Colon CancerNCT05334251
General Anesthesia or Combined Spinal-epidural Anesthesia With Ketofol Sedation in Colon Cancer Surgery?
An observational study of Colon Cancer and Anesthesia, run by Ankara City Hospital Bilkent.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Colon Cancer, Anesthesia
- What is being tested?
- combined spinal-epidural anesthesia
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Apr 2022to Apr 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 40 years of age who are scheduled for open surgery with a diagnosis of colon cancer.
Who may be able to join
- Patients over 40 years of age who are scheduled for open surgery with a diagnosis of colon cancer
Who cannot join
- Local anesthetic allergy
- Patients scheduled for laparoscopic surgery
Trial locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- combined spinal-epidural anesthesia
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined spinal-epidural anesthesiaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: combined spinal-epidural anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: postoperative 24th hour.
time to start oral intake
the time the patient start to consume orally after the operation
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: to be observed for 30 days postoperatively.
blood pressure
patients' mean arterial pressure levels
Measured: preoperatively
blood pressure
patients' mean arterial pressure levels
Measured: perioperatively. "30 minutes" will be taken as the measurement period.
FiCO2
inspiratory carbondioxide level
Measured: preoperatively
FiCO2
inspiratory carbondioxide level
Measured: perioperatively. "30 minutes" will be taken as the measurement period.
sPO2
oxygene saturation
Measured: preoperatively
sPO2
oxygene saturation
Measured: perioperatively. "30 minutes" will be taken as the measurement period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study startApr 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayça Özcan, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334251
- Sponsor's protocol ID
- E2-21-1021
- Status last verified
- Apr 2022
- First submitted
- 19 Nov 2021
- Last updated
- 19 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33093029Cummings 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.
PubMed 29544203Ljungqvist 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.
PubMed 29453605Gustafsson 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.
PubMed 30426190
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Anesthesia or Combined Spinal-epidural Anesthesia With Ketofol Sedation in Colon Cancer Surgery?
- ClinicalTrials.gov ID
- NCT05334251
- Acronym / sponsor ID
- E2-21-1021
- Conditions
- Colon Cancer, Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: combined spinal-epidural anesthesiaPatients 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 40 years of age who are scheduled for open surgery with a diagnosis of colon cancer.
Key inclusion criteria (1 listed)
- Patients over 40 years of age who are scheduled for open surgery with a diagnosis of colon cancer
Key exclusion criteria (2 listed)
- Local anesthetic allergy
- Patients scheduled for laparoscopic surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| combined spinal-epidural anesthesiaCombined 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. | Other | combined spinal-epidural anesthesia group |
Primary outcome
visual analog scale (VAS)
Time frame: 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).
visual analog scale (VAS)
Time frame: postoperative 4th 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).
visual analog scale (VAS)
Time frame: postoperative 8th 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).
visual analog scale (VAS)
Time frame: postoperative 12th 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).
visual analog scale (VAS)
Time frame: postoperative16th 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).
visual analog scale (VAS)
Time frame: 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).
time to start oral intake
Time frame: 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
mobilization time
Time frame: 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
urinary catheter withdrawal time
Time frame: 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
Time frame: 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.
nasogastric withdrawal time
Time frame: 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.
drain removal time
Time frame: 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.
complications
Time frame: to be observed for 30 days postoperatively.
all complications related with surgery or anesthesia
blood pressure
Time frame: preoperatively
patients' mean arterial pressure levels
blood pressure
Time frame: perioperatively. "30 minutes" will be taken as the measurement period.
patients' mean arterial pressure levels
FiCO2
Time frame: preoperatively
inspiratory carbondioxide level
FiCO2
Time frame: perioperatively. "30 minutes" will be taken as the measurement period.
inspiratory carbondioxide level
sPO2
Time frame: preoperatively
oxygene saturation
sPO2
Time frame: perioperatively. "30 minutes" will be taken as the measurement period.
oxygene saturation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Background: PubMed 33093029Wu 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.
- Background: PubMed 29544203Cummings 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.
- Background: PubMed 29453605Ljungqvist 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.
- Background: PubMed 30426190Gustafsson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer and Anesthesia, run by Ankara City Hospital Bilkent.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayça Tuba Dumanlı Özcan, MD (+905057154125, draycaozcan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analog scale (VAS) (time frame: postoperative 2nd hour.). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05334251, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022.