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Enrolling by Invitation

NCT Number: NCT06561672

Paracetamol Plus Tramadol Versus Fentanyl As Preemptive Analgesia For Enhanced Recovery After Day Case Surgeries

Implementation of enhanced recovery in day case surgeries using either preemptive intravenous paracetamol plus tramadol or preemptive intravenous fentanyl.

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Key information

Conditions

Preemptive Paracetamol Plus Tramadol and Preemptive Fentanyl

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Aculty of Medicine,Zagazig University

Zagazig, Sharqia Province, 44519, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

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

Primary outcomes

  1. Enhanced recovery score

    Time frame: at the end of 24 hour after surgery.

    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.

Secondary outcomes

  1. The duration of PACU stay

    Time frame: 2 days postoperative

    time from patient admission to the PACU till discharge from the PACU

  2. Duration of postoperative hospital stay

    Time frame: 2 days postoperative

    time from patient admission to the PACU till the hospital discharge admission to the PACU till the hospital discharge

  3. Postoperative pain severity

    Time frame: recorded upon arrival to recovery room and at 1, 2, 4, 6 and 12hours postoperatively based

    (a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border).

  4. postoperative agitation score

    Time frame: immediately after extubation, on arrival to PACU, 10 minutes and 20 minutes after arrival to PACU:

    Score Term Description

    • 4 Combative Overtly combative, violent, immediate danger to staff
    • 3 Very agitated Pulls or removes tubes (s) or catheter(s); aggressive
    • 2 Agitated Frequent non-purposeful movement
    • 1 Restless Anxious, but not aggressive or vigorous 0 Alert and calm
    • 1 Drowsy Not fully alert but has sustained awakening (eye opening or eye contact) to voice (< 10 seconds)
    • 2 Light sedation Briefly awaken with eye contact to voice (> 10 seconds)
    • 3 Moderate sedation Movement or eye opening to voice (but no eye contact)-4 Deep sedation No response to voice, but movement or eye opening to physical stimulation
    • 5 Unarousable No response to voice or physical stimulation

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Paracetamol Plus Tramadol Versus Fentanyl As Preemptive Analgesia For Enhanced Recovery

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 20, 2024
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.