Effects of Dexmedetomidine on OI, RI and Inflammatory Factors in Patients Undergoing Palatopalatyngoplasty.

Not Applicable

• Conditions: Adverse Effect
• Interventions: Other: normal saline; Drug: dexmedetomidine

• Registration Number: NCT03612440
• Lead Sponsor: General Hospital of Ningxia Medical University

Brief Summary

The purpose of this study is to investigate the efficacy of dexmedetomidine on oxygenation index, respiratory index and inflammatory factors, and to explore the protective effect of the dexmedetomidine on respiratory function in patients undergoing palatopalatyngoplasty.

Detailed Description

Obstructive sleep apnea syndrome is common among people, especially among obese people, Which is characterized by periodic or complete upper airway obstruction and hypoxia during sleep. Intermittent hypoxia contributes to the lung damage by increased oxidative stress, inflammation. Some researchers suggested that dexmedetomidine can inhibit inflammatory reaction and lessen the damage of respiratory function. The aim of this study is to investigate the efficacy of dexmedetomidine on oxygenation index, respiratory index and inflammatory factors, and to explore the protective effect of the dexmedetomidine on respiratory function in patients undergoing palatopalatyngoplasty.

Study Timeline

• Study First Submitted: 2018-06-19
• Status Verified: 2018-08
• Study Start: 2018-08-01
• Study First Submitted QC: 2018-08-01
• Last Update Submitted: 2018-08-01
• Study First Posted: 2018-08-02
• Last Update Posted: 2018-08-02
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients undergoing palatopalatyngoplasty
• ASA physical status II-III
• Aged 18-65 years
• BMI 18.5-30kg/m2

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Exclusion Criteria

• Bradycardia
• Atrioventricular block
• Allergic to the drugs
• Complicating pulmonary disease(including pulmonary infection,COPD, asthma and so on)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	normal saline	40 patients receive matching placebo (normal saline)
Group D	dexmedetomidine	40 patients receive a loading infusion of dexmedetomidine (1ug/kg)for 20min follow by a maintenance infusion (0.4ug/kg/h) continued until the end of the surgery

Primary Outcome Measures

Name	Time	Method
The Respiratory Index	Intraoperative and immediately after surgery	Arterial blood samples were sampled before anaesthesia induction and immediately after surgery for the respiratory index by using blood gas analyzer.
The Oxygenation Index	Intraoperative and immediately after surgery	Arterial blood samples were sampled before anaesthesia induction and immediately after surgery for the oxygenation index by using blood gas analyzer.

Secondary Outcome Measures

Name	Time	Method
Change of tumor necrosis factor-α before anesthesia and immediately after surgery	Intraoperative and immediately after surgery	Blood samples were sampled before anaesthesia induction and immediately after surgery for the serum tumor necrosis factor-α，which were analyzed by using enzyme linked immunosorbent assay (ELISA).
Change of interleukin-6 before anesthesia and immediately after surgery	Intraoperative and immediately after surgery	Blood samples were sampled before anaesthesia induction and immediately after surgery for the serum interleukin-6, which were analyzed by using enzyme linked immunosorbent assay (ELISA).
Change of interleukin-10 before anesthesia and immediately after surgery	Intraoperative and immediately after surgery	Blood samples were sampled before anaesthesia induction and immediately after surgery for the serum interleukin-10, which were analyzed by using enzyme linked immunosorbent assay (ELISA).

Trial Locations

Locations (1)

General Hospital of Ningxia Medical University; 🇨🇳 Yinchuan, Ningxia, China