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

Adverse Effect Clinical Trial

Official title:

Effects of Dexmedetomidine on Oxygenation Index, Respiratory Index and Inflammatory Factors in Patients Undergoing Palatopalatyngoplasty

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03612440
• Other study ID #: MHX07
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: August 2018
• Source: General Hospital of Ningxia Medical University
• Contact: Ma Hanxiang
• Phone: +86-13519591508
• Email: mahanxiang[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients undergoing palatopalatyngoplasty

• ASA physical status II-III

• Aged 18-65 years

• BMI 18.5-30kg/m2

Exclusion Criteria:

• Bradycardia

• Atrioventricular block

• Allergic to the drugs

• Complicating pulmonary disease(including pulmonary infection,COPD, asthma and so on)

Related Conditions & MeSH terms

• Adverse Effect

Intervention

Drug:
• dexmedetomidine
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

Other:
• normal saline
receive matching placebo (equal volum of normal saline)

Locations

Country	Name	City	State
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Ningxia Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Oxygenation Index	Arterial blood samples were sampled before anaesthesia induction and immediately after surgery for the oxygenation index by using blood gas analyzer.	Intraoperative and immediately after surgery
Primary	The Respiratory Index	Arterial blood samples were sampled before anaesthesia induction and immediately after surgery for the respiratory index by using blood gas analyzer.	Intraoperative and immediately after surgery
Secondary	Change of tumor necrosis factor-a before anesthesia and immediately after surgery	Blood samples were sampled before anaesthesia induction and immediately after surgery for the serum tumor necrosis factor-a,which were analyzed by using enzyme linked immunosorbent assay (ELISA).	Intraoperative and immediately after surgery
Secondary	Change of interleukin-6 before anesthesia 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).	Intraoperative and immediately after surgery
Secondary	Change of interleukin-10 before anesthesia 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).	Intraoperative and immediately after surgery