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

A

Ankara City Hospital

Status

Unknown

Conditions

Colon Cancer
Anesthesia

Treatments

Other: combined spinal-epidural anesthesia

Study type

Observational

Funder types

Other

Identifiers

NCT05334251
E2-21-1021

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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

Trial design

60 participants in 2 patient groups

general anesthesia group
Description:
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
Description:
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.
Treatment:
Other: combined spinal-epidural anesthesia

Trial documents
1

Trial contacts and locations

0

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Central trial contact

Ayça Tuba Dumanlı Özcan, MD

Data sourced from clinicaltrials.gov

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