Placebo-controlled double-blind trial of the analgesic effect and safety of clonidine in patients after major abdominal surgery

Phase 4

Not yet recruiting

Conditions: Trial participants are having colectomy due to cancer

Interventions: Drug: -

Registration Number: 2024-516325-31-01

Lead Sponsor: Esbjerg Og Grindsted Sygehus

Brief Summary: The relationship between a single iv. bolus dose of clonidine administered postoperatively to patients undergoing colectomy and postoperative acute pain.

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised, recruitment pending

Sex: Not specified

Target Recruitment: 182

Inclusion Criteria

• Planned colectomy due to cancer. • Age over 18 years. • Able to read and understand Danish. • Willingness and able to comply with scheduled visit, treatment plan, laboratory tests and other trial procedures.

Exclusion Criteria

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

Study & Design

Study Type: Not specified

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
-	-	Participants receiving -

Primary Outcome Measures

Name	Time	Method
Use of morphine 24 hours post-operatively		Use of morphine 24 hours post-operatively

Secondary Outcome Measures

Name	Time	Method
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.		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.

Trial Locations

Locations (1): Esbjerg Og Grindsted Sygehus
🇩🇰
Esbjerg, Denmark
Esbjerg Og Grindsted Sygehus
🇩🇰Esbjerg, Denmark
Rasmus Petersen
Site contact
+4561775220
rasmus.hjelmar.petersen@rsyd.dk