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

NCT05334251 | Unknown

• 1 other identifier: E2-21-1021
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colon Cancer; Anesthesia

Outcome Measures

Primary Outcomes (19)

• 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.

Study Arms (2)

general anesthesia group

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

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

Interventions

combined spinal-epidural anesthesia OTHER

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.

combined spinal-epidural anesthesia group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Local anesthetic allergy
• Patients scheduled for laparoscopic surgery

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Related Publications (4)

• 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.

  PMID: 33093029 BACKGROUND

• 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.

  PMID: 29544203 BACKGROUND

• 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.

  PMID: 29453605 BACKGROUND

• 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.

  PMID: 30426190 BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Central Study Contacts

Ayça Tuba Dumanlı Özcan, MD

CONTACT

+905057154125; draycaozcan@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: April 19, 2022
• Study Start: April 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: April 1, 2023
• Last Updated: April 19, 2022

Record last verified: 2022-04