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The aim of the current study is to compare the analgesic effects of both drugs in patients with obesity undergoing bariatric surgery.
Upon arrival to the operating room, routine monitors (electrocardiogram, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and prophylactic antiemetic will be provided in the form of slow intravenous injection of 5 mg dexamethasone drugs.
Anesthesia Anesthesia will be induced with 2 mg/kg propofol, 2 mcg/kg fentanyl (lean body weight), and tracheal intubation will be facilitated by 0.6 mg/kg ideal body weight rocuronium after loss of consciousness. Anesthesia will be maintained with isoflurane 1-1.2% in oxygen and 0.1 mg/kg rocuronium every 30 minutes. Fentanyl boluses of 1 mcg/kg will be given if heart rate or/and systolic blood pressure >120% of baseline.
Postoperatively, pain assessments using the visual analogue scale (VAS) will be performed at rest and during movement (knee flexion) at 0.5, 4, 10, 18, and 24 h after leaving the operating room. If the VAS score is > 3 intravenous nalbuphine 0.1-0.2 mg/kg (lean body weight) titrated to response with maximum single dose of 20 mg and maximum daily dose of 160 mg.
Intravenous ondansetron 4 mg will be given to treat postoperative nausea or vomiting
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketorolac group | Active Comparator | ketorolac 30 mg (diluted in 200 mL normal saline) intravenously over 5 minutes |
|
| Ibuprofen group | Active Comparator | ibuprofen 800 mg intravenously (Diluted in 200 mL of normal saline) over 5 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac group | Drug | 30 min preoperatively then every 8 hours postoperatively |
| |
| Measure | Description | Time Frame |
|---|---|---|
| VAS | Visual analogue scale | 30 minutes after extubation |
| Measure | Description | Time Frame |
|---|---|---|
| total intraoperative fentanyl | mcg | 30 seconds after skin incision until 1 min after skin closure |
| post operative nalbuphine | mg | 30 minutes after extubation until 24 hours postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maha Mostafa | Contact | 01000365115 | maha.mostafa@cu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Cairo | Egypt |
data from this study are available from the PI upon resealable request
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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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| Ibuprofen group |
| Drug |
30 min preoperatively then every 8 hours postoperatively |
|
| VAS | Visual analogue scale | at 0.5, 4, 10, 18, and 24 hours after extubation |
| time to independent movement | defined as time from extubation to be able independently mobile e.g. using the bathroom | 30 minutes after extubation until 24 hours postoperatively |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |