General Anesthesia or Combined Spinal-epidural Anesthesia With Ketofol Sedation in Colon Cancer Surgery?

Study Overview
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Brief Summary
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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.

Official Title
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General Anesthesia or Combined Spinal-epidural Anesthesia With Ketofol Sedation in Colon Cancer Surgery?

Conditions
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Colon Cancer, Anesthesia

Intervention / Treatment
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* Other: combined spinal-epidural anesthesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| general anesthesia group<br>Patients in this group will undergo open colon cancer surgery under general anesthesia. Epidural catheterization will be applied for postoperative analgesia. | |
| combined spinal-epidural anesthesia group<br>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. | Other: combined spinal-epidural anesthesia<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analog scale (VAS) | A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 5 cm horizontal line (between 0 and 5 points, 0 meaning 'no pain' and 5 meaning the worst) and this rating is then measured from the left edge (=Visual Analog Scale score). | postoperative 2nd hour. | 
| visual analog scale (VAS) | A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 5 cm horizontal line (between 0 and 5 points, 0 meaning 'no pain' and 5 meaning the worst) and this rating is then measured from the left edge (=Visual Analog Scale score). | postoperative 4th hour. | 
| visual analog scale (VAS) | A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 5 cm horizontal line (between 0 and 5 points, 0 meaning 'no pain' and 5 meaning the worst) and this rating is then measured from the left edge (=Visual Analog Scale score). | postoperative 8th hour. | 
| visual analog scale (VAS) | A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 5 cm horizontal line (between 0 and 5 points, 0 meaning 'no pain' and 5 meaning the worst) and this rating is then measured from the left edge (=Visual Analog Scale score). | postoperative 12th hour. | 
| visual analog scale (VAS) | A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 5 cm horizontal line (between 0 and 5 points, 0 meaning 'no pain' and 5 meaning the worst) and this rating is then measured from the left edge (=Visual Analog Scale score). | postoperative16th hour. | 
| visual analog scale (VAS) | A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 5 cm horizontal line (between 0 and 5 points, 0 meaning 'no pain' and 5 meaning the worst) and this rating is then measured from the left edge (=Visual Analog Scale score). | postoperative 24th hour. | 
| time to start oral intake | the time the patient start to consume orally after the operation | to be observed until the start of oral intake after the operation. it will be assessed up to 720 hours. | 
| mobilization time | the time the patient was start to walk after the operation | to be observed until the start of walking after the operation. it will be assessed up to 720 hours. | 
| urinary catheter withdrawal time | the time the urinary catheter was withdrawn after the operation | to be observed until the withdrawal of urinary catheter after the operation. it will be assessed up to 720 hours. | 
| hospitalization time | The time from the day the patient was hospitalized before the operation to the day of discharge after the operation. | from hospitalization for the operation to the day of discharge, it will be assessed up to 30 days. | 
| nasogastric withdrawal time | the time the nasogastric tube was withdrawn after the operation. | to be observed until the withdrawal of nasogastric tube after the operation. it will be assessed up to 720 hours. | 
| drain removal time | the time the abdominal drain was withdrawn after the operation. | to be observed until the withdrawal of abdominal drain after the operation. it will be assessed up to 720 hours. | 
| complications | all complications related with surgery or anesthesia | to be observed for 30 days postoperatively. | 
| blood pressure | patients' mean arterial pressure levels | preoperatively | 
| blood pressure | patients' mean arterial pressure levels | perioperatively. 30 minutes will be taken as the measurement period. | 
| FiCO2 | inspiratory carbondioxide level | preoperatively | 
| FiCO2 | inspiratory carbondioxide level | perioperatively. 30 minutes will be taken as the measurement period. | 
| sPO2 | oxygene saturation | preoperatively | 
| sPO2 | oxygene saturation | perioperatively. 30 minutes will be taken as the measurement period. |