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	Intervention	Phase
Cholecystolithiasis	Drug: Gabapentin  Drug: S-ketamine  Drug: Lidocaine  Drug: Droperidol	Phase IV

Further Study Details: 

Primary Outcomes: 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: 1. Degree of nursing requirements in the PACU; 2. General tolerability of the regimens
Expected Total Enrollment:  60

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

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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)

Please refer to this study by ClinicalTrials.gov identifier  NCT00209885

Kenneth Jensen, M.D.      +45 36 32 62 90    kenneth.jensen@hh.hosp.dk

Denmark, Hvidovre
      Dept of Anaesthesia, Hvidovre Hospital, Copenhagen,  Hvidovre,  2650,  Denmark

Study chairs or principal investigators

Kenneth Jensen, M.D.,  Principal Investigator,  Dept of Anaesthesia, Acute Pain Service, Hvidovre Hospital, Copenhagen, Denmark   
Claus Lund, dr.med.sci,  Study Chair,  Dept of Anaesthesia, Hvidovre Hospital, Copenhagen, Denmark   

Study ID Numbers:  OMA-LC01
Last Updated:  September 20, 2005
Record first received:  September 14, 2005
ClinicalTrials.gov Identifier:  NCT00209885
Health Authority: Denmark: Danish Medicines Agency
ClinicalTrials.gov processed this record on 2005-09-27