Propofol Anesthesia in ChildrenNCT05081206
Comparison of the Manually Controlled Propofol Infusion and Target Controlled Infusion in Children
A study of Propofol Anesthesia in Children, run by University Children's Hospital at 1 site in Serbia.
Trial summary
Patients 1 to 8 years of age, American Society of Anesthesiologist score 1 and 2, planned for elective, one day surgery: inguinal hernia repair, hydrocele surgery, testis retention surgery, varicocele and phimosis surgery, and parents or legal guardians will be asked to sign written informed consent for participation… Read more about this study
- Who is it for?
- Ages 1 year to 8 years
- Conditions the study is for
- Propofol Anesthesia in Children
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteSerbia
- Study dates
- 18 Oct 2021to 24 Jan 2022
- Phase
- Interventional
- 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 1 year to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA score 1 and 2.
- Planned for elective, one day surgery: inguinal hernia repair, hydrocele surgery, testis retention surgery, varicocele and phimosis surgery,
- Signed written informed consent for participation in the study by parent and/or legal guardian.
Who cannot join
- Confirmed propofol allergies.
- Mitochondrial disease
- Disease of lipid and carbohydrate metabolism
- Neurological disorders
- Treated psychiatric comorbidities
- Hypertension.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Manually Controlled Propofol Infusion and Target Controlled Infusion Anesthesia for One Day Surgery in Pediatric Patients
Patients 1 to 8 years of age, American Society of Anesthesiologist score 1 and 2, planned for elective, one day surgery: inguinal hernia repair, hydrocele surgery, testis retention surgery, varicocele and phimosis surgery, and parents or legal guardians will be asked to sign written informed consent for participation in the study. Exclusion criteria will be: confirmed propofol allergies, mitochondrial disease, disease of lipid and carbohydrate metabolism, neurological disorders, treated psychiatric comorbidities, hypertension.
All participants will be randomly assigned to two groups: one in which manually controlled propofol infusion will be used (MC group) and the other with target controlled infusion (TC group). After anesthesia induction depth of anesthesia during surgery will be measured using bispectral index (BIS), continuously. As a part of routine monitoring noninvasive blood pressure monitoring will be measured, and recorded in three time points, as well as heart rate. Time will be measured from the moment when propofol infusion was stopped till tracheal extubating.
Read the detailed description
Prospective, randomized controlled study will be done at the University Children's Clinic. For the study ethical board approval was requested. Pediatric patients, planned for elective, one day surgery, requiring intubation with signed informed consent will be randomly assigned to two groups First in which manually controlled propofol infusion will be used (MC group) and the other with target controlled infusion (TC group).
All participants will be premedicated half an hour before anesthesia induction with midazolam orally in dose of 0.5mg/kg body weight. Intravenous cannula will be placed 20-30 minutes later, and participants will receive atropine in dose of 0,02mg/kg intravenously, and fentanyl 1mcg/kg intravenously. In the MC group participants will receive propofol bolus 2.5-3 mg/kg, for anesthesia induction and anesthesia maintenance will be done according to the Mc Farlan scheme. In TC group Pedfusor model will be used, with target concentration for anesthesia induction of 4 mcg/kg body weight and anesthesia maintenance of 3 mcg/kg. In all participants remifentanil in dose of 0.4mcg/kg/min will be used as analgesic, and cisatracurium 0.15mg/kg was muscle relaxant, for anesthesia induction. At the end of surgery, before remifentanil infusion is stopped, all patients will receive 0.5 mg/kg of ketorolac. If BIS values are out of the40-60 range during anesthesia, in MC group infusion rate will be changed and in TC group set plasma concentration (Cp) will be corrected. In case of heart rate increase or decrease for more than 20% compared to initial values, speed of remifentanil infusion will be decreased or increased, respectively. All participants will have standard monitoring during anesthesia: percutaneous saturation, end tidal concentration of carbon dioxide measurement, three channel electrocardiography, noninvasive blood pressure monitoring, and continuous BIS measurement. Propofol infusion will be stopped 5 minutes before expected end of surgery, and remifentanil infusion will be stopped at the end of surgery. Time will be measured from the moment when propofol infusion was stopped till tracheal extubating.
