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Optimal Multimodal Analgesia in Laparoscopic Cholecystectomy
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by Hvidovre University Hospital.
Recruitment status was: Not yet recruiting
Recruitment status was: Not yet recruiting
Sponsor:
Hvidovre University Hospital
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00209885
First received: September 14, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
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Purpose
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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
Further study details as provided by Hvidovre University Hospital:
Primary Outcome Measures:
- 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 Outcome Measures:
- 1. Degree of nursing requirements in the PACU
- 2. General tolerability of the regimens
| Estimated Enrollment: | 60 |
| Study Start Date: | October 2005 |
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
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00209885
Please refer to this study by its ClinicalTrials.gov identifier: NCT00209885
Contacts
| Contact: Kenneth Jensen, M.D. | +45 36 32 62 90 | kenneth.jensen@hh.hosp.dk |
Locations
| Denmark | |
| Dept of Anaesthesia, Hvidovre Hospital | Not yet recruiting |
| 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
| 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
Additional Information:
| ClinicalTrials.gov Identifier: | NCT00209885 History of Changes |
| Other Study ID Numbers: |
OMA-LC01 |
| Study First Received: | September 14, 2005 |
| Last Updated: | September 14, 2005 |
Additional relevant MeSH terms:
|
Cholecystolithiasis Cholelithiasis Gallstones Biliary Tract Diseases Digestive System Diseases Gallbladder Diseases Calculi Pathological Conditions, Anatomical Lidocaine Ketamine Gabapentin Droperidol 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 Neurotransmitter Agents |
ClinicalTrials.gov processed this record on June 26, 2017