adverse Reaction, Inhalant Use
- What is being tested?
- 5mg/kg/h Propofol, Sevoflurane and 2 mg/kg/h Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2020to 1 Jul 2020
- Phase
- Phase 3
- 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
- Participants were aged 18-65 years old,
- American Society of Anesthesiologists (ASA) physical status I, II or III
- scheduled to have urological surgery(would last longer than 1 h)
- requiring general anesthesia.
Who cannot join
- refused to participate in this study;
- Unable to communicate normally because of consciousness alterations;
- a history of allergy to opioids
- contraindications to inhalational anesthesia
- a family history of malignant hyperthermia
- a history of alcohol or drug abuse
Show all 19Show fewer
- received central nervous system-active drugs
- super obese as defined by a body mass index ≥40 kg/m2
- conditions liable to alter the pharmacokinetic and pharmacodynamic behaviors of the intravenous and inhalation anesthetics
- previous head injury
- neurologic
- psychiatric disease
- any disabling central nervous
- cerebrovascular disease
- using psychoactive
- anti-convulsive medications at the time
- unstable angina
- manifested congestive heart failure
- expected difficulty airway management
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparation Analgesia Efficiency With Propofol Combine Sevoflurane vs Propofol Using Index of Nociception (NOX)
This study purpose to compare analgesia efficiency of propofol combine with sevoflurane with propofol only using index of Nociception (NOX)
Read the detailed description
- Recently study found sevoflurane plays an important role through spinal nerve peptide receptor (NK.1R), glycine receptor (GlyR), neuron nicotinic receptor (nnAChRs), Methyl-1-methyl-1-day aspartate (NMDA receptor), and TRPV1 receptor (TRPV1 receptor) produce the analgesic efficiency.
- propofol was traditional sedation reagent.
- index of Nociception (NOX) was the objective index for analgesia This study purpose to compare analgesia efficiency of Only Propofol and sevoflurane combine with propofol using index of Nociception (NOX)
- Conditions
- Nociceptive Pain, Analgesic Adverse Reaction, Inhalant Use
- Being tested
- 5mg/kg/h Propofol, Sevoflurane, 2 mg/kg/h Propofol
- Medical subject headings
- Nociceptive Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5mg/kg/h PropofolDrug
Also called 5mg/kg/h Propofol Injection
5mg/kg/h Propofol continuously infused during intre-operation
SevofluraneDrug
Also called 1% Sevoflurane
1% Sevoflurane continuously using during intre-operation.
2 mg/kg/h PropofolDrug
2mg/kg/h Propofol continuously infused during intre-operation
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Experimental | 5mg/kg/h Propofol continue infusion during the maintain of anesthesia during the maintain of anesthesia. Receives: Drug: 5mg/kg/h Propofol |
| Propofol & Sevoflurane | Experimental | 2mg/kg/h Propofol \& 1% Sevoflurane group continue infusion(Balance anesthesia) during the maintain of anesthesia Receives: Drug: Sevoflurane; Drug: 2 mg/kg/h Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
qNOX change
Nociception of index (qNOX) difference between two groups. The nociception index (NOX) derived from electroencephalogram (EEG) signals has been proposed as a noninvasive guide to indicate anesthesia depth. The neurological processing of noxious stimuli is defined as nociception. NOX ranges from 0-99, and the lower the index, the deeper the state of analgesia. NOX lower than 20 represents deep analgesia, and higher than 80 represents inadequate analgesia.
