Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05334251
Enrollment
60
Registered
2022-04-19
Start date
2022-04-30
Completion date
2023-04-30
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, 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.

Interventions

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.

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
visual analog scale (VAS)postoperative 2nd 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).
time to start oral intaketo 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
mobilization timeto 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
urinary catheter withdrawal timeto 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 timefrom 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.
nasogastric withdrawal timeto 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.
drain removal timeto 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.
complicationsto be observed for 30 days postoperatively.all complications related with surgery or anesthesia
blood pressurepreoperativelypatients' mean arterial pressure levels
FiCO2preoperativelyinspiratory carbondioxide level
sPO2preoperativelyoxygene saturation

Contacts

Primary ContactAyça Tuba Dumanlı Özcan, MD
draycaozcan@gmail.com+905057154125

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026