Study on postoperative analgesia and delirium after lung surgery

UMIN ID: UMIN000042393

Registered date:09/11/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Thoracoscopic and thoracotomy pulmonary resection, partial lung resection
• Date of first enrollment: 2020/11/10
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

1) Desflurane + ESP (D-ESP) group After general anesthesia is introduced, the surgical position (lateral position) is taken, and then an ESP block is performed under ultrasound guidance (0.25% levobupivacaine 20 ml). Place a catheter under the erector spinae muscles and start intermittent administration (0.25% levobupivacaine). The catheter is removed in the morning 3 days after surgery. During surgery, desflurane and remifentanil are used to maintain anesthesia.
2) Desflurane + epidural block (D-Epi) group An epidural catheter is placed in the upper chest before the introduction of general anesthesia, and continuous administration is started at the same time as the start of surgery. (0.25% levobupivacaine 4ml / hr) The catheter is removed in the morning 3 days after surgery. During surgery, desflurane and remifentanil are used to maintain anesthesia.
3) Remimazolam + ESP (R-ESP) group After general anesthesia is introduced, the surgical position (lateral position) is taken, and then an ESP block is performed under ultrasound guidance (0.25% levobupivacaine 20 ml). Place a catheter under the erector spinae muscles and start intermittent administration (0.25% levobupivacaine). The catheter is removed in the morning 3 days after surgery. During surgery, anesthesia is maintained with remimazolam and remifentanil.
4) Remimazolam + epidural block (R-Epi) group An epidural catheter is placed in the upper chest before the introduction of general anesthesia, and continuous administration is started at the same time as the start of surgery. (0.25% levobupivacaine 4ml / hr) The catheter is removed in the morning 3 days after surgery. During surgery, anesthesia is maintained with remimazolam and remifentanil.

Outcome(s)

• Primary Outcome: postoperative rest, pain assessment during movement (VAS), time to use additional analgesics after awakening, frequency of use, postoperative delirium
• Secondary Outcome: postoperative nausea, vomiting, side effects

Key inclusion & exclusion criteria

• Age minimum: 40years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Exclude cases that apply to any one of the following 1) ASA classification > 4 2) Patients with a history of hypersensitivity to the drugs used in this study 3) Patients who are judged to be inappropriate by the doctor responsible for the medical institution conducting the research

Related Information

• Primary Sponsor: Akita University
• Source(s) of Monetary Support: Akita University