Dexmedetomidine Dose-Dependent on Lung Function and AQP1 in One-Lung Ventilation Surgery

NCT07145814 | Completed

• 1 other identifier: 2016NXSYYEC-007
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial evaluated the dose-dependent effects of dexmedetomidine (DEX) on pulmonary function and aquaporin-1 (AQP1) expression during one-lung ventilation (OLV) in thoracoscopic surgery.

Conditions

Acute Lung Injury(ALI)

Keywords

Dexmedetomidine; Aquaporins; Lung Function; One-lung ventilation

Outcome Measures

Primary Outcomes (1)

• aquaporin-1 (AQP1) expression during one-lung ventilation in thoracoscopic surgery

  AQP1 expression, serving as an indicator of pulmonary interstitial water permeability, was assessed by immunohistochemistry (IHC) on lung tissue samples. Two histologically normal specimens (1×1×1 cm³ each) were collected per patient: 1) Before one-lung ventilation: ≥ 5 cm from tumor margin in planned resection area; 2) Immediately after lobectomy: ≥ 5 cm from margin in isolated lung. Tissues were fixed in 10% neutral buffered formalin (24 hours), paraffin-embedded, and sectioned (3 μm). Five random high-power fields (HPF, 400x) per section were evaluated. The percentage of positive cells (0: 0-25%; 1: 26-50%; 2: 51-75%; 3: 76-100%) and staining intensity (0: none; 1: light yellow; 2: brown; 3: dark brown) were scored. The total IHC score (range 0-9) was calculated as (percentage score x intensity score); specimens were classified as low (≤ 4) or high (\> 4) AQP1 expression.

  before one-lung ventilation, Immediately after lobectomy

Secondary Outcomes (2)

• Pulmonary function during one-lung ventilation in thoracoscopic surgery, including lung compliance (Cdyn)

  pre-dexmedetomidine administration, 60 minutes, 90 minutes, 120 minutes after one-lung ventilation initiation, and 30 minutes after reinstitution of two-lung ventilation

• Pulmonary function during one-lung ventilation in thoracoscopic surgery, including respiratory index (RI), and oxygenation index (OI).

  pre-dexmedetomidine administration, 60 minutes, 90 minutes, 120 minutes after one-lung ventilation initiation, and 30 minutes after reinstitution of two-lung ventilation

Study Arms (3)

Placebo group

PLACEBO COMPARATOR

Placebo group received an equivalent volume of 0.9% saline.

Drug: 0.9 % saline

dexmedetomidine Low Dose group

EXPERIMENTAL

Following Anesthesia induction, dexmedetomidine (DEX) Low Dose group received a DEX loading dose (0.5 µg/kg over 10 min), followed by continuous infusions of 0.3 µg/kg/h, respectively, until 30 minutes before the end of the operation.

Drug: dexmedetomidine 0.3 µg/kg/h

dexmedetomidine high dose group

EXPERIMENTAL

Following Anesthesia induction, dexmedetomidine (DEX) high dose group received a DEX loading dose (0.5 µg/kg over 10 min), followed by continuous infusions of 0.5 µg/kg/h, respectively, until 30 minutes before the end of the operation.

Drug: dexmedetomidine 0.5 µg/kg/h

Interventions

dexmedetomidine 0.3 µg/kg/h DRUG

Following Anesthesia induction, dexmedetomidine (DEX) Low Dose group received a DEX loading dose (0.5 µg/kg over 10 min), followed by continuous infusions of 0.3 µg/kg/h, respectively, until 30 minutes before the end of the operation.

dexmedetomidine Low Dose group

dexmedetomidine 0.5 µg/kg/h DRUG

Following Anesthesia induction, dexmedetomidine (DEX) high dose group received a DEX loading dose (0.5 µg/kg over 10 min), followed by continuous infusions of 0.5 µg/kg/h, respectively, until 30 minutes before the end of the operation.

dexmedetomidine high dose group

0.9 % saline DRUG

Placebo group received an equivalent volume of 0.9% saline.

Placebo group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I or II
• Age 40-70 years
• Body mass index (BMI) 18-30 kg/m²

You may not qualify if:

• Preoperative tumor radiotherapy or chemotherapy
• Immune or endocrine disorders
• Hepatic or renal dysfunction
• Preoperative corticosteroid use
• Recent respiratory infection or chronic lung disease
• Sick sinus syndrome or atrioventricular block
• Preoperative anemia (hemoglobin \< 90 g/L)

Sponsors & Collaborators

• People's Hospital of Guangxi Zhuang Autonomous Region: lead

Study Sites (1)

Department of Anesthesiology, Nanxishan Hospital of Guangxi Zhuang Autonomous Region

Guilin, Guangxi, 541002, China

Location

MeSH Terms

Conditions

Acute Lung Injury

Interventions

Dexmedetomidine; Sodium Chloride

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 28, 2025
• Study Start: January 5, 2018
• Primary Completion: March 29, 2019
• Study Completion: March 29, 2019
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)