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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparative study between transdermal fentanyl and melatonin patches on postoperative pain relief after lumber laminectomy | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| A mean difference of total analgesic (pethidine) consumption. | The total pethidine requirements (mg) 12 hours postop |
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Inclusion Criteria:
Exclusion Criteria:
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This study was designed to be a randomized, placebo-controlled, double-blind parallel study in which the patients, investigators, anesthesiologists and the surgeons were blinded to the given treatment. This study was conducted in Ain-Shams university hospitals, from March 2013 to April 2015 on 75 patients aged between 18 and 50 years old of both sex of ASA physical status I and II of 70-90 kg body weight and height 160-180 cm undergoing elective single level lumber laminectomy under general anesthesia. The study protocol was approved from the institutional ethical committee and written informed consent was obtained from all the patients.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |