The Effect and Mechanism of Respiratory Stimulant Doxapram on Facilitating Emergence
To Investigate the Effect and Mechanism of Respiratory Stimulant Doxapram on Facilitating Emergence From General Anesthesia Undergoing Elective Lumbar Surgery
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 25, 2016
CompletedFirst Posted
Study publicly available on registry
June 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJanuary 18, 2017
January 1, 2017
1.5 years
May 25, 2016
January 17, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
orexin A concentrations
1 year
Study Arms (2)
doxapram group
EXPERIMENTALthe doxapram group iv doxapram 1mg/kg,
Controlled group
PLACEBO COMPARATORthe controlled group given equal volume of saline with the doxapram group.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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. -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Anesthesiology department of General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Zhihua Wang, M.D.
General Hospital of Ningxia Medical University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2016
First Posted
June 30, 2016
Study Start
October 1, 2015
Primary Completion
April 1, 2017
Study Completion
December 1, 2017
Last Updated
January 18, 2017
Record last verified: 2017-01