- Conditions
- Propofol Anesthesia in Children
- Being tested
- Propofol infusion via manually controlled pump., Propofol infusion via target controlled pump.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Propofol infusion via manually controlled pump.Drug
Patients will receive propofol bolus 2.5-3 mg/kg, for anesthesia induction and anesthesia maintenance was continued according to the Mc Farlan scheme, meaning continuous propofol infusion is used, with gradual reduction of the infusion speed in timely manner, depending on the duration of surgery: 15mg/kg/h...13mg/kg/h...11mg/kg/h...9mg/kg/h...6mg/kg/h.
Propofol infusion via target controlled pump.Drug
Pedfusor model was used for delivering target controlled plasma concentration, with target concentration for anesthesia induction of 4 mcg/kg body weight and then 3 mcg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Manually controlled | Experimental | Not described Receives: Drug: Propofol infusion via manually controlled pump. |
| Target controlled | Experimental | Not described Receives: Drug: Propofol infusion via target controlled pump. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depth of anesthesia comparison between two experimental groups.
Depth of anesthesia will be measured with continuous bispectral index and compared between two experimental groups.
Measured: From anesthesia induction till extubation, every minute up to 90 minutes.
Secondary outcomes (3)
Comparison of blood pressure between two experimental groups.
Blood pressure will be measured in three specified time points during anesthesia, and the values will be compared between two experimental groups.
Measured: At 0 and 20 minutes during anesthesia and 5 minutes after discontinuation of propofol infusion.
Comparison of heart rate between two experimental groups.
Heart rate will be measured in three specified time points during anesthesia, and the values will be compared between two experimental groups.
Measured: At 0 and 20 minutes during anesthesia and 5 minutes after discontinuation of propofol infusion.
Time to tracheal extubation comparison between two experimental groups.
Time to tracheal extubation will be measured after propofol infusion termination in both experimental groups and compared.
Measured: 5 to 15 minutes after discontinuation of propofol infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start18 Oct 2021
- Primary completion17 Jan 2022
- Study completion24 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Propofol Anesthesia in ChildrenStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irina Milojevic, University Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081206
- Sponsor's protocol ID
- TirsovaChildrensH
- Status last verified
- Jan 2022
- First submitted
- 10 Aug 2021
- Last updated
- 26 Jan 2022
- 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 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Manually Controlled Propofol Infusion and Target Controlled Infusion Anesthesia for One Day Surgery in Pediatric Patients
- ClinicalTrials.gov ID
- NCT05081206
- Acronym / sponsor ID
- TirsovaChildrensH
- Conditions
- Propofol Anesthesia in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University Children's HospitalUniversity, hospital or other
- Study start
- 18 Oct 2021 (actual)
- Primary completion
- 17 Jan 2022 (actual)
- Study completion
- 24 Jan 2022 (actual)
- First posted
- 18 Oct 2021 (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.
Patients 1 to 8 years of age, American Society of Anesthesiologist score 1 and 2, planned for elective, one day surgery: inguinal hernia repair, hydrocele surgery, testis retention surgery, varicocele and phimosis surgery, and parents or legal guardians will be asked to sign written informed consent for participation in the study. Exclusion criteria will be: confirmed propofol allergies, mitochondrial disease, disease of lipid and carbohydrate metabolism, neurological disorders, treated psychiatric comorbidities, hypertension.
All participants will be randomly assigned to two groups: one in which manually controlled propofol infusion will be used (MC group) and the other with target controlled infusion (TC group). After anesthesia induction depth of anesthesia during surgery will be measured using bispectral index (BIS), continuously. As a part of routine monitoring noninvasive blood pressure monitoring will be measured, and recorded in three time points, as well as heart rate. Time will be measured from the moment when propofol infusion was stopped till tracheal extubating.
Detailed description
Prospective, randomized controlled study will be done at the University Children's Clinic. For the study ethical board approval was requested. Pediatric patients, planned for elective, one day surgery, requiring intubation with signed informed consent will be randomly assigned to two groups First in which manually controlled propofol infusion will be used (MC group) and the other with target controlled infusion (TC group).
All participants will be premedicated half an hour before anesthesia induction with midazolam orally in dose of 0.5mg/kg body weight. Intravenous cannula will be placed 20-30 minutes later, and participants will receive atropine in dose of 0,02mg/kg intravenously, and fentanyl 1mcg/kg intravenously. In the MC group participants will receive propofol bolus 2.5-3 mg/kg, for anesthesia induction and anesthesia maintenance will be done according to the Mc Farlan scheme. In TC group Pedfusor model will be used, with target concentration for anesthesia induction of 4 mcg/kg body weight and anesthesia maintenance of 3 mcg/kg. In all participants remifentanil in dose of 0.4mcg/kg/min will be used as analgesic, and cisatracurium 0.15mg/kg was muscle relaxant, for anesthesia induction. At the end of surgery, before remifentanil infusion is stopped, all patients will receive 0.5 mg/kg of ketorolac. If BIS values are out of the40-60 range during anesthesia, in MC group infusion rate will be changed and in TC group set plasma concentration (Cp) will be corrected. In case of heart rate increase or decrease for more than 20% compared to initial values, speed of remifentanil infusion will be decreased or increased, respectively. All participants will have standard monitoring during anesthesia: percutaneous saturation, end tidal concentration of carbon dioxide measurement, three channel electrocardiography, noninvasive blood pressure monitoring, and continuous BIS measurement. Propofol infusion will be stopped 5 minutes before expected end of surgery, and remifentanil infusion will be stopped at the end of surgery. Time will be measured from the moment when propofol infusion was stopped till tracheal extubating.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manually controlled | Experimental | Drug: Propofol infusion via manually controlled pump. |
| Target controlled | Experimental | Drug: Propofol infusion via target controlled pump. |
Who may qualify
- Ages
- 1 year to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA score 1 and 2.
- Planned for elective, one day surgery: inguinal hernia repair, hydrocele surgery, testis retention surgery, varicocele and phimosis surgery,
- Signed written informed consent for participation in the study by parent and/or legal guardian.
Key exclusion criteria (6 listed)
- Confirmed propofol allergies.
- Mitochondrial disease
- Disease of lipid and carbohydrate metabolism
- Neurological disorders
- Treated psychiatric comorbidities
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 |
|---|---|---|
| Propofol infusion via manually controlled pump.Patients will receive propofol bolus 2.5-3 mg/kg, for anesthesia induction and anesthesia maintenance was continued according to the Mc Farlan scheme, meaning continuous propofol infusion is used, with gradual reduction of the infusion speed in timely manner, depending on the duration of surgery: 15mg/kg/h...13mg/kg/h...11mg/kg/h...9mg/kg/h...6mg/kg/h. | Drug | Manually controlled |
| Propofol infusion via target controlled pump.Pedfusor model was used for delivering target controlled plasma concentration, with target concentration for anesthesia induction of 4 mcg/kg body weight and then 3 mcg/kg. | Drug | Target controlled |
Primary outcome
Depth of anesthesia comparison between two experimental groups.
Time frame: From anesthesia induction till extubation, every minute up to 90 minutes.
Depth of anesthesia will be measured with continuous bispectral index and compared between two experimental groups.
3 secondary outcomes
Comparison of blood pressure between two experimental groups.
Time frame: At 0 and 20 minutes during anesthesia and 5 minutes after discontinuation of propofol infusion.
Comparison of heart rate between two experimental groups.
Time frame: At 0 and 20 minutes during anesthesia and 5 minutes after discontinuation of propofol infusion.
Time to tracheal extubation comparison between two experimental groups.
Time frame: 5 to 15 minutes after discontinuation of propofol infusion
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 26 Jan 2022.
- Individual participant dataSharing planned: No
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Extubation
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 study of Propofol Anesthesia in Children, run by University Children's Hospital at 1 site in Serbia.
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 26 Jan 2022. 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 Serbia. 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.
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?
Depth of anesthesia comparison between two experimental groups. (time frame: From anesthesia induction till extubation, every minute up to 90 minutes.). 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 26 Jan 2022.