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NCT00209885 Clinical Trial

Optimal Multimodal Analgesia in Laparoscopic Cholecystectomy

Cholecystolithiasis Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00209885
Other study ID # OMA-LC01
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received September 14, 2005
Last updated September 14, 2005
Start date October 2005

Study information
Verified date September 2005
Source Hvidovre University Hospital
Contact Kenneth Jensen, M.D.
Phone +45 36 32 62 90
Email kenneth.jensen@hh.hosp.dk
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

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

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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)

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Gabapentin

• S-ketamine

• Lidocaine

• Droperidol

Locations
Country Name City State
Denmark Dept of Anaesthesia, Hvidovre Hospital Copenhagen Hvidovre

Sponsors (1)
Lead Sponsor Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary 1. postoperative abilities over time in PACU
Primary 2. discharge time from PACU according to fixed criteria
Primary 3. consumption of analgesics and antiemetics in the PACU
Secondary 1. Degree of nursing requirements in the PACU
Secondary 2. General tolerability of the regimens
See also
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Recruiting NCT02114437 - Closed-Loop Target Controlled Infusion in Laparoscopic Cholecystectomy Phase 4
Completed NCT01553331 - Day Case Laparoscopic Cholecystectomy: Fundus First With Ultrasonic Dissection or Conventional Diathermy Hook N/A
Recruiting NCT03909360 - Drainage or Not for Laparoscopic Cholecystetomy N/A
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