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Clinical Trials/NCT01394445
NCT01394445CompletedPhase 3

Influence of Physostigmine on Patient-Controlled Analgesia

Medical University of Graz1 site in 1 country20 target enrollmentStarted: June 2011Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Enrollment
20
Locations
1
Primary Endpoint
opioid consumption

Study Overview

Brief Summary

The investigators hypothesize that the administration of physostigmine in the postoperative period after nephrectomy reduces opioid consumption.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • At least 18 years old
  • At least 50 kg
  • Suitable for PCA

Exclusion Criteria

  • Bronchial asthma/severe or exacerbated COPD
  • Stenoses/spasms of intestine, urinary tract, biliary tract
  • Closed traumatic brain injury
  • Severely reduced left ventricular function (EF<30%)
  • Recent myocardial infarction
  • Recent stroke
  • Known allergy or hypersensitivity or contraindications against hydromorphone, physostigmine
  • History of alcohol or drug abuse
  • Patients enrolled in another study
  • Women of childbearing age without a negative pregnancy test

Arms & Interventions

Physostigmine

Active Comparator

Intervention: Physostigmine (Drug)

Placebo

Placebo Comparator

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

opioid consumption

Time Frame: 24 hours

Secondary Outcomes

  • pain scores(24 hours)

Investigators

Sponsor
Medical University of Graz
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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