Transdermal Fentanyl and Melatonin Patches for Postoperative Pain Relief

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Přihlášení Registrace

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PostaveníDokončeno

Sponzoři

Ain Shams University

KLINICKÉ HODNOCENÍ: NCT02726126

BioSeek: NCT02726126

Klíčová slova

Abstraktní

Seventy five patients, aged 18-50 years, ASA I and II undergoing elective single level lumber laminectomy under general anesthesia were included in this randomized controlled double-blind study. Patients were randomly divided into 3 groups 25 each, C group patients received transdermal placebo patch, TDF group (50μg/h) and TDM group (7 mg). Assessment of postoperative pain, sedation, hemodynamic variables such as HR and MAP, postoperative monitoring of arterial SpO2 and side effects (e.g. nausea, vomiting, pruritis, respiratory depression and hemodynamic instability) were done 30 minutes, 1, 2, 6 and 12 hours postoperatively. Postoperative Patient`s and Surgeons` satisfaction, Intraoperative bleeding and plasma cortisol (µg / dl) postoperatively were also assessed.

Termíny

Poslední ověření:	03/31/2016
První předloženo:	03/28/2016
Odhadovaná registrace vložena:	03/30/2016
První zveřejnění:	03/31/2016
Poslední aktualizace byla odeslána:	04/02/2016
Poslední aktualizace zveřejněna:	04/04/2016
Aktuální datum zahájení studie:	02/28/2013
Odhadované datum dokončení primární:	03/31/2015
Odhadované datum dokončení studie:	03/31/2015

Stav nebo nemoc

Postoperative Pain

Intervence / léčba

Drug: Comparative study between transdermal fentanyl and melatonin patches on postoperative pain relief after lumber laminectomy

Fáze

Skupiny zbraní

Paže	Intervence / léčba
C group, (n=25) C group, (n=25) each patient received transdermal placebo patch
TDF group, (n=25) TDF group, (n=25) each patient received transdermal therapeutic system-fentanyl 50μg/h
TDM group, (n=25) TDM group, (n=25) each patient received transdermal therapeutic system containing 7 mg of melatonin

Kritéria způsobilosti

Věky způsobilé ke studiu	18 Years Na 18 Years
Pohlaví způsobilá ke studiu	All
Metoda vzorkování	Probability Sample
Přijímá zdravé dobrovolníky	Ano
Kritéria	Inclusion Criteria: - 75 patients aged between 18 and 50 years old - Both sex of ASA physical status I and II - 70-90 kg body weight - Height 160-180 cm - Undergoing elective single level lumber laminectomy under general anesthesia. Exclusion Criteria: - Patients with impaired kidney or liver functions - History of cardiac or central nervous system disease - History of drug or alcohol abuse - History of chronic pain or daily intake of analgesics - Uncontrolled medical disease (diabetes mellitus and hypertension) - History of intake of non-steroidal anti-inflammatory drugs or opioids within 24 h before surgery or allergy to the used medications - Coagulation defect - Local infection at the site of application of transdermal patch - Patient refusal or duration of surgery more than 120 minutes were excluded from the study.

Výsledek

Primární výsledná opatření

1. A mean difference of total analgesic (pethidine) consumption. [The total pethidine requirements (mg) 12 hours postop]

Transdermal Fentanyl and Melatonin Patches for Postoperative Pain Relief

Klíčová slova

melatonin

nauzea

zvracení

krvácení

respirační selhání