Regional Anesthesia and Endometrial Cancer Recurrence

• Status: Withdrawn
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine whether recurrence of local and metastatic cancer after open hysterectomy for stage 1 or 2 endometrial cancer is reduced when patients receive epidural anesthesia/analgesia combined with propofol sedation rather than sevoflurane anesthesia and opioid analgesia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Treatments: Anesthetics; Propofol; Sevoflurane

Criteria

Inclusion Criteria:

1. Primary endometrial cancer without known extension beyond the uterus i.e., believed to be Stage 1 or 2

2. Scheduled for open abdominal hysterectomy

3. Written informed consent, including willingness to be randomized epidural anesthesia/analgesia with sedation or to sevoflurane general anesthesia and postoperative opioid analgesia

Exclusion Criteria:

1. Previous surgery for endometrial cancer

2. Any contraindication to epidural anesthesia or analgesia (including coagulopathy, abnormal anatomy)

3. Any contraindication to midazolam, propofol, sevoflurane, fentanyl, or morphine

4. Age < 18 or > 85 years old

5. ASA Physical Status ≥ 4

6. Any contraindication to epidural anesthesia and analgesia (including coagulopathy, abnormal anatomy)

7. Other cancer not believed by the attending surgeon to be in long-term remission

8. Systemic disease believed by the attending surgeon or anesthesiologist to present ≥ 25% two-year mortality