AnesthesiaNCT02820025
The Effect and Mechanism of Respiratory Stimulant Doxapram on Facilitating Emergence
A study testing doxapram and saline in people with Anesthesia, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial summary
The current study is designed to investigate the difference of plasma orexin A levels between doxapram group and controlled group at emergence time from sevoflurane-remifentanil anesthesia who will undergo elective lumbar surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- doxapram and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Dec 2017
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is Adult (≥18 years old and ≤75 years old)
- Participants with a Body Mass Index (BMI) 20-25 kg/m2
- Participants with ASA physical status Ⅰor Ⅱ
- Participants with Heart function rating Ⅰor Ⅱ
- patients will undergo elective lumbar surgery and general anesthesia
- The operation time is 2h to 4h.
Who cannot join
- Participant is a pregnant woman or a nursing mother.
- Participants have a history of narcotics allergic reactions.
- indices of liver or kidney function is twice higher than normal.
- Participants have a history or diagnosis of depression.
- Participants have a history of Brain Trauma.
- Participants have a history of narcotics addiction or drug addiction.
- Participants or his family have an International Classification of Sleep Disorders diagnosis of obstructive sleep apnea syndrome.
- patients are refuse this trail or are not able to sign informed consent. -
Trial locations and contacts
1 site in 1 country.
China1 site
Anesthesiology department of General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
About this study
Official title: To Investigate the Effect and Mechanism of Respiratory Stimulant Doxapram on Facilitating Emergence From General Anesthesia Undergoing Elective Lumbar Surgery
The current study is designed to investigate the difference of plasma orexin A levels between doxapram group and controlled group at emergence time from sevoflurane-remifentanil anesthesia who will undergo elective lumbar surgery.
Read the detailed description
BACKGROUND: General anesthesia has been widely used in clinics, while its mechanism is not fully clear.Delayed emergence from general anesthesia happens from time to time, which increases the occurrence of complications and economic burden of patients. The analeptics currently used in clinic have some side effects. Recently,studies have shown that orexin can facilitate emergence from general anesthesia.Because of its complex chemical structure and difficulty of synthetic process, a mountain of works needs to be done before its use in clinic. Doxapram has been widely used as a respiratory stimulant on patients. Recently the investigators found in patient that intravenous injection of doxapram would shorten the emergence time from general anesthesia, while its associated mechanism is unclear. Based on our previous discovery that injection of doxapram in patients could increase the plasma level of orexin - A, the investigators hypothesized that doxapram probably facilitate emergence from general anesthesia by promoting the release of orexin.
DESIGNING: Forty patients with ASA physical status I or II scheduled for elective lumbar surgery under general anesthesia (lasting for 2h to 4h) were enrolled. Anesthesia was induced with propofol 1-2mg/kg and sufentanyl 0.2-0.3μg/kg. Following muscle relaxation with iv cisatracurium besylate 0.2mg/kg endotracheal intubation was performed. Anesthesia was maintained with sevoflurane (inhalational concentration: 0.8-2.0 MAC) and target controlled infusion remifentanil (targeted concentration:2-6ng/ml ) along with an oxygen/air mixture (FiO2 =0.5). Muscle relaxation was maintained with intermittent. Inhalational concentration of sevoflurane and injected target concentration were titrated to maintain the bispectral index (BIS) between 40 and 60 during anesthesia. The end-tidal carbon dioxide level was maintained between 30 and 40 mmHg by controlled mechanical ventilation. When the surgery was completed the investigators adjust the concentration sevoflurane to 0.8MAC of the patient and targeted concentration of remifentanil to 2ng/ml then stop all anesthetics and adjust the oxygen flow to 6.0 L/min, at the same time the doxapram group iv doxapram 1mg/kg, the controlled group given equal volume of saline. Record time from stopping anesthetics to emergence. Arterial blood (2ml) was collected at the following time,such as before and 1h after induction of anesthesia, at emergence (1 min after tracheal extubation) and half an hour after tracheal extubation. This was centrifuged at 3000 rpm for 15min at -4 ◦C in order to separate plasma then stored at -80 ◦C until assay for orexin A concentrations.
EXPECTED RESULTS: The plasma orexin A of the doxapram group will be higher with the emergence time shorter than the controlled group.
