NCT03612440

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

August 2, 2018

Status Verified

August 1, 2018

Enrollment Period

9 months

First QC Date

June 19, 2018

Last Update Submit

August 1, 2018

Conditions

Adverse Effect

Keywords

dexmedetomidineoxygenation indexrespiratory indexinflammatory factors

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Change of tumor necrosis factor-α before anesthesia and immediately after surgery

    Intraoperative and immediately after surgery

  • Change of interleukin-6 before anesthesia and immediately after surgery

    Intraoperative and immediately after surgery

  • Change of interleukin-10 before anesthesia and immediately after surgery

    Intraoperative and immediately after surgery

Study Arms (2)

Group D

EXPERIMENTAL

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

Group C

PLACEBO COMPARATOR

40 patients receive matching placebo (normal saline)

Other: normal saline

Interventions

dexmedetomidineDRUG

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 D
normal salineOTHER

receive matching placebo (equal volum of normal saline)

Group C

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

Related Publications (1)

  • 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.

    PMID: 36166132DERIVED

MeSH Terms

Interventions

DexmedetomidineSaline Solution

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Li Na

    General Hospital of Ningxia Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ma Hanxiang

CONTACT

+86-13519591508mahanxiang@hotmail.com

Li Na

CONTACT

+86-13629517998

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2018

First Posted

August 2, 2018

Study Start

August 1, 2018

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

August 2, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

safety

Locations

CN(1)