Skip to content

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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
DRKS
Registry ID
DRKS00004626
Enrollment
60
Registered
2013-04-30
Start date
2003-10-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Postoperative pain intensity and morphine consumption after elective lower abdominal surergy

Interventions

Group 1: “low dose remifentanil plus preoperative saline” (RL): a remifentanil infusion was maintained at a rate of 0,1 µg kg-1 min-1 throughout anaesthesia, whereas the endtidal Vol.-% of sevoflurane
preoperatively 500ml NaCl 0,9% were infused as study solution Group 2: “high dose remifentanil plus preoperative saline” (RH): the endtidal Vol.-% of sevoflurane was maintained at 0,5 MAC throughout a
a remifentanil infusion was started at a rate of 0,2 µg kg-1 min-1 and subsequently increased by 0,05 µg kg-1 min-1 increments to clinical demand
preoperatively these patients also received an infusion of 500ml NaCl 0,9% as study solution Group 3: “high dose remifentanil plus preoperative amantadine” (RHA): the same anaesthetic protocol as grou

Sponsors

Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin, Campus Charite Mitte und Virchow Klinikum, Charite - Universitätsmedizin Berlin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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)

Design outcomes

Primary

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

Secondary

MeasureTime frame
Postoperative morphine consumption measured in milligramm in the 0./1./2./3./4./6. hour with PCIA

Countries

Germany

Contacts

Public ContactSascha Treskatsch

Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin, Campus Charite Mitte und Virchow Klinikum, Charite - Universitätsmedizin Berlin

sascha.treskatsch@charite.de030450531052

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 10, 2026