Paracetamol Plus Tramadol Versus Fentanyl As Preemptive Analgesia For Enhanced Recovery After Day Case Surgeries
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: tramadol plus paracetamol, Fentanyl, propofol and muscle relaxant (cisatracurium), Propofol.
- Who it may be relevant to
- Registry conditions: Preemptive Paracetamol Plus Tramadol and Preemptive Fentanyl. Basic parameters: 21 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Paracetamol Plus Tramadol Versus Fentanyl As Preemptive Analgesia For Enhanced Recovery
Overview
Implementation of enhanced recovery in day case surgeries using either preemptive intravenous paracetamol plus tramadol or preemptive intravenous fentanyl.
Detailed description
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.
Interventions
- Drug tramadol plus paracetamol
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) - Drug Fentanyl
Intravenous injection of 1.5 microgram/kg fentanyl will be given to the patient followed by induction agents (propofol 2mg/kg). - Drug propofol and muscle relaxant (cisatracurium)
propofol 2mg/kg and muscle relaxant (cisatracurium) 0.15 mg/kg) - Drug Propofol
propofol 2mg/kg
Primary outcome measures
- Enhanced recovery score [Time frame: at the end of 24 hour after surgery.]
Secondary outcome measures (4)
- The duration of PACU stay [Time frame: 2 days postoperative]
- Duration of postoperative hospital stay [Time frame: 2 days postoperative]
- Postoperative pain severity [Time frame: recorded upon arrival to recovery room and at 1, 2, 4, 6 and 12hours postoperatively based]
- postoperative agitation score [Time frame: immediately after extubation, on arrival to PACU, 10 minutes and 20 minutes after arrival to PACU:]
Eligibility criteria
Inclusion criteria
- Patients scheduled for day case surgeries.
- Patient acceptance to be included into the study.
- Both sex.
- Patients with ASA physical status I, II.
- BMI 25 - 30 kg m-2.
- Duration of surgery from 1-2 hours
Exclusion criteria
-Uncooperative patients and patients with psychological problems.-
- Patients with liver or renal impairment.
- Patients with history of allergy to drug used in the study.
- Patients with chronic pain.
- Patient on pain therapy.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Aculty of Medicine,Zagazig University — Zagazig
Identifiers
NCT: NCT06561672 · 459