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Injection of dexmedetomidine into the paravertebral space (where the nerve for the chest section comes out of the vertebra) protects against lung injury during lung surgery when only one lung is being inflated by a breathing machine

Paravertebral dexmedetomidine as an adjuvant to ropivacaine protects against lung injury in the non-ventilated lung during one-lung ventilation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13000406
Enrollment
120
Registered
2018-05-21
Start date
2016-07-01
Completion date
Unknown
Last updated
2019-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute lung injury following selective radical resection for pulmonary carcinoma Respiratory Acute lung injury

Interventions

In total, 120 patients who underwent elective radical resection of pulmonary carcinoma were randomly assigned to one of six groups (n=20): normal saline (C group), ropivacaine (R group), intravenous d
patients in the R group received a total volume of 20 ml 0.5% ropivacaine for the TPVB (cat No. NATM, AstraZeneca, Sweden), with 10 ml injected at each puncture point
patients in the Div group received a total dosage of 0.5 µg/kg intravenous dexmedetomidine (cat No. 20160301, Jiangsu Nhwa Pharmaceutical Co., Ltd, China) over 10 min
and patients in the RD0.5, RD1.0 and RD2.0 groups received ropivacaine (final concentration of 0.5%) mixed with 0.5 µg/kg, 1.0 µg/kg and 2.0 µg/kg dexmedetomidine, respectively, as an adjuvant. Only o

Sponsors

Henan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. American Society of Anesthesiologists (ASA) physician status I or II 2. Aged 18-65 years 3. Scheduled for selective radical resection of pulmonary carcinoma

Exclusion criteria

Exclusion criteria: 1. Hypertension 2. Diabetes mellitus 3. Heart diseases 4. Suggestive history of inflammation or coagulation dysfunction

Design outcomes

Primary

MeasureTime frame
Lung injury score. Method: The histological changes of the fixed lung tissue were evaluated by an independent pathologist who was blinded to the study protocols. The lung tissues were embedded in paraffin wax, sectioned (5 µm), and then stained with hematoxylin and eosin. The severity of lung injury was quantified using the 4-point scoring system, which included pulmonary interstitial edema, alveolar edema, alveolar congestion and neutrophil infiltration. Scoring standards were as follows: 0, no change or very mild changes; 1, mild changes; 2, moderate changes; and 3, severe changes. The average lung injury score from three adjacent slices was evaluated. The summation of four scores was recognized as the final lung injury score. Time point: Immediately after the tumor tissue was excised

Secondary

MeasureTime frame
1. Hemodynamics (heart rate, mean arterial pressure) measured using the ECG monitor and invasive arterial pressure system. Time points: preoperative (Pre) - 15 min after admission to the operating room without any drug treatment, two-lung ventilation (TLV) - immediately before initiation of one-lung ventilation (OLV), OLV1 - 15 min after initiation of OLV, OLV2 - 30 min after initiation of OLV, OLV3 - immediately before the tumor tissue was excised 2. Apoptosis measured using a TUNEL assay employed according to the manufacturer’s protocol of an in situ cell death detection kit-POD (cat no. 11684817910; Roche, Basel, Switzerland). Apoptotic cells were indicated by brown-yellow granules in the cytoplasm. The number of apoptotic cells in random fields of view (magnification, x400) was calculated. The apoptosis index (AI; %) was expressed as follows: the number of apoptotic cells/the total number of cells x100. The slides were prepared immediately after tumor excision. 3. Inflammatory cytokines measured by enzyme-linked immunosorbent assay (ELISA). Lung tissues were prepared as 10% tissue homogenates and centrifuged at 3000 rpm at 4°C for 10 min. The supernatant was collected for further analysis. The concentrations of TNF-a and IL-6 in lung tissues were measured according to the manufacturer’s instructions using ELISA kits (Nanjing Keygen Biotech Co., Ltd.). Absorbance at 450 nm (OD 450) was determined using a microplate reader. The tissues were prepared immediately after tumor excision.

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026