Influence of high dose intraoperative remifentanil with or without amantadine on postoperative pain intensity and morphine consumption in major abdominal surgery patients

Phase 4

• Conditions: Postoperative pain intensity and morphine consumption after elective lower abdominal surergy

• Registration Number: DRKS00004626
• Lead Sponsor: Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin, Campus Charite Mitte und Virchow Klinikum, Charite - Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2007-04-30
• Study Start: 2013-04-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1) patients of at least 18 years; 2) American Society of Anaesthesiologists physical Status I – II; 3) open surgical procedures of the lower abdomen [(hemi-)colectomy, anterior rectum resection; abdominoperineal rectum resection; radical prostatectomy (RPX)] with an anticipated duration of anaesthesia of at least 90 minutes

Exclusion Criteria

(1) were operated by laparoscopy; (2) had to be transfused with = 2 units of packed red blood cells; (3) could not be extubated immediately after surgery; (4) had a chronic inflammatory disease, including inflammatory bowel disease; (5) had acute infection and/or SIRS/Sepsis; (6) had used opioids within 12 h before surgery4; (7) had a history of drug or alcohol abuse, psychiatric disorders or obesity (BMI > 30 kg/m2); (8) had contraindications to the self-administration of opioids (i.e., patients were unable to understand the patient-controlled intravenous analgesia [PCIA] device or had obstructive sleep apnea syndrome); (9) had contraindications to the use of amantadine (e.g., heart rhythm or conductance disturbance, renal insufficiency, epilepsy, delirium)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative pain intensity measured by numerical rating scale (NRS) in the 0./1./2./3./4./6. hour with PCIA

Secondary Outcome Measures

Name	Time	Method
Postoperative morphine consumption measured in milligramm in the 0./1./2./3./4./6. hour with PCIA