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

Immune protective anesthesia during endoscopic colon surgery to improve long-term survival - Immune protective strategy for oncological endoscopic colon surgery (IPSEC)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46294

Enrollment

366

Registered

2017-04-10

Start date

2017-06-01

Completion date

Unknown

Last updated

2025-03-24

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

Conditions

immune system narcosis

Interventions

Patients will be randomized in two groups: 1. Conventional anesthesia: - Preopartive Paracetamol - Intravenous analgesia with opioids and postoperative pain management with Dipidolor or morphine acc

dosage according to the bispectral index scale (BIS) with target values between 40 and 60. - Ketamine, Clonidine and Dexamethason according to the judgment of the anesthesiologist. - No Dexmedetom

dosage according to the bispectral index scale (BIS) with target values between 40 and 60. - Without peri- or postoperative use of opiates, Ketamine, Clonidine or Dexamethason - Hypotension should

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - All patients approved by the anesthesiologist for elective endoscopic colon surgery for cancer. - > 18 year with written informed consent

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 a any of the listed medications 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 use

Design outcomes

Primary

Measure	Time frame
Primary study parameters: immunological response 24hr-postoperative	—

Secondary

Measure	Time frame
Secundary study parameters: 1. Is there a 48hr-postoperative difference in immunological response between conventional and immune protective anesthesia? 2. Postoperative complications according to the Clavien Dindo classification 3. Postoperative VAS (Visual Analogue Scale) score 4. Hospital stay 5. Anesthetic variables Exploratory endpoint: 1. Cancer free survival of colon surgery (follow up to 5 years postoperative) During anesthesia: 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. Patient*s characteristics: age, BMI, smoking habits, medical history, ASA classification, tumor characteristics (histology, stage, TNM classification, localization).	—

Measure

Time frame

Secundary study parameters: 1. Is there a 48hr-postoperative difference in immunological response between conventional and immune protective anesthesia? 2. Postoperative complications according to the Clavien Dindo classification 3. Postoperative VAS (Visual Analogue Scale) score 4. Hospital stay 5. Anesthetic variables Exploratory endpoint: 1. Cancer free survival of colon surgery (follow up to 5 years postoperative) During anesthesia: 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. Patient*s characteristics: age, BMI, smoking habits, medical history, ASA classification, tumor characteristics (histology, stage, TNM classification, localization).

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)