CLONIDINE HYDROCHLORIDE for Colorectal cancer|Postoperative acute pain

Inclusion criteria

• {"criterion_text":"- Planned colectomy due to cancer.\n- Age over 18 years.\n- Able to read and understand Danish.\n- Willingness and able to comply with scheduled visit, treatment plan, laboratory tests and other trial procedures."}

Exclusion criteria

• {"criterion_text":"- Sick sinus syndrome.\n- Second- or third-degree atrioventricular block.\n- Known hypersensitivity, intolerance or allergy towards clonidine or morphine.\n- Clinically relevant side effects or symptoms of allergy, judged by the investigator.\n- Pregnancy (positive urine HCG)/ lactating.\n- Participants with any clinical abnormalities that, in the opinion of the investigator, may increase the risk associated with trial participation or may interfere with the interpretation of the trial results\n- Participation in other clinical studies less than six month prior to inclusion.\n- Hypotension (persistent systolic blood pressure below 100 mmHg).\n- Bradycardia (< 50 beats/minute).\n- Known significant decreased kidney function, or an eGFR below 30 ml/min.\n- Use of a α-agonist drug. (Clonidine, Dexmedetomidine, Tizanidine).\n- Use of a α-adrenoceptor blocking drug. (Phentolamine, Tolazoline, Phenoxybenzamine, Prazosin, Terazosin, Doxazosin, Alfuzosin, Bunazosin, Tamsulosin, Silodosin, Yohimbine, Idazoxan, Ergot alkaloids)."}

Primary endpoints

• {"endpoint_text":"- Use of morphine 24 hours post-operatively","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- VAS/NRS (pain scores), Qestionnaires, QST (Quantitative Sensory Testing), ANS (BP, ECG, HR, Sat, Tp, Pupil reaction), Certain genetic profile (CYP2D6, OPRM and COMT sequenced. SNPs of ABCB1 and rs2952768/CREB1 and ncRNA), Blood samples (concentrations of clonidine, morphine, morphine-3-glucoronide, morphine-6-glucoronide), Demographics, physical, medical, laboratory data, Physical examination.","definition_or_measurement_approach":""}

Denmark

Earliest CTIS Part Ii Submission Date

24-09-2024

Latest Decision Or Authorization Date

17-12-2024

Processing Time Days

84

Number Of Sites

1

Number Of Participants

182

Primary sponsor

Full Name

Esbjerg Og Grindsted Sygehus

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Odense University Hospital","duties_or_roles":"code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}