Preemptive Paracetamol Plus Tramadol and Preemptive FentanylEarly Phase 1NCT06561672
Paracetamol Plus Tramadol Versus Fentanyl As Preemptive Analgesia For Enhanced Recovery After Day Case Surgeries
A Early Phase 1 study testing tramadol plus paracetamol, Fentanyl and propofol and muscle relaxant (cisatracurium) in people with Preemptive Paracetamol Plus Tramadol and Preemptive Fentanyl, run by Zagazig University at 1 site in Egypt.
Trial summary
Implementation of enhanced recovery in day case surgeries using either preemptive intravenous paracetamol plus tramadol or preemptive intravenous fentanyl. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Preemptive Paracetamol Plus Tramadol and Preemptive Fentanyl
- What is being tested?
- tramadol plus paracetamol, Fentanyl and propofol and muscle relaxant (cisatracurium)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 20 Jun 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Aculty of Medicine,Zagazig University
Zagazig, Sharqia Province, 44519
About this study
Official title: Paracetamol Plus Tramadol Versus Fentanyl As Preemptive Analgesia For Enhanced Recovery
Implementation of enhanced recovery in day case surgeries using either preemptive intravenous paracetamol plus tramadol or preemptive intravenous fentanyl.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tramadol plus paracetamolDrug
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)
FentanylDrug
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)
PropofolDrug
propofol 2mg/kg
| Study group | Role | What they receive |
|---|---|---|
| tramadol plus paracetamol (T) | Experimental | Not described Receives: Drug: tramadol plus paracetamol; Drug: propofol and muscle relaxant (cisatracurium) |
| fentanyl(F) | Experimental | Not described Receives: Drug: Fentanyl; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at the end of 24 hour after surgery.
Secondary outcomes (4)
The duration of PACU stay
time from patient admission to the PACU till discharge from the PACU
Measured: 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
Measured: 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).
Measured: recorded upon arrival to recovery room and at 1, 2, 4, 6 and 12hours postoperatively based
postoperative agitation score
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
Measured: immediately after extubation, on arrival to PACU, 10 minutes and 20 minutes after arrival to PACU:
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion20 Mar 2025 (estimated)
- Study completion20 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preemptive Paracetamol Plus Tramadol and Preemptive FentanylStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Marwa Mohamed Medhat, Zagazig University
- Investigators
- marwa M Medhat, MD, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561672
- Sponsor's protocol ID
- 459
- Status last verified
- Aug 2024
- First submitted
- 15 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paracetamol Plus Tramadol Versus Fentanyl As Preemptive Analgesia For Enhanced Recovery
- ClinicalTrials.gov ID
- NCT06561672
- Acronym / sponsor ID
- 459
- Keywords
- paracetamol ,tramadol , fentanyl, day case surgeries
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 20 Mar 2025 (estimated)
- Study completion
- 20 Jun 2025 (estimated)
- First posted
- 20 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tramadol plus paracetamol (T) | Experimental | Drug: tramadol plus paracetamol, Drug: propofol and muscle relaxant (cisatracurium) |
| fentanyl(F) | Experimental | Drug: Fentanyl, Drug: Propofol |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tramadol plus paracetamolIntravenous 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 | tramadol plus paracetamol (T) |
| FentanylIntravenous injection of 1.5 microgram/kg fentanyl will be given to the patient followed by induction agents (propofol 2mg/kg). | Drug | fentanyl(F) |
| propofol and muscle relaxant (cisatracurium)propofol 2mg/kg and muscle relaxant (cisatracurium) 0.15 mg/kg) | Drug | tramadol plus paracetamol (T) |
| Propofolpropofol 2mg/kg | Drug | fentanyl(F) |
Primary outcome
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.
4 secondary outcomes
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:
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
marwa M Medhat, MD principal investigator
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing tramadol plus paracetamol, Fentanyl and propofol and muscle relaxant (cisatracurium) in people with Preemptive Paracetamol Plus Tramadol and Preemptive Fentanyl, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enhanced recovery score (time frame: at the end of 24 hour after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.