Emergence AgitationPhase 4NCT03179293
Transition to Propofol After Sevoflurane Anaesthesia to Prevent Emergence Agitation
A Phase 4 study testing Propofol and Normal saline in people with Emergence Agitation, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of this randomized double-blinded study is to determine whether transition to propofol for 3 min at the end of sevoflurane anaesthesia reduces the incidence of EA in children undergoing genito-urinary paediatric surgeries. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Emergence Agitation
- What is being tested?
- Propofol and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2017to 1 Jun 2018
- Phase
- Phase 4
- 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 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children Aged 3 - 8 years
- ASA (I - II)
- Genito-urinary Surgeries: hernia, varicocele, etc.
Who cannot join
- Patients or parental refusal
- Allergy to Propofol or egg products; or a family history of malignant hyperthermia
- Operating time more than 60 minutes
- Performance of any other procedure under the same anaesthetic
- Presence of co-morbidities or congenital anomalies
- mental disease, neurologic disease, treatment with sedatives, full stomach, or indication for rapid sequence induction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transition to Propofol After Sevoflurane Anaesthesia to Prevent Emergence Agitation in Genito-urinary Paediatric Surgeries
The aim of this randomized double-blinded study is to determine whether transition to propofol for 3 min at the end of sevoflurane anaesthesia reduces the incidence of EA in children undergoing genito-urinary paediatric surgeries.
- Conditions
- Emergence Agitation
- Being tested
- Propofol, Normal saline
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
propofol 1 mg/kg IV bolus will be given to the patient with a further 2 mg/kg administered manually over the next 3 min prior to the patient leaving the OR
Normal salineDrug
Normal saline will be administered manually over the next 3 min prior to the patient leaving the OR
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Active comparator | propofol 1 mg/kg IV bolus will be given to the patient with a further 2 mg/kg administered manually over the next 3 min prior to the patient leaving the OR Receives: Drug: Propofol |
| Control | Placebo comparator | Normal saline will be administered IV over the next 3 min prior to the patient leaving the OR Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergence Agitation
The incidence of EA according to the Watcha scale (defined as a score ≥3 at any time in the 30 min after emergence)
Measured: 30 min after emergence
Emergence Agitation
The incidence of EA according to the Paediatric Emergence Anaesthesia Delirium (PAED) scale (defined as a score >12 at any time in the 30 min after emergence )
Measured: 30 min after emergence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2017
- Study start1 Jul 2017
- Primary completion1 Jun 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence AgitationStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Samy Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03179293
- Sponsor's protocol ID
- propofol after sevo
- Status last verified
- Nov 2018
- First submitted
- 3 Jun 2017
- Last updated
- 28 Nov 2018
- Results posted
- 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 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transition to Propofol After Sevoflurane Anaesthesia to Prevent Emergence Agitation in Genito-urinary Paediatric Surgeries
- ClinicalTrials.gov ID
- NCT03179293
- Acronym / sponsor ID
- propofol after sevo
- Conditions
- Emergence Agitation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 7 Jun 2017 (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 aim of this randomized double-blinded study is to determine whether transition to propofol for 3 min at the end of sevoflurane anaesthesia reduces the incidence of EA in children undergoing genito-urinary paediatric surgeries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Active comparator | Drug: Propofolpropofol 1 mg/kg IV bolus will be given to the patient with a further 2 mg/kg administered manually over the next 3 min prior to the patient leaving the OR |
| Control | Placebo comparator | Drug: Normal salineNormal saline will be administered IV over the next 3 min prior to the patient leaving the OR |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children Aged 3 - 8 years
- ASA (I - II)
- Genito-urinary Surgeries: hernia, varicocele, etc.
Key exclusion criteria (6 listed)
- Patients or parental refusal
- Allergy to Propofol or egg products; or a family history of malignant hyperthermia
- Operating time more than 60 minutes
- Performance of any other procedure under the same anaesthetic
- Presence of co-morbidities or congenital anomalies
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 |
|---|---|---|
| Propofolpropofol 1 mg/kg IV bolus will be given to the patient with a further 2 mg/kg administered manually over the next 3 min prior to the patient leaving the OR | Drug | Propofol |
| Normal salineNormal saline will be administered manually over the next 3 min prior to the patient leaving the OR | Drug | Control |
Primary outcome
Emergence Agitation
Time frame: 30 min after emergence
The incidence of EA according to the Watcha scale (defined as a score ≥3 at any time in the 30 min after emergence)
Emergence Agitation
Time frame: 30 min after emergence
The incidence of EA according to the Paediatric Emergence Anaesthesia Delirium (PAED) scale (defined as a score >12 at any time in the 30 min after emergence )
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
- Individual participant dataSharing planned: No
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Intracuff Dexmedetomidine Versus Alkalinized Lidocaine for Peri-Extubation Cough and Hemodynamic Responses in Elderly Patients
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propofol and Normal saline in people with Emergence Agitation, run by Assiut 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 28 Nov 2018. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Emergence Agitation (time frame: 30 min after emergence). The study lists 2 primary outcomes in all. 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 28 Nov 2018.