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Clinical Trial 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


Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00209885
Study type Interventional
Source Hvidovre University Hospital
Contact Kenneth Jensen, M.D.
Phone +45 36 32 62 90
Email kenneth.jensen@hh.hosp.dk
Status Not yet recruiting
Phase Phase 4
Start date October 2005

See also
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