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Assessment of the clinical efficacy and adverse effects of multimodal analgesic regimen consisting of nalbuphine combined with ketorolac using IV continuous infusion silicon device (Accufuser) for postoperative analgesia following multilevel OSA surgeries
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OSA patients after multilevel surgery | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nalbuphine, ketorolac, accufuser | Combination Product | multimodal analgesic regimen consisting of nalbuphine combined with ketorolac using IV continuous infusion silicon device (Accufuser) |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | visual analog pain score | Assessment will be carried out at zero time (time to shift to PACU) . |
| Postoperative pain | Visual analog pain score | Assessment will be carried out 6 hours postoperatively |
| Postoperative pain | Visual analog pain score | Assessment will be carried out 12 hours postoperatively |
| Postoperative pain | Visual analog pain score | Assessment will be carried out 18 hours postoperatively |
| Postoperative pain | Visual analog pain score | Assessment will be carried out 24 hours postoperatively |
| Postoperative pain | Visual analog pain score | Assessment will be carried out 30 hours postoperatively |
| Postoperative pain | Visual analog pain score | Assessment will be carried out 36 hours postoperatively |
| Postoperative pain | Visual analog pain score | Assessment will be carried out 42 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Sedation level | Ramsey sedation scale | Zero time ( time to shift to PACU) |
| Sedation level | Ramsey sedation scale | 6 hours postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bahaa M Refaie, MD | Contact | 0201026887257 | bahaarefaay@med.sohag.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Bahaa M Refaie, MD | Lecturer of anesthesia and ICU sohag university | Principal Investigator |
| Mohammed E Ahmed, MD | Lecturer of ENT sohag university | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sohag faculty of medicine | Recruiting | Sohag | 82524 | Egypt |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D009266 | Nalbuphine |
| D020910 | Ketorolac |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Postoperative pain | Visual analog pain score | Assessment will be carried out 48 hours postoperatively |
| Sedation level | Ramsey Sedation Scale | 12 hours postoperatively |
| Sedation level | Ramsey Sedation Scale | 18 hours postoperatively |
| Sedation level | Ramsey Sedation Scale | 24 hours postoperatively |
| Sedation level | Ramsey Sedation scale | 30 hours postoperatively |
| Sedation level | Ramsey Sedation Scale | 36 hours postoperatively |
| Sedation level | Ramsey Sedation Scale | 42 hours postoperatively |
| Sedation level | Ramsey Sedation Ramsey Sedation Scale | 48 hours postoperatively |
| incidence of adverse effects | hypoxia, nausea, vomiting, itching | Zero time ( time to shift to PACU) |
| incidence of adverse effects | hypoxia, nausea, vomiting, itching | 6 hours postoperatively |
| incidence of adverse effects | hypoxia, nausea, vomiting, itching | 12 hours postoperatively |
| incidence of adverse effects | hypoxia, nausea, vomiting, itching | 18 hours postoperatively |
| incidence of adverse effects | hypoxia, nausea, vomiting, itching | 24 hours postoperatively |
| incidence of adverse effects | hypoxia, nausea, vomiting, itching | 30 hours postoperatively |
| incidence of adverse effects | hypoxia, nausea, vomiting, itching | 36 hours postoperatively |
| incidence of adverse effects | hypoxia, nausea, vomiting, itching | 42 hours postoperatively |
| incidence of adverse effects | hypoxia, nausea, vomiting, itching | 48 hours postoperatively |
| A M Elhalwagy, MD |
| Consultant of pain medicine |
| Study Chair |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |