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Implementation of enhanced recovery in day case surgeries using either preemptive intravenous paracetamol plus tramadol or preemptive intravenous fentanyl.
after being informed about the study and potential risks. All patients giving written consent will be randomized by double blind manner into two equal groups (T group and F group). Using computer generated randomization table; each group consists of 51 patients:Group (T) (n=51): Patients will receive preemptive intravenous infusion of tramadol plus paracetamol .
Group (F) (n=51): Patients will receive preemptive intravenous fentanyl.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tramadol plus paracetamol (T) | Experimental |
| |
| fentanyl(F) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tramadol plus paracetamol | Drug | Intravenous infusion of 15mg/kg paracetamol together with 1mg/kg tramadol will be started and to be finished before starting of induction of anesthesia (induction agent will be propofol 2mg/kg and muscle relaxant (cisatracurium) 0.15 mg/kg) |
| Measure | Description | Time Frame |
|---|---|---|
| Enhanced recovery score | A 40-item questionnaire that provides a score (QoR-40) that measure quality of recovery after surgery and anesthesia (enhanced recovery) according to five aspects will be recorded at the end of 24 hours after surgery: Emotional state(n=9) physical comfort(n=12) Psychological support (n=7) physical independence(n=5) pain(n=7) - Each one of the 40 questions gets a score from one to five at which one is the worst response and five is the best response. When the individual score of all questions are added together we get a total score that ranges from 40 to 200. | at the end of 24 hour after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| The duration of PACU stay | time from patient admission to the PACU till discharge from the PACU | 2 days postoperative |
| Duration of postoperative hospital stay | time from patient admission to the PACU till the hospital discharge admission to the PACU till the hospital discharge |
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Inclusion Criteria:
Exclusion Criteria:
-Uncooperative patients and patients with psychological problems.-
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| Name | Affiliation | Role |
|---|---|---|
| marwa M Medhat, MD | Zagazig University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aculty of Medicine,Zagazig University | Zagazig | Sharqia Province | 44519 | Egypt |
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| Fentanyl | Drug | Intravenous injection of 1.5 microgram/kg fentanyl will be given to the patient followed by induction agents (propofol 2mg/kg). |
|
| propofol and muscle relaxant (cisatracurium) | Drug | propofol 2mg/kg and muscle relaxant (cisatracurium) 0.15 mg/kg) |
|
| Propofol | Drug | propofol 2mg/kg |
|
| 2 days postoperative |
| Postoperative pain severity | (a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border). | recorded upon arrival to recovery room and at 1, 2, 4, 6 and 12hours postoperatively based |
| postoperative agitation score | Score Term Description
| immediately after extubation, on arrival to PACU, 10 minutes and 20 minutes after arrival to PACU: |
| ID | Term |
|---|---|
| D014147 | Tramadol |
| D000082 | Acetaminophen |
| D005283 | Fentanyl |
| D015742 | Propofol |
| C101584 | cisatracurium |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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