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

Xi'an Jiaotong University

Status and phase: Unknown; Phase 4

Conditions: Asthma; Anesthesia

Treatments: Drug: Assisted anesthesia; Drug: Anesthesia maintenance; Drug: Anesthesia induction

Study type: Interventional

Funder types: Other

Identifiers

NCT02289391

Dexmedetomidine-14115

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

80 participants in 4 patient groups, including a placebo group

non-asthma group

Placebo Comparator group

Description:

* Non-asthma history * Infusion of normal saline(1μg/kg) at 10 minutes before anesthesia induction. * Infusion of normal saline at 0.4μg•kg-1•h-1during anesthesia maintenance. * Stop infusion of normal saline at 10 minutes before the end of surgery.

Treatment:

Drug: Anesthesia induction

Drug: Anesthesia maintenance

Dexmedetomidine A

Experimental group

Description:

* With a history of asthma * Infusion of dexmedetomidine(1μg/kg) at 10 minutes before anesthesia induction. * Infusion of dexmedetomidine at 0.4μg•kg-1•h-1during anesthesia maintenance. * Stop infusion of dexmedetomidine at 10 minutes before the end of surgery.

Treatment:

Drug: Assisted anesthesia

Drug: Anesthesia induction

Drug: Anesthesia maintenance

Dexmedetomidine B

Experimental group

Description:

* With a history of asthma * Infusion of dexmedetomidine(1μg/kg) at 10 minutes before anesthesia induction. * Infusion of dexmedetomidine at 0.7μg•kg-1•h-1during anesthesia maintenance. * Stop infusion of dexmedetomidine at 10 minutes before the end of surgery.

Treatment:

Drug: Assisted anesthesia

Drug: Anesthesia induction

Drug: Anesthesia maintenance

Control group

Placebo Comparator group

Description:

* With a history of asthma * Infusion of normal saline(1μg/kg) at 10 minutes before anesthesia induction. * Infusion of normal saline at 0.4μg•kg-1•h-1during anesthesia maintenance. * Stop infusion of normal saline at 10 minutes before the end of surgery.

Treatment:

Drug: Anesthesia induction

Drug: Anesthesia maintenance