General Anesthesia or Combined Spinal-epidural Anesthesia With Ketofol Sedation in Colon Cancer Surgery?
NCT ID: NCT05334251
Last Updated: 2022-04-19
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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UNKNOWN
60 participants
OBSERVATIONAL
2022-04-30
2023-04-30
Brief Summary
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In the study, it was planned to create two groups who underwent open surgery for colon cancer. The first group will be operated under general anesthesia and the second group will be operated under combined spinal-epidural anesthesia with ketofol sedation. An epidural catheter will be inserted in both groups for postoperative pain management. In the study, patients' age, gender, weight, comorbidity, ASA score, amount of local anesthetic used, postoperative VAS scores, mobilization time, time to start oral intake, nasogastric withdrawal time, drain removal time, urinary catheter withdrawal time, hospitalization time and total cost will be evaluated.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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general anesthesia group
Patients in this group will undergo open colon cancer surgery under general anesthesia. Epidural catheterization will be applied for postoperative analgesia.
No interventions assigned to this group
combined spinal-epidural anesthesia group
Patients in this group will undergo open colon cancer surgery under combined spinal-epidural anesthesia with ketofol sedation. Epidural catheterization will be applied for postoperative analgesia.
combined spinal-epidural anesthesia
Combined spinal and epidural anaesthesia is a regional anaesthetic technique, which combines the benefits of both spinal anaesthesia and epidural anaesthesia and analgesia. The spinal component gives a rapid onset of a predictable block. The indwelling epidural catheter gives the ability to provide long lasting analgesia and to titrate the dose given to the desired effect.
Interventions
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combined spinal-epidural anesthesia
Combined spinal and epidural anaesthesia is a regional anaesthetic technique, which combines the benefits of both spinal anaesthesia and epidural anaesthesia and analgesia. The spinal component gives a rapid onset of a predictable block. The indwelling epidural catheter gives the ability to provide long lasting analgesia and to titrate the dose given to the desired effect.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients scheduled for laparoscopic surgery
40 Years
ALL
No
Sponsors
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Ankara City Hospital Bilkent
OTHER
Responsible Party
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Ayça Özcan
Associate Professor, MD
Central Contacts
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References
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Wu HL, Tai YH, Mandell MS, Tsou MY, Yang SH, Chen TH, Chang KY. Effect of epidural analgesia on cancer prognosis after colon cancer resection: a single-centre cohort study in Taiwan. BMJ Open. 2020 Oct 22;10(10):e036577. doi: 10.1136/bmjopen-2019-036577.
Cummings KC III, Zimmerman NM, Maheshwari K, Cooper GS, Cummings LC. Epidural compared with non-epidural analgesia and cardiopulmonary complications after colectomy: A retrospective cohort study of 20,880 patients using a national quality database. J Clin Anesth. 2018 Jun;47:12-18. doi: 10.1016/j.jclinane.2018.03.005. Epub 2018 Mar 12.
Ljungqvist O, Hubner M. Enhanced recovery after surgery-ERAS-principles, practice and feasibility in the elderly. Aging Clin Exp Res. 2018 Mar;30(3):249-252. doi: 10.1007/s40520-018-0905-1. Epub 2018 Feb 16.
Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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E2-21-1021
Identifier Type: -
Identifier Source: org_study_id
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