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

NCT ID: NCT03612440

Last Updated: 2018-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2019-04-30

Brief Summary

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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

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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.

Conditions

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Adverse Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type EXPERIMENTAL

dexmedetomidine

Intervention Type DRUG

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

Group C

40 patients receive matching placebo (normal saline)

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type OTHER

receive matching placebo (equal volum of normal saline)

Interventions

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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

Intervention Type DRUG

normal saline

receive matching placebo (equal volum of normal saline)

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General Hospital of Ningxia Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Li Na

Role: PRINCIPAL_INVESTIGATOR

General Hospital of Ningxia Medical University

Locations

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General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Site Status

Countries

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China

Central Contacts

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Ma Hanxiang

Role: CONTACT

+86-13519591508

Li Na

Role: CONTACT

+86-13629517998

References

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Li N, Zhang Y, Yang F, Zhang H, Yu X, Lu K, Wang J, Ma H, Ni X. Effects of dexmedetomidine on oxygenation and inflammatory factors in patients undergoing uvulopalatopharyngoplasty: a prospective, randomized, placebo-controlled trial. Sleep Breath. 2023 Jun;27(3):1099-1106. doi: 10.1007/s11325-022-02711-1. Epub 2022 Sep 27.

Reference Type DERIVED
PMID: 36166132 (View on PubMed)

Other Identifiers

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MHX07

Identifier Type: -

Identifier Source: org_study_id

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