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

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

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.

Study Overview

• Status: Unknown
• Conditions: Adverse Effect
• Intervention / Treatment: Drug: dexmedetomidine; Other: normal saline

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Ningxia
    • Yinchuan, Ningxia, China, 750004
      • General Hospital of Ningxia Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of tumor necrosis factor-α before anesthesia 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).	Intraoperative and immediately after surgery
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
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

Collaborators and Investigators

• Sponsor: General Hospital of Ningxia Medical University
• Investigators: Principal Investigator: Li Na, General Hospital of Ningxia Medical University

Publications and helpful links

General Publications

• 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. 2022 Sep 27. doi: 10.1007/s11325-022-02711-1. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2018
• Primary Completion (Anticipated): April 30, 2019
• Study Completion (Anticipated): April 30, 2019

Study Registration Dates

• First Submitted: June 19, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): August 2, 2018
• Last Update Submitted That Met QC Criteria: August 1, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: dexmedetomidine; inflammatory factors; oxygenation index; respiratory index
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: MHX07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: safety

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No