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Optimal Multimodal Analgesia in Laparoscopic Cholecystectomy

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ClinicalTrials.gov Identifier: NCT00209885
Recruitment Status : Unknown
Verified September 2005 by Hvidovre University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : September 21, 2005
Last Update Posted : September 21, 2005
Sponsor:
Information provided by:
Hvidovre University Hospital

Tracking Information
First Submitted Date  ICMJE September 14, 2005
First Posted Date  ICMJE September 21, 2005
Last Update Posted Date September 21, 2005
Study Start Date  ICMJE October 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2005)
  • 1. Degree of nursing requirements in the PACU
  • 2. General tolerability of the regimens
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Optimal Multimodal Analgesia in Laparoscopic Cholecystectomy
Official Title  ICMJE Not Provided
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
Detailed Description

Aim of the study: to compare postoperative complaints (PONV, pain, etc) and PACU discharge time between two groups:

  • A: standard of care (SOC)receiving intraoperative dexamethasone, ondansetron, ketorolac, and general anaesthesia with propofol, remifentanil and cisatracurium
  • B: SOC + preoperative gabapentin, intraoperative lidocain infusion, s-ketamin and droperidol.

Primary endpoints:

  • postoperative abilities over time
  • discharge time from PACU according to fixed criteria
  • consumption of analgesics and antiemetics in the PACU

Secondary endpoints:

  • degree of nursing requirements at the PACU
  • General tolerability of the regimes
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Cholecystolithiasis
Intervention  ICMJE
  • Drug: Gabapentin
  • Drug: S-ketamine
  • Drug: Lidocaine
  • Drug: Droperidol
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: September 14, 2005)
60
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Planned abdominal cholecystectomy
  • Intraoperative conversion of laparoscopic to laparotomic cholecystectomy
  • Allergy to part of the treatment regimens
  • Previous reactions to opioids (nausea, cognition)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00209885
Other Study ID Numbers  ICMJE OMA-LC01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Hvidovre University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kenneth Jensen, M.D. Dept of Anaesthesia, Acute Pain Service, Hvidovre Hospital, Copenhagen, Denmark
Study Chair: Claus Lund, dr.med.sci Dept of Anaesthesia, Hvidovre Hospital, Copenhagen, Denmark
PRS Account Hvidovre University Hospital
Verification Date September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP