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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05334251
• Other study ID #: E2-21-1021
• Status: Not yet recruiting
• Start date: April 2022
• Est. completion date: April 2023

Study information

• Verified date: April 2022
• Source: Ankara City Hospital Bilkent
• Contact: Ayça Tuba Dumanli Özcan, MD
• Phone: +905057154125
• Email: draycaozcan[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Colon Cancer
• Colonic Neoplasms

Intervention

Other:
• combined spinal-epidural anesthesia
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

References & Publications (4)

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. — View Citation

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(®)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	complications	all complications related with surgery or anesthesia	to be observed for 30 days postoperatively.
Primary	blood pressure	patients' mean arterial pressure levels	preoperatively
Primary	blood pressure	patients' mean arterial pressure levels	perioperatively. "30 minutes" will be taken as the measurement period.
Primary	FiCO2	inspiratory carbondioxide level	preoperatively
Primary	FiCO2	inspiratory carbondioxide level	perioperatively. "30 minutes" will be taken as the measurement period.
Primary	sPO2	oxygene saturation	preoperatively
Primary	sPO2	oxygene saturation	perioperatively. "30 minutes" will be taken as the measurement period.