- Conditions
- Anesthesia
- Being tested
- doxapram, saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doxapramDrug
salineOther
| Study group | Role | What they receive |
|---|---|---|
| doxapram group | Experimental | the doxapram group iv doxapram 1mg/kg, Receives: Drug: doxapram |
| Controlled group | Placebo comparator | the controlled group given equal volume of saline with the doxapram group. Receives: Other: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
orexin A concentrations
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startOct 2015
- Primary completionApr 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhihua Wang, M.D., Study chair, General Hospital of Ningxia Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820025
- Sponsor's protocol ID
- mzk2015orexin
- Status last verified
- Jan 2017
- First submitted
- 25 May 2016
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Investigate the Effect and Mechanism of Respiratory Stimulant Doxapram on Facilitating Emergence From General Anesthesia Undergoing Elective Lumbar Surgery
- ClinicalTrials.gov ID
- NCT02820025
- Acronym / sponsor ID
- mzk2015orexin
- Conditions
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 30 Jun 2016 (estimated)
- 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 current study is designed to investigate the difference of plasma orexin A levels between doxapram group and controlled group at emergence time from sevoflurane-remifentanil anesthesia who will undergo elective lumbar surgery.
Detailed description
BACKGROUND: General anesthesia has been widely used in clinics, while its mechanism is not fully clear.Delayed emergence from general anesthesia happens from time to time, which increases the occurrence of complications and economic burden of patients. The analeptics currently used in clinic have some side effects. Recently,studies have shown that orexin can facilitate emergence from general anesthesia.Because of its complex chemical structure and difficulty of synthetic process, a mountain of works needs to be done before its use in clinic. Doxapram has been widely used as a respiratory stimulant on patients. Recently the investigators found in patient that intravenous injection of doxapram would shorten the emergence time from general anesthesia, while its associated mechanism is unclear. Based on our previous discovery that injection of doxapram in patients could increase the plasma level of orexin - A, the investigators hypothesized that doxapram probably facilitate emergence from general anesthesia by promoting the release of orexin.
DESIGNING: Forty patients with ASA physical status I or II scheduled for elective lumbar surgery under general anesthesia (lasting for 2h to 4h) were enrolled. Anesthesia was induced with propofol 1-2mg/kg and sufentanyl 0.2-0.3μg/kg. Following muscle relaxation with iv cisatracurium besylate 0.2mg/kg endotracheal intubation was performed. Anesthesia was maintained with sevoflurane (inhalational concentration: 0.8-2.0 MAC) and target controlled infusion remifentanil (targeted concentration:2-6ng/ml ) along with an oxygen/air mixture (FiO2 =0.5). Muscle relaxation was maintained with intermittent. Inhalational concentration of sevoflurane and injected target concentration were titrated to maintain the bispectral index (BIS) between 40 and 60 during anesthesia. The end-tidal carbon dioxide level was maintained between 30 and 40 mmHg by controlled mechanical ventilation. When the surgery was completed the investigators adjust the concentration sevoflurane to 0.8MAC of the patient and targeted concentration of remifentanil to 2ng/ml then stop all anesthetics and adjust the oxygen flow to 6.0 L/min, at the same time the doxapram group iv doxapram 1mg/kg, the controlled group given equal volume of saline. Record time from stopping anesthetics to emergence. Arterial blood (2ml) was collected at the following time,such as before and 1h after induction of anesthesia, at emergence (1 min after tracheal extubation) and half an hour after tracheal extubation. This was centrifuged at 3000 rpm for 15min at -4 ◦C in order to separate plasma then stored at -80 ◦C until assay for orexin A concentrations.
EXPECTED RESULTS: The plasma orexin A of the doxapram group will be higher with the emergence time shorter than the controlled group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| doxapram group | Experimental | Drug: doxapramthe doxapram group iv doxapram 1mg/kg, |
| Controlled group | Placebo comparator | Other: salinethe controlled group given equal volume of saline with the doxapram group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant is Adult (≥18 years old and ≤75 years old)
- Participants with a Body Mass Index (BMI) 20-25 kg/m2
- Participants with ASA physical status Ⅰor Ⅱ
- Participants with Heart function rating Ⅰor Ⅱ
- patients will undergo elective lumbar surgery and general anesthesia
Key exclusion criteria (8 listed)
- Participant is a pregnant woman or a nursing mother.
- Participants have a history of narcotics allergic reactions.
- indices of liver or kidney function is twice higher than normal.
- Participants have a history or diagnosis of depression.
- Participants have a history of Brain Trauma.
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 |
|---|---|---|
| doxapram | Drug | doxapram group |
| saline | Other | Controlled group |
Primary outcome
orexin A concentrations
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- Individual participant dataSharing planned: Undecided
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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.
Zhihua Wang, M.D. study chair
General Hospital of Ningxia Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing doxapram and saline in people with Anesthesia, run by General Hospital of Ningxia Medical University 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 6 inclusion and 8 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 18 Jan 2017. 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. 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.
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?
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?
orexin A concentrations (time frame: 1 year). 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 18 Jan 2017.