NCT00209885

Brief Summary

To test the current standard of care (SOC) treatment for laparoscopic cholecystectomy with a group receiving SOC + additional perioperative analgesics in terms of postoperative abilities, PONV, pain and discharge time from the PACU

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
Last Updated

September 21, 2005

Status Verified

September 1, 2005

First QC Date

September 14, 2005

Last Update Submit

September 14, 2005

Conditions

Cholecystolithiasis

Outcome Measures

Primary Outcomes (3)

  • 1. postoperative abilities over time in PACU

  • 2. discharge time from PACU according to fixed criteria

  • 3. consumption of analgesics and antiemetics in the PACU

Secondary Outcomes (2)

  • 1. Degree of nursing requirements in the PACU

  • 2. General tolerability of the regimens

Interventions

GabapentinDRUG
S-ketamineDRUG
LidocaineDRUG
DroperidolDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective laparoscopic cholecystectomy
  • Age above 18 years
  • Written informed consent
  • ASA class I-III

You may not qualify if:

  • Planned abdominal cholecystectomy
  • Intraoperative conversion of laparoscopic to laparotomic cholecystectomy
  • Allergy to part of the treatment regimens
  • Previous reactions to opioids (nausea, cognition)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Anaesthesia, Hvidovre Hospital

Copenhagen, Hvidovre, 2650, Denmark

Location

Related Links

MeSH Terms

Conditions

Cholecystolithiasis

Interventions

GabapentinEsketamineLidocaineDroperidol

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesGallbladder Diseases

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and ProteinsAcetanilidesAnilidesAmidesAniline CompoundsButyrophenonesKetonesBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Kenneth Jensen, M.D.

    Dept of Anaesthesia, Acute Pain Service, Hvidovre Hospital, Copenhagen, Denmark

    PRINCIPAL INVESTIGATOR

  • Claus Lund, dr.med.sci

    Dept of Anaesthesia, Hvidovre Hospital, Copenhagen, Denmark

    STUDY CHAIR

Central Study Contacts

Kenneth Jensen, M.D.

CONTACT

+45 36 32 62 90kenneth.jensen@hh.hosp.dk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 21, 2005

Study Start

October 1, 2005

Last Updated

September 21, 2005

Record last verified: 2005-09

Locations

DK(1)