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

Sponsor

General Hospital of Ningxia Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03612440

Collaborator

(none)

Enrollment

Location

Arms

8.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adverse Effect	Drug: dexmedetomidine Other: normal saline	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2018

Anticipated Primary Completion Date :

Apr 30, 2019

Anticipated Study Completion Date :

Apr 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group D 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	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
Placebo Comparator: Group C 40 patients receive matching placebo (normal saline)	Other: normal saline receive matching placebo (equal volum of normal saline)

Arm

Intervention/Treatment

Experimental: Group D

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

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

Placebo Comparator: Group C

40 patients receive matching placebo (normal saline)

Other: normal saline

receive matching placebo (equal volum of normal saline)

Outcome Measures

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

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

Sponsors and Collaborators

General Hospital of Ningxia Medical University

Investigators

Principal Investigator: Li Na, 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:

NCT03612440

Other Study ID Numbers:

MHX07

First Posted:

Aug 2, 2018

Last Update Posted:

Aug 2, 2018

Last Verified:

Aug 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by General Hospital of Ningxia Medical University

Additional relevant MeSH terms:

Dexmedetomidine

Study Results

No Results Posted as of Aug 2, 2018