Recovery PeriodNCT06832683
Efficacy of Propofol-Ketamine and Sevoflurane in Children Undergoing Magnetic Resonance Imaging
A study testing Sevoflurane, Propofol and