Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
223 participants
INTERVENTIONAL
2022-03-01
2024-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group BK
Group BK received esketamine infusion at a rate of 0.3 mg/kg/h during surgery. Patients were provided with patient-controlled intravenous analgesia (PCIA) containing esketamine (1.5 mg/kg), butorphanol (0.15 mg/kg), and azasetron (20 mg) in a total volume of 100 ml within 48 hours after surgery.
Esketamine
In the esketamine combined with butorphanol group (Group BK), patients received an intraoperative intravenous infusion of esketamine (0.3 mg/kg/h) followed by postoperative patient-controlled intravenous analgesia (PCIA) (esketamine 1.5 mg/kg + butorphanol 0.15 mg/kg + azasetron 20 mg).
Butorphanol
In the butorphanol group (Group B), patients received an equivalent volume of normal saline intraoperatively and postoperatively received PCIA without esketamine.
Group B
Group B received an equivalent volume of saline during surgery. Patients were provided with patient-controlled intravenous analgesia (PCIA) containing butorphanol (0.15 mg/kg), and azasetron (20 mg) in a total volume of 100 ml within 48 hours after surgery.
Butorphanol
In the butorphanol group (Group B), patients received an equivalent volume of normal saline intraoperatively and postoperatively received PCIA without esketamine.
Interventions
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Esketamine
In the esketamine combined with butorphanol group (Group BK), patients received an intraoperative intravenous infusion of esketamine (0.3 mg/kg/h) followed by postoperative patient-controlled intravenous analgesia (PCIA) (esketamine 1.5 mg/kg + butorphanol 0.15 mg/kg + azasetron 20 mg).
Butorphanol
In the butorphanol group (Group B), patients received an equivalent volume of normal saline intraoperatively and postoperatively received PCIA without esketamine.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Classified as American Society of Anesthesiologists I-III
* Undergoing video-assisted lobectomy
Exclusion Criteria
* Significant comorbidities affecting vital organs such as liver, kidney, and heart
* Severe infections
* Immunodeficiency
* Coagulation disorders
* History of analgesic drug abuse
* Severe dementia or communication barriers
* Mental illnesses.
20 Years
70 Years
ALL
No
Sponsors
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Tongji Hospital
OTHER
Second People's Hospital of Hefei City
OTHER
Responsible Party
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Wang Hongjian
Attending doctor
Principal Investigators
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Xianwen Hu, PhD
Role: STUDY_CHAIR
The Second Hospital of Anhui Medical University
Wensheng He, MD
Role: STUDY_DIRECTOR
The Second People's Hospital of Hefei
Xin Wang, MD
Role: PRINCIPAL_INVESTIGATOR
The Second People's Hospital of Hefei
Zicheng Wang, MD
Role: PRINCIPAL_INVESTIGATOR
The Second People's Hospital of Hefei
Junbao Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
The Second People's Hospital of Hefei
Locations
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The Second People's Hospital of Hefei
Hefei, Anhui, China
Countries
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References
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Wang H, Wang Z, Zhang J, Wang X, Fan B, He W, Hu X. Perioperative esketamine combined with butorphanol versus butorphanol alone for pain management following video-assisted lobectomy: a randomized controlled trial. Int J Clin Pharm. 2025 Apr;47(2):452-461. doi: 10.1007/s11096-024-01850-7. Epub 2025 Jan 3.
Other Identifiers
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2022-keyan-007
Identifier Type: -
Identifier Source: org_study_id
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