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Intraoperative inspired oxygen fraction and dexmedetomidine for postoperative pulmonary complications in frail patients undergoing major abdominal surgery: A 2 × 2 Factorial, Blinded, Randomized Trial

Intraoperative inspired oxygen fraction and dexmedetomidine for postoperative pulmonary complications in frail patients undergoing major abdominal surgery: A 2 × 2 Factorial, Blinded, Randomized Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096839
Enrollment
Unknown
Registered
2025-02-07
Start date
2025-02-12
Completion date
Unknown
Last updated
2025-02-10

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

Conditions

postoperative pulmonary complications

Interventions

Control :A loading dose of saline was pumped for 10 min before induction of anesthesia (at a rate equivalent to dexmedetomidine 0.6 µg/kg), and after the loading dose, saline was continuously infused
A:A loading dose of saline was pumped for 10 min before induction of anesthesia (at a rate equivalent to dexmedetomidine 0.6 µg/kg), and after the loading dose, saline was continuously infused (at a r
B:A loading dose of dexmedetomidine 0.6 µg/kg was pumped for 10 min before induction of anesthesia, and dexmedetomidine 0.5 µg/kg/h was continuously infused after the loading dose, and the input was s
AB:A loading dose of dexmedetomidine 0.6 µg/kg was pumped for 10 min before induction of anesthesia, and dexmedetomidine 0.5 µg/kg/h was continuously infused after the loading dose, and the input was

Sponsors

The Fourth Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Age > 50 years; 2. Undergoing elective abdominal surgery with an expected operative time > 2 hours; 3. Modified Frailty Index (mFI) >= 0.21.

Exclusion criteria

Exclusion criteria: 1. ASA > ?; 2. Body mass index (BMI) over 30 kg/m2; 3. Those who are already undergoing mechanical ventilation before surgery; 4. Allergic to dexmedetomidine; 5. Sick sinus syndrome, or severe sinus bradycardia (< 50 beats/minute), or second degree or higher atrioventricular block; 6. Preoperative inability to communicate due to language barriers, mental disorders, and so on; 7. Have already been enrolled in this study; 8. Refused to participate.

Design outcomes

Primary

MeasureTime frame
Incidence of pulmonary complications within 7 days after surgery;

Secondary

MeasureTime frame
Time to postoperative pulmonary complications;ICU admissions;ICU hours;Length of postoperative hospitalization;Composite complication index within 7 days after surgery;Incidence of single or pulmonary complications within 30 days of surgery;Incidence of multiple pulmonary complications within 30 days of surgery;Incidence of extrapulmonary complications within 30 days after surgery;Composite complication index within 30 days after surgery;All-cause mortality within 30 days of surgery;

Countries

China

Contacts

Public ContactHuiqun Jia

The Fourth Hospital of Hebei Medical University

jysyjiahuiqun@163.com+86 139 0321 1399

Outcome results

None listed

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