Cholecystolithiasis
Conditions
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
Interventions
Sponsors
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. Degree of nursing requirements in the PACU | — |
| 2. General tolerability of the regimens | — |
Countries
Denmark
Contacts
Primary ContactKenneth Jensen, M.D.
Outcome results
None listed