Measured: during operation
Secondary outcomes (3)
PACU duration
Post anesthesia care unit duration(PACU duration). The longer PACU duration indicate the worse situation of the patients
Measured: 24 hours
PONV difference between two groups
postoperative nausea and vomiting ratio(PONV) difference between two groups. The more frequency of PONV, the worst comfortable outcome of the patients
Measured: 24 hours
Post- operative pain difference between two groups
Post- operative pain difference between two groups using VAS(Visual analogue rating) Score evaluation. Pain was assessed 24 h post operation using a 0-10 numeric pain rating scale (VAS scale), where zero meant no pain and 10 meant the worst imaginable pain.VAS score (Post-operation 24 h) (0-1 VAS indicate None pain; 2-5 VAS indicate Moderate pain; 6-10 VAS indicate severe pain)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start20 Jan 2020
- Primary completion1 Jun 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nociceptive PainStudies 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 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- China International Neuroscience Institution
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ke Huang, MS, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841812
- Sponsor's protocol ID
- CINI-ZYLX-201809-50
- Status last verified
- Jan 2020
- First submitted
- 19 Jan 2019
- Last updated
- 14 Oct 2020
- 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 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparation Analgesia Efficiency With Propofol Combine Sevoflurane vs Propofol Using Index of Nociception (NOX)
- ClinicalTrials.gov ID
- NCT03841812
- Acronym / sponsor ID
- CINI-ZYLX-201809-50
- Conditions
- Nociceptive Pain, Analgesic Adverse Reaction, Inhalant Use
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- China International Neuroscience InstitutionUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 15 Feb 2019 (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.
This study purpose to compare analgesia efficiency of propofol combine with sevoflurane with propofol only using index of Nociception (NOX)
Detailed description
- Recently study found sevoflurane plays an important role through spinal nerve peptide receptor (NK.1R), glycine receptor (GlyR), neuron nicotinic receptor (nnAChRs), Methyl-1-methyl-1-day aspartate (NMDA receptor), and TRPV1 receptor (TRPV1 receptor) produce the analgesic efficiency.
- propofol was traditional sedation reagent.
- index of Nociception (NOX) was the objective index for analgesia This study purpose to compare analgesia efficiency of Only Propofol and sevoflurane combine with propofol using index of Nociception (NOX)
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Experimental | Drug: 5mg/kg/h Propofol5mg/kg/h Propofol continue infusion during the maintain of anesthesia during the maintain of anesthesia. |
| Propofol & Sevoflurane | Experimental | Drug: Sevoflurane, Drug: 2 mg/kg/h Propofol2mg/kg/h Propofol \& 1% Sevoflurane group continue infusion(Balance anesthesia) during the maintain of anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants were aged 18-65 years old,
- American Society of Anesthesiologists (ASA) physical status I, II or III
- scheduled to have urological surgery(would last longer than 1 h)
- requiring general anesthesia.
Key exclusion criteria (19 listed)
- refused to participate in this study;
- Unable to communicate normally because of consciousness alterations;
- a history of allergy to opioids
- contraindications to inhalational anesthesia
- a family history of malignant hyperthermia
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 |
|---|---|---|
| 5mg/kg/h PropofolAlso: 5mg/kg/h Propofol Injection5mg/kg/h Propofol continuously infused during intre-operation | Drug | Propofol |
| SevofluraneAlso: 1% Sevoflurane1% Sevoflurane continuously using during intre-operation. | Drug | Propofol & Sevoflurane |
| 2 mg/kg/h Propofol2mg/kg/h Propofol continuously infused during intre-operation | Drug | Propofol & Sevoflurane |
Primary outcome
qNOX change
Time frame: during operation
Nociception of index (qNOX) difference between two groups. The nociception index (NOX) derived from electroencephalogram (EEG) signals has been proposed as a noninvasive guide to indicate anesthesia depth. The neurological processing of noxious stimuli is defined as nociception. NOX ranges from 0-99, and the lower the index, the deeper the state of analgesia. NOX lower than 20 represents deep analgesia, and higher than 80 represents inadequate analgesia.
3 secondary outcomes
PACU duration
Time frame: 24 hours
PONV difference between two groups
Time frame: 24 hours
Post- operative pain difference between two groups
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
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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.
Ke Huang, MS principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5mg/kg/h Propofol, Sevoflurane and 2 mg/kg/h Propofol in people with Nociceptive Pain and Analgesic Adverse Reaction, run by China International Neuroscience Institution at 1 site 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 19 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: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
qNOX change (time frame: during operation). 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 14 Oct 2020.