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Sponsored by: |
Outcomes Research Consortium |
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Information provided by: | Outcomes Research Consortium |
ClinicalTrials.gov Identifier: | NCT00531349 |
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.
Condition | Intervention | Phase |
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Cancer |
Procedure: propofol general anesthesia Drug: Sevoflurane |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Regional Anesthesia and Endometrial Cancer Recurrence |
Enrollment: | 0 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | February 2013 |
Estimated Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
General anesthesia and opioid analgesia for the treatment of pain after surgery.
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Drug: Sevoflurane
General anesthesia
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B: Active Comparator
Regional anesthesia and analgesia, (epidural), combined with deep sedation or general anesthesia.
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Procedure: propofol general anesthesia
Regional analgesia combined with sedation or a propofol general anesthesia
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This is a Phase III, multi-center study of patients having open hysterectomies for endometrial cancer. Patients will be randomly assigned to 1) epidural anesthesia/analgesia with propofol sedation; or, 2) general anesthesia combined with postoperative patient-controlled morphine analgesia. A total (maximum) of 1700 patients enrolled over a 5 year enrollment.
All patients will be premedicated with 1-3 mg IV midazolam and 1-2 µg/kg fentanyl. Patients will be randomly assigned to epidural anesthesia & analgesia with propofol sedation or to sevoflurane general anesthesia and postoperative opioid analgesia after they have met the inclusion/exclusion criteria and consent to the study.
In patients assigned to general anesthesia and opioid analgesia (General Anesthesia Group), general anesthesia will be induced with 1-3 µg/kg fentanyl and 2-4 mg/kg propofol. Tracheal intubation will be facilitated by succinylcholine or a non-depolarizing muscle relaxant; alternatively, a supraglottic airway (such as a laryngeal mask) will be used. Additional non-depolarizing muscle relaxant will be administered as deemed necessary by the attending anesthesiologist.
Anesthesia will be maintained with sevoflurane in 80% oxygen, balance nitrogen, and fentanyl. Sevoflurane and fentanyl administration will be adjusted to maintain blood pressure and heart rate within 20% of pre-operative values. The lungs will be mechanically ventilated to maintain end-tidal PCO2 near 35 mmHg. When surgery is complete, muscle relaxant will be antagonized, if necessary, and the trachea extubated. Post-operative analgesia will be morphine, provided as needed IV or via patient-controlled pump. The initial pump setting will be for 1-mg boluses with a 6-minute lockout period and no background infusion. Additional morphine will be provided as necessary to maintain good pain control, either as needed or by changing the pump settings. Morphine will be the first-line drug; but hydromorphone will be substituted at one-fifth the morphine dose in patients who do not tolerate morphine. When pain is adequately controlled without much morphine (usually on the second postoperative day), patients will be transitioned to acetaminophen and non-steroidal anti-inflammatory analgesics; oral opioids will also be permitted if necessary.
In the Epidural Anesthesia and Analgesia group, a T8-10 epidural catheter will be inserted using a standard technique. After negative aspiration for blood, patients will be given a test dose of 3 ml of 1.5% lidocaine and 1:200,000 epinephrine. The catheter will be re-inserted or repositioned as necessary until both aspiration and test dose are negative. Each patient will be given an additional 12-18-ml bolus of 0.5% bupivacaine or 0.5% ropivacaine to provide intraoperative analgesia. The catheter will be repositioned or reinserted as necessary if a sensory block to temperature cannot be confirmed in the surgical dermatomes. Additional 5-10 ml boluses of the same solution will be given hourly during surgery to maintain anesthesia; additional boluses will be permitted at the discretion of the attending anesthesiologist.
Postoperative epidural analgesia will be supplemented with acetaminophen and/or NSAIDs if needed, or per individual sites' routine protocol. Supplemental morphine will be provided only if pain relief is inadequate, either "as needed" or by patient-controlled infusion. As soon as practical, usually on the second postoperative day, patients will be transitioned to acetaminophen and/or non-steroidal analgesics and, if necessary, oral opioids.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Ohio | |
Cleveland Clinic | |
Cleveland, Ohio, United States, 44129 |
Principal Investigator: | Daniel I Sessler, MD | Cleveland Clinic |
Study Chair: | Daniel I Sessler, MD | Cleveland Clinic |
Responsible Party: | Cleveland Clinic ( Daniel I. Sessler, MD ) |
Study ID Numbers: | 07-532 |
Study First Received: | September 17, 2007 |
Last Updated: | April 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00531349 |
Health Authority: | United States: Institutional Review Board |
Endometrial Cancer Anesthesia; regional cancer recurrence Analgesia; opioid |
Genital Diseases, Female Endometrial Neoplasms Genital Neoplasms, Female Uterine Diseases Uterine Neoplasms |
Urogenital Neoplasms Endometrial cancer Propofol Recurrence Sevoflurane |
Anesthetics, Intravenous Disease Attributes Hematologic Agents Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Pharmacologic Actions Anesthetics, Inhalation |
Neoplasms Pathologic Processes Neoplasms by Site Anesthetics, General Therapeutic Uses Hypnotics and Sedatives Platelet Aggregation Inhibitors Central Nervous System Agents |