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Effect of Dexmedetomidine on Levels of Plasma Inflammatory Factor in Asthma Patients Undergoing General Anesthesia

Effect of Dexmedetomidine on Levels of Plasma Inflammatory Factor in Asthma Patients Undergoing General Anesthesia-single Center,Randomized,Double-blind,Controlled Trial

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02289391
Enrollment
80
Registered
2014-11-13
Start date
2014-12-31
Completion date
2015-12-31
Last updated
2014-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Asthma

Keywords

Dexmedetomidine, Inflammatory factor, Inflammatory mediator, Cytokines, Asthma

Brief summary

The study try to illustrate the possible mechanisms of tending to induce airway spasms and the impact of dexmedetomidine on inflammatory reaction in general anesthesia patients with asthma,by detecting the differences of plasma inflammatory factor interleukin(IL)-4, IL-5, IL-13, IL-17, IL-33, MBP and immunoglobulin E(IgE) levels between asthma patients and non-asthma patients.

Interventions

DRUGAnesthesia induction

-Intravenous injection midazolam 0.05 mg/Kg,fentanyl 4μg/Kg,etomidate 0.2 mg/Kg,cisatracurium 0.15 mg/Kg in proper order.

* Continuous intravenous remifentanil O.2μg/(kg•h) and propofol 3\ 8mg/(kg•h). * Intermittent intravenous atracurium 0.05mg/kg. Maintain partial pressure of carbon dioxide(PETCO2) to 30\ 40 mmHg and bispectral index (BIS) to 45\ 60.

DRUGAssisted anesthesia

Intervention 'Assisted anesthesia' has been included in Arm Descriptions.

Sponsors

Second Affiliated Hospital of Xi'an Jiaotong University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Obtain informed consent * Elective general anesthesia surgery, surgery time 1 \ 3 hours. * 20 patients with a history of asthma. * 60 patients with no history of asthma. * American Society of Anesthesiologists (ASA)classification:class I\ II. * Aged between 18 and 65 years old.

Exclusion criteria

* SBP≥180 mmHg or \<90 mmHg, DBP≥110 mmHg or \<60 mmHg. * Serious heart, brain, liver, kidney, lung, endocrine diseases or serious infections. * Hematopoietic dysfunction or bleeding tendency and hemorrhagic disease. * A neuromuscular system disease. * Airway and lung surgery. * Predict possible or happened difficult airway. * Immune function defect. * Sure/suspected abuse of narcotic analgesics or drugs or alcohol dependence. * The test drug allergy or have other contraindications in patients. * Childbearing age women not to take appropriate contraception, pregnancy or lactation. * Participated in other clinical drug research in the last 30 days.

Design outcomes

Primary

MeasureTime frame
IL-4,IL-5,IL-13, IL-17, IL-33 concentration in the Plasmaenter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
Histamine concentrationenter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
Myelin Basic Protein concentration (MBP)enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
IgE concentrationenter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)

Secondary

MeasureTime frame
Heart rate(HR)enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
Respiratory rate(RR)enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)
Mean arterial pressure(MAP)enter the operation room(T0)、10min after intubation(T1)、 skin incision(T2)、the end of surgery(T3)、24H after surgery(T4)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026