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

PHANOS (PHysostigmine-enHAnced Opioid analgeSia) study - PHANOS2012

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000130-19-AT

Enrollment

110

Registered

2012-07-23

Start date

2012-08-30

Completion date

Unknown

Last updated

2024-03-12

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

Conditions

Postoperative pain MedDRA version: 14.1 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: ANTICHOLIUM – AMPULLEN Pharmaceutical Form: Solution for infusion CAS Number: 57-64-7 Other descriptive name: PHYSOSTIGMINE SALICYLATE Concentration unit: mg milligram(s) Concentration typ

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Austria

Contacts

Public ContactInformation Klinische Studien

Medizinische Universität Graz, Univ. Klinik für Anästhesiologie und Intensivmedizin, Abt. Anästhesie und Intensivmedizin

anaesthesie@medunigraz.at43316385 14909

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026