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

• Conditions: Anesthesia; Colon Cancer
• Interventions: Other: combined spinal-epidural anesthesia

• Registration Number: NCT05334251
• Lead Sponsor: Ankara City Hospital Bilkent

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-19
• Status Verified: 2022-04
• Study Start: 2022-04
• Study First Submitted QC: 2022-04-12
• Last Update Submitted: 2022-04-12
• Study First Posted: 2022-04-19
• Last Update Posted: 2022-04-19
• Primary Completion: 2023-03
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
combined spinal-epidural anesthesia group	combined spinal-epidural anesthesia	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.

Primary Outcome Measures

Name	Time	Method
urinary catheter withdrawal time	to be observed until the withdrawal of urinary catheter after the operation. it will be assessed up to 720 hours.	the time the urinary catheter was withdrawn after the operation
hospitalization time	from hospitalization for the operation to the day of discharge, it will be assessed up to 30 days.	The time from the day the patient was hospitalized before the operation to the day of discharge after the operation.
sPO2	perioperatively. "30 minutes" will be taken as the measurement period.	oxygene saturation
visual analog scale (VAS)	postoperative 24th hour.	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).
drain removal time	to be observed until the withdrawal of abdominal drain after the operation. it will be assessed up to 720 hours.	the time the abdominal drain was withdrawn after the operation.
mobilization time	to be observed until the start of walking after the operation. it will be assessed up to 720 hours.	the time the patient was start to walk after the operation
blood pressure	perioperatively. "30 minutes" will be taken as the measurement period.	patients' mean arterial pressure levels
complications	to be observed for 30 days postoperatively.	all complications related with surgery or anesthesia
FiCO2	perioperatively. "30 minutes" will be taken as the measurement period.	inspiratory carbondioxide level
time to start oral intake	to be observed until the start of oral intake after the operation. it will be assessed up to 720 hours.	the time the patient start to consume orally after the operation
nasogastric withdrawal time	to be observed until the withdrawal of nasogastric tube after the operation. it will be assessed up to 720 hours.	the time the nasogastric tube was withdrawn after the operation.