Clinical trial NCT05334251: General Anesthesia or Combined Spinal-epidural Anesthesia With Ketofol Sedation in Colon Cancer Surgery?
Official title: General Anesthesia or Combined Spinal-epidural Anesthesia With Ketofol Sedation in Colon Cancer Surgery?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colon Cancer
Anesthesia
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2022-04-19
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 40 years of age who are scheduled for open surgery with a diagnosis of colon cancer.

Brief summary: Anesthesia management in colon cancer surgery affects the postoperative mobilization, discharge and oral intake times of the patients. Due to the side effects of opioids, their use is tried to be reduced and therefore regional anesthesia methods are preferred in suitable patients. Especially in the preoperative period, opioid use has a negative effect on the recovery processes, morbidity and mortality of the patients. Epidural analgesia, a central block method, is recommended for postoperative pain control in ERAS protocols. Opioids suppress cellular and humoral immunity. Epidural analgesia reduces both opioid consumption and surgical stress response. It has been shown that epidural analgesia maintains the immune functions of patients and is associated with a decrease in tumor recurrence. It has also been shown to reduce postoperative pain, hypercoagulability and pulmonary complications, increase exercise capacity and accelerate the return of intestinal functions to normal. In line with this information, in this study, it was aimed to investigate the differences in the postoperative period in patients managed with regional anesthesia.

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.


Eligibility criteria: Inclusion Criteria:

* Patients over 40 years of age who are scheduled for open surgery with a diagnosis of colon cancer

Exclusion Criteria:

* Local anesthetic allergy
* Patients scheduled for laparoscopic surgery

Primary outcomes:
measure: visual analog scale (VAS)
timeFrame: postoperative 2nd hour.
measure: visual analog scale (VAS)
timeFrame: postoperative 4th hour.
measure: visual analog scale (VAS)
timeFrame: postoperative 8th hour.
measure: visual analog scale (VAS)
timeFrame: postoperative 12th hour.
measure: visual analog scale (VAS)
timeFrame: postoperative16th hour.
measure: visual analog scale (VAS)
timeFrame: postoperative 24th hour.
measure: time to start oral intake
timeFrame: to be observed until the start of oral intake after the operation. it will be assessed up to 720 hours.
measure: mobilization time
timeFrame: to be observed until the start of walking after the operation. it will be assessed up to 720 hours.
measure: urinary catheter withdrawal time
timeFrame: to be observed until the withdrawal of urinary catheter after the operation. it will be assessed up to 720 hours.
measure: hospitalization time
timeFrame: from hospitalization for the operation to the day of discharge, it will be assessed up to 30 days.
measure: nasogastric withdrawal time
timeFrame: to be observed until the withdrawal of nasogastric tube after the operation. it will be assessed up to 720 hours.
measure: drain removal time
timeFrame: to be observed until the withdrawal of abdominal drain after the operation. it will be assessed up to 720 hours.
measure: complications
timeFrame: to be observed for 30 days postoperatively.
measure: blood pressure
timeFrame: preoperatively
measure: blood pressure
timeFrame: perioperatively. "30 minutes" will be taken as the measurement period.
measure: FiCO2
timeFrame: preoperatively
measure: FiCO2
timeFrame: perioperatively. "30 minutes" will be taken as the measurement period.
measure: sPO2
timeFrame: preoperatively
measure: sPO2
timeFrame: perioperatively. "30 minutes" will be taken as the measurement period.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.