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The Effect and Mechanism of Respiratory Stimulant Doxapram on Facilitating Emergence

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ClinicalTrials.gov Identifier: NCT02820025
Recruitment Status : Unknown
Verified January 2017 by General Hospital of Ningxia Medical University.
Recruitment status was:  Active, not recruiting
First Posted : June 30, 2016
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
General Hospital of Ningxia Medical University

Tracking Information
First Submitted Date  ICMJE May 25, 2016
First Posted Date  ICMJE June 30, 2016
Last Update Posted Date January 18, 2017
Study Start Date  ICMJE October 2015
Estimated Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2016)
orexin A concentrations [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect and Mechanism of Respiratory Stimulant Doxapram on Facilitating Emergence
Official Title  ICMJE To Investigate the Effect and Mechanism of Respiratory Stimulant Doxapram on Facilitating Emergence From General Anesthesia Undergoing Elective Lumbar Surgery
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Anesthesia
Intervention  ICMJE
  • Drug: doxapram
  • Other: saline
Study Arms  ICMJE
  • Experimental: doxapram group
    the doxapram group iv doxapram 1mg/kg,
    Intervention: Drug: doxapram
  • Placebo Comparator: Controlled group
    the controlled group given equal volume of saline with the doxapram group.
    Intervention: Other: saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: June 29, 2016)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Participant is Adult (≥18 years old and ≤75 years old)
  2. Participants with a Body Mass Index (BMI) 20-25 kg/m2
  3. Participants with ASA physical status Ⅰor Ⅱ
  4. Participants with Heart function rating Ⅰor Ⅱ
  5. patients will undergo elective lumbar surgery and general anesthesia
  6. The operation time is 2h to 4h.

Exclusion Criteria:

  1. Participant is a pregnant woman or a nursing mother.
  2. Participants have a history of narcotics allergic reactions.
  3. indices of liver or kidney function is twice higher than normal.
  4. Participants have a history or diagnosis of depression.
  5. Participants have a history of Brain Trauma.
  6. Participants have a history of narcotics addiction or drug addiction.
  7. Participants or his family have an International Classification of Sleep Disorders diagnosis of obstructive sleep apnea syndrome.
  8. patients are refuse this trail or are not able to sign informed consent. -
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02820025
Other Study ID Numbers  ICMJE mzk2015orexin
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party General Hospital of Ningxia Medical University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE General Hospital of Ningxia Medical University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Zhihua Wang, M.D. General Hospital of Ningxia Medical University
PRS Account General Hospital of Ningxia Medical University
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP