Pruritus Caused by DrugPhase 3NCT06188546
Propofol for Prophylaxis of Morphine Induced Pruritis in Caesarean Section
A Phase 3 study testing Propofol in people with Pruritus Caused by Drug, run by Assiut University.
Trial summary
the goal of this randomized clinical trial is to find the optimum sub hypnotic dose of iv propofol that prevents the incidence of itching induced from intrathecal morphine used in spinal anesthesia in caesarean section operation. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pruritus Caused by Drug
- What is being tested?
- Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 1 Mar 2025
- Phase
- Phase 3
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The study is scheduled for women undergoing elective caesarean section under spinal anesthesia.
- The subject is ≥ 20 years and ≤ 40 years.
- No obvious abnormalities in preoperative ECG, blood routine, electrolytes, and other tests.
- ASA class 1-2.
Who cannot join
- Patients who had a known allergy to propofol, morphine, or bupivacaine.
- Those with preexisting pruritus caused by pregnancy, a coexisting skin disorder, or other pruritogenic systemic diseases.
- Patients with a contraindication to spinal anaesthesia
- Failed block
- Need of extra sedation intra-operative
- Positive history for asthma or COPD.
- Patient refusal
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Administration of Propofol for Prophylaxis of Intrathecal Morphine Induced Pruritus in Caesarean Section
the goal of this randomized clinical trial is to find the optimum sub hypnotic dose of iv propofol that prevents the incidence of itching induced from intrathecal morphine used in spinal anesthesia in caesarean section operation. the main questions it aim to answer are the number of patients complained of pruritus in the first 24 hours post operative period and the severity of the pruritus. participants will be divided into 4 groups. 1st group receives 0 mg of propofol , 2nd receives 10 mg , 3rd receives 20 mg and the 4th receives 30 mg.
- Conditions
- Pruritus Caused by Drug
- Being tested
- Propofol
- Keywords
- morphine induced pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
trying different dosages of propofol 10mg/ml IV to determine the prophylactic dose for morphine induced pruritis
| Study group | Role | What they receive |
|---|---|---|
| Group 0 | Placebo comparator | Will receive no drugs for pruritis prophylaxis Receives: Drug: Propofol |
| Group 1 | Active comparator | Will receive 1ml of propofol 10 mg/ml Receives: Drug: Propofol |
| Group 2 | Active comparator | Will receive 2 ml of propofol 10mg/ml Receives: Drug: Propofol |
| Group 3 | Active comparator | Will receive 3 ml of propofol 10mg/ml Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants complained of pruritus in the first 24hr post operative period
Measured: first 24 hours post operative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start1 Jan 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pruritus Caused by DrugStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sohila Khaled Mohamed Hassan, Assiut University
- Investigators
- Zein Zarea, MD, Study chair, Assiut UniversityDiab Fuad Hetta, MD, Study director, South Egypt's cancer instituteRania Mohamed Abdelemam, MD, Study director, South Egypt's cancer institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188546
- Sponsor's protocol ID
- propofol for pruritis
- Status last verified
- Dec 2023
- First submitted
- 19 Dec 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Propofol for Prophylaxis of Intrathecal Morphine Induced Pruritus in Caesarean Section
- ClinicalTrials.gov ID
- NCT06188546
- Acronym / sponsor ID
- propofol for pruritis
- Conditions
- Pruritus Caused by Drug
- Keywords
- morphine induced pruritus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 3 Jan 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.
the goal of this randomized clinical trial is to find the optimum sub hypnotic dose of iv propofol that prevents the incidence of itching induced from intrathecal morphine used in spinal anesthesia in caesarean section operation. the main questions it aim to answer are the number of patients complained of pruritus in the first 24 hours post operative period and the severity of the pruritus. participants will be divided into 4 groups. 1st group receives 0 mg of propofol , 2nd receives 10 mg , 3rd receives 20 mg and the 4th receives 30 mg.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 0 | Placebo comparator | Drug: PropofolWill receive no drugs for pruritis prophylaxis |
| Group 1 | Active comparator | Drug: PropofolWill receive 1ml of propofol 10 mg/ml |
| Group 2 | Active comparator | Drug: PropofolWill receive 2 ml of propofol 10mg/ml |
| Group 3 | Active comparator | Drug: PropofolWill receive 3 ml of propofol 10mg/ml |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The study is scheduled for women undergoing elective caesarean section under spinal anesthesia.
- The subject is ≥ 20 years and ≤ 40 years.
- No obvious abnormalities in preoperative ECG, blood routine, electrolytes, and other tests.
- ASA class 1-2.
Key exclusion criteria (7 listed)
- Patients who had a known allergy to propofol, morphine, or bupivacaine.
- Those with preexisting pruritus caused by pregnancy, a coexisting skin disorder, or other pruritogenic systemic diseases.
- Patients with a contraindication to spinal anaesthesia
- Failed block
- Need of extra sedation intra-operative
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 |
|---|---|---|
| Propofoltrying different dosages of propofol 10mg/ml IV to determine the prophylactic dose for morphine induced pruritis | Drug | Group 0, Group 1, Group 2, Group 3 |
Primary outcome
number of participants complained of pruritus in the first 24hr post operative period
Time frame: first 24 hours post operative period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Pruritus Caused by Drug
Active, not recruitingPhase 2
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)
Primary Sclerosing Cholangitis
Active, not recruitingPhase 2
A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis
Primary Biliary Cholangitis, PBC
RecruitingPhase 4
Comparison of Pruritus Incidence After Intrathecal Morphine 0.1 vs 0.2 mg in Cesarean Section
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RecruitingPhase 1
Ondansetron Use for Preventing Pruritus in Patients Undergoing Cesarean Section
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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.
Zein Zarea, MD study chair
Assiut University
Diab Fuad Hetta, MD study director
South Egypt's cancer institute
Rania Mohamed Abdelemam, MD study director
South Egypt's cancer institute
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Propofol in people with Pruritus Caused by Drug, run by Assiut University.
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 4 inclusion and 7 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 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Sohila K Hassan, MBBCH (201010328326, khaledsohila@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of participants complained of pruritus in the first 24hr post operative period (time frame: first 24 hours post operative period). 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 3 Jan 2024.