We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Optimal Multimodal Analgesia in Laparoscopic Cholecystectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment Phase
Cholecystolithiasis Drug: Gabapentin Drug: S-ketamine Drug: Lidocaine Drug: Droperidol Phase 4

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : October 2005
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 1. postoperative abilities over time in PACU
  2. 2. discharge time from PACU according to fixed criteria
  3. 3. consumption of analgesics and antiemetics in the PACU

Secondary Outcome Measures :
  1. 1. Degree of nursing requirements in the PACU
  2. 2. General tolerability of the regimens

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00209885


Contacts
Layout table for location contacts
Contact: Kenneth Jensen, M.D. +45 36 32 62 90 kenneth.jensen@hh.hosp.dk

Locations
Layout table for location information
Denmark
Dept of Anaesthesia, Hvidovre Hospital
Copenhagen, Hvidovre, Denmark, 2650
Contact: Kenneth Jensen, M.D.    +45 36 32 62 90    kenneth.jensen@hh.hosp.dk   
Principal Investigator: Kenneth Jensen, M.D.         
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Layout table for investigator information
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
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00209885    
Other Study ID Numbers: OMA-LC01
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: September 21, 2005
Last Verified: September 2005
Additional relevant MeSH terms:
Layout table for MeSH terms
Cholecystolithiasis
Cholelithiasis
Gallstones
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical
Lidocaine
Droperidol
Ketamine
Gabapentin
Esketamine
Anesthetics, Local
Anesthetics
 Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents