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The Effect of Orexin on Delayed Emergence of General Anesthesia in Dexmedetomidine

Sponsor
General Hospital of Ningxia Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT03025295
Collaborator
(none)
51
Enrollment
1
Location
2
Arms
14.9
Actual Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The current study is designed to investigate the difference of plasma orexin A levels between Dexmedetomidine group and controlled group at emergence time from total intravenous anesthesia who will undergo elective lumbar surgery.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

DESIGNING: Fifty-one patients with ASA physical status I or II scheduled for elective 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 target controlled infusion propofol (targeted concentration:2-5ug/ml ) and remifentanil (targeted concentration: 2-6ng/ml ). Muscle relaxation was maintained with intermittent, but it do not injected in 1h before surgery completion. Propofol and remifentanil 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 targeted concentration of propofol 2ug/ml and targeted concentration of remifentanil to 2ng/ml then stop all anesthetics. Dexmedetomidine group target controlled infusion dexmedetomidine (induction dose 1ug/kg with 10min, maintain dose 0.4ug/kg/h until 30min before surgery completion). Control group infusion same saline. Record time from stopping anesthetics to emergence and total doses of anesthetics. Arterial blood (2.5ml) 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. 2.0ml Arterial blood 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. 0.5ml Arterial blood was measured blood glucose.

Study Design

Study Type:
Interventional
Actual Enrollment :
51 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
The Effect of Orexin on Delayed Emergence of General Anesthesia in Dexmedetomidine
Actual Study Start Date :
Feb 1, 2017
Actual Primary Completion Date :
Apr 30, 2018
Actual Study Completion Date :
Apr 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dexmedetomidine group

Induction dose of dexmedetomidine is 1ug/kg with 10min, maintain dose is 0.4ug/kg/h until 30 min before surgery completion.

Drug: Dexmedetomidine
Dexmedetomidine is common used to improve the prognosis and life quality of patients.
Other Names:
  • Dexmedetomidine is a highly selective α2-adrenoceptor agonist.

    		•
    Placebo Comparator: Saline group

    Control group given equal volume of saline with the dexmedetomidine group.

    Drug: Saline
    It is safe Placebo.
    Other Names:
  • It is safe Placebo.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. orexin A concentrations [2 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Participant is Adult (≥18 years old and ≤60 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 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

    8. Disorders diagnosis of obstructive sleep apnea syndrome.

    9. Patients are refuse this trail or are not able to sign informed consent.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anesthesiology department of General Hospital of Ningxia Medical University Yinchuan Ningxia China 750004

    Sponsors and Collaborators

    • General Hospital of Ningxia Medical University

    Investigators

    • Study Chair: Zhihua Wang, M.D., General Hospital of Ningxia Medical University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    General Hospital of Ningxia Medical University
    ClinicalTrials.gov Identifier:
    NCT03025295
    Other Study ID Numbers:
    • XZ2015020
    First Posted:
    Jan 19, 2017
    Last Update Posted:
    Jun 23, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dexmedetomidine

    Study Results

    No Results Posted as of Jun 23, 2021