Reduced opioid consumption through continuous infusion of physostigmine in addition to postoperative patient-controlled analgesia for nephrectomy

Phase 1

• Conditions: Postoperative pain; MedDRA version: 14.1Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2012-000130-19-AT
• Lead Sponsor: Medizinische Universität Graz, Univ. Klinik für Anästhesiologie und Intensivmedizin, Abt. Anästhesie und Intensivmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-23
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

at least 18 years of age
at least 50 kg body weight
PCA competent
ASA1-3
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

Asthma, COLD, iritis, obstructive ileus, stenoses or spasms of the intestinal, bile, or urinary tract, closed head trauma, EF<30%, perioperative MI, stroke within the past 6 months
known allergy, overreaction to or contraindications for hydromorphone, physostigmine
a history of alcohol/drug abuse
participant in another interventional study
pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: significantly reduced opoid consumption through continuous infusion of physostigmine during the first 24 hours after surgery;Secondary Objective: reduced VAS scores, lower incidence of side effects, reduced area of mechanical hyperalgesia;Primary end point(s): opioid requirement;Timepoint(s) of evaluation of this end point: 24 and 48 hours postoperative

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): VAS scores, side effects, areas of hyperalgesia;Timepoint(s) of evaluation of this end point: first 4 hours: every hour<br>the next 8 hours: every second hour<br>then every 4 hour (total of 48 hours)