D-FAB-POUR Trial: Dexmedetomidine vs Fentanyl as Adjuvants to Bupivacaine on Postoperative Urinary Retention
NCT07117565
Anesthesia, Spinal, Bupivacaine
Bhadrapur, Koshi, Nepal
View Trial DetailsNCT Number: NCT06638658
This study will focus on orthopedic surgery patients from high-altitude regions, utilizing smart wearables and monitoring tools to gather perioperative data, including heart rate, oxygen saturation, sleep quality, stress levels, and other relevant metrics. Regular follow-ups will assess recovery and complications, in addition to collecting medical records, lab results, imaging data, and other pertinent records. The ultimate goal is to establish a comprehensive follow-up cohort of orthopedic surgery patients from high-altitude areas.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Prolonged exposure to hypoxic and low-pressure environments leads to structural remodeling and functional abnormalities in the cardiovascular, respiratory, and hematological systems of high-altitude populations. This elevates the risk of postoperative complications, particularly in patients undergoing orthopedic surgery, significantly impacting their recovery and quality of life. This study will focus on orthopedic surgery patients from high-altitude regions. Using smart wearable devices and other monitoring tools, comprehensive perioperative dynamic data of participants, including heart rate, heart rate variability, oxygen saturation, respiratory rate, sleep quality, activity levels, stress index, and other relevant indicators will be collected. Regular follow-ups will be conducted to evaluate postoperative recovery and monitor the incidence of perioperative complications. Additionally, perioperative data such as electronic medical records, laboratory test results, ECG waveforms, echocardiography, chest CT images, and other pertinent records will be also collected. Through that, this study aims to establish a follow-up cohort of orthopedic surgery patients from high-altitude regions.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: During hospitalization
Defined according to the European Perioperative Clinical Outcome (EPCO) criteria, including both deep vein thrombosis and pulmonary embolism.
Time frame: Up to 2 weeks postoperatively
Defined according to the European Perioperative Clinical Outcome (EPCO) criteria, including both deep vein thrombosis and pulmonary embolism.
Time frame: During hospitalization
Defined according to the European Perioperative Clinical Outcome (EPCO) criteria, including respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, and aspiration pneumonia.
Time frame: During hospitalization
Defined according to the European Perioperative Clinical Outcome (EPCO) criteria, including non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure, new cardiac arrhythmias, angina, et al.
Time frame: During hospitalization
Nausea and vomiting
Time frame: During hospitalization
Assessed using QoR-15 score at different time points after surgery
Time frame: Up to 1 year postoperatively
Assessed using NRS scale and BPI at different time points after surgery
Time frame: Up to 1 year postoperatively
Assessed using WHODAS2.0 scores at different time points after surgery
Time frame: During hospitalization
Assessed using NRS scale and BPI at different time points after surgery
Time frame: During hospitalization
Using NRS scale and BPI at different time points after surgery
Time frame: During hospitalization
Defined according to the European Perioperative Clinical Outcome (EPCO) criteria
Time frame: During hospitalization
Defined as time to first defecation or flatus
Time frame: Up to 1 year postoperatively
Assessed using the Pittsburgh Sleep Quality Index (PSQI) and the Morningness-Eveningness Questionnaire (MEQ) at different time points after surgery
Time frame: Up to 1 year postoperatively
Assessed using GAD-7 scores at different time points after surgery
Time frame: Up to 1 year postoperatively
Assessed using PHQ-9 scores at different time points after surgery
Time frame: Up to 1 year postoperatively
Assessed using AD-8 and three-word recall test scores at different time points after surgery
Contact information is provided by the study sponsor or research team.
Chunling Jiang, PhD
CONTACT
Fengming Luo, phD
CONTACT
West China Hospital
Other
Postoperative Complications of Orthopedic Surgery in Patients From High-altitude Regions: a Cohort Study.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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