‘Immune protective anesthesia during endoscopic colon surgery to improve long-term survival’

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000867-34-NL

Enrollment

300

Registered

2017-04-10

Start date

2017-10-03

Completion date

Unknown

Last updated

2017-11-06

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

Conditions

We will include patients with colon cancer receiving endoscopic resection of tumor

Interventions

Trade Name: dexdor Pharmaceutical Form: Solution for infusion INN or Proposed INN: DEXMEDETOMIDINE CAS Number: 113775-47-6 Concentration unit: µg/kg microgram(s)/kilogram Concentration type: range Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - All patients approved by the anesthesiologist for elective endoscopic colon surgery for cancer. - > 18 year with written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200

Exclusion criteria

Exclusion criteria: - neoadjuvant chemo and/or radiotherapy - Perioperatieve conversion to an open surgical approach - Insufficient pain relief in the intervention group (Visual Analogue Scale (VAS) = 4) - Absolute contra-indications for the use of any of the listed medications or procedures (epidural) in the intervention group - Synchronous metastasis (stage IV/ M1 patients) - Patients who are mentally disabled or incapable to give informed consent - Patients on chronic opioid therapy

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the immunological response between two different anesthesia strategies ;Secondary Objective: 1. Cancer free survival (follow up to 5 years postoperative) 2. Minor and major postoperative complications 3. Postoperative VAS (Visual Analogue Scale) score 4. Hospital stay 5. Anesthetic variables ;Primary end point(s): Immunological markers;Timepoint(s) of evaluation of this end point: After inclusion of last patient	—

Measure

Time frame

Main Objective: To compare the immunological response between two different anesthesia strategies ;Secondary Objective: 1. Cancer free survival (follow up to 5 years postoperative) 2. Minor and major postoperative complications 3. Postoperative VAS (Visual Analogue Scale) score 4. Hospital stay 5. Anesthetic variables ;Primary end point(s): Immunological markers;Timepoint(s) of evaluation of this end point: After inclusion of last patient

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Secondary

Measure	Time frame
Secondary end point(s): 1. Cancer free survival (follow up to 5 years postoperative) 2. Minor and major postoperative complications 3. Postoperative VAS (Visual Analogue Scale) score 4. Hospital stay 5. Anesthetic variables such as:blood pressure, heart rate, respiratory rate, carbon dioxide concentration, saturation, and BIS values will be documented prior before anesthesia and every 10 minutes thereafter. Data will be collected prospectively ;Timepoint(s) of evaluation of this end point: secondary endpoint 1 , 5 years after inclusion of last patient. Other secondary markers after inclusion of last patient.	—

Measure

Time frame

Secondary end point(s): 1. Cancer free survival (follow up to 5 years postoperative) 2. Minor and major postoperative complications 3. Postoperative VAS (Visual Analogue Scale) score 4. Hospital stay 5. Anesthetic variables such as:blood pressure, heart rate, respiratory rate, carbon dioxide concentration, saturation, and BIS values will be documented prior before anesthesia and every 10 minutes thereafter. Data will be collected prospectively ;Timepoint(s) of evaluation of this end point: secondary endpoint 1 , 5 years after inclusion of last patient. Other secondary markers after inclusion of last patient.

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Countries

Netherlands

Contacts

Public Contactcoordinator

UMCG

r.spanjersberg@umcg.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026