Intravenous Lidocaine in Bariatric Surgery.
Ключові слова
Анотація
Опис
This is a prospective, double-blind, placebo-controlled, monocentric study. We plan to recruit 180 obese adult patients scheduled for bariatric surgery in a the french university hospital of Caen.
Exclusion: contra-indications for any aminoamide local anesthetic (allergy, severe hepatic disease) and for intravenous lidocaine (porphyria, atrioventricular conduction disturbances, uncontrolled seizure disease), long term opioid consumption, need for a post-operative follow-up in an intensive care unit, combined surgical procedure excepting cholecystectomy, pregnancy.
Patients will be randomly allocated to receive either a saline placebo or lidocaine continuous infusions during surgery. Morphinic consumption will be assessed from the end of the procedure until the third day after surgery. Secondary criteria will concern post-operative recovery, pain and postoperative nausea and vomiting, other medical and surgical complications, and toxicity. Plasma lidocaine concentrations will be measured in patients who had received lidocaine in order to determine the safety and efficiency of our infusion protocol.
Our analysis will be a superiority one, alpha risk is 5% and beta risk is 20%, in intention to treat, with no intermediate analysis.
Дати
| Востаннє перевірено: | 04/30/2017 |
| Перший поданий: | 05/30/2017 |
| Орієнтовна реєстрація подана: | 07/05/2017 |
| Опубліковано вперше: | 07/06/2017 |
| Останнє оновлення надіслано: | 07/11/2017 |
| Останнє оновлення опубліковано: | 07/13/2017 |
| Фактична дата початку навчання: | 07/31/2017 |
| Розрахункова дата первинного завершення: | 01/31/2019 |
| Розрахункова дата завершення дослідження: | 04/30/2019 |
Стан або захворювання
Втручання / лікування
Drug: Lidocaine
Drug: Control
Фаза
Групи рук
| Рука | Втручання / лікування |
|---|---|
| Placebo Comparator: Control intravenous isotonic saline administration : bolus of 0.075 ml/kg (adjusted body weight) at induction of anesthesia followed by a continuous infusion (0.1 ml/kg/h, adjusted body weight) until the end of surgery decrease to 0.05 ml/kg (adjusted body weight) during 60 min in post anesthesia care unit.
Speed of infusion were calculated to be equivalent to that of lidocaine speed of injection. | Drug: Control intravenous isotonic saline |
| Experimental: Lidocaine Intravenous Lidocaine (20mg/ml) : bolus of 1.5 mg/kg (adjusted body weight) at induction of anesthesia followed by a continuous infusion (2.0 mg/kg/h, adjusted body weight) until the end of surgery decrease to 1.0 mg/kg (adjusted body weight) during 60 min in post anesthesia care unit. | Drug: Lidocaine intravenous lidocaine versus placebo |
Критерії прийнятності
| Вік, придатний для навчання | 18 Years До 18 Years |
| Стать, яка підходить для вивчення | All |
| Приймає здорових добровольців | Так |
| Критерії | Inclusion Criteria: - scheduled bariatric surgery Exclusion Criteria: - any contra-indication for lidocaine administration - pregnancy - ASA class 4 - psychiatric disorder - chronic opioid consumption |
Результат
Заходи первинного результату
1. oxycodone consumption [three days following surgery]
Заходи вторинного результату
1. lidocaine plasma concentration [during post anesthesia care unit stay (1 day)]
2. hospital discharge check list [three days following surgery]
3. postoperative pain [three days following surgery]
4. nausea and vomiting [three days following surgery]
5. intestinal transit recovery [three days following surgery]
6. hospital length of stay [through hospital discharge (an average of 1 week)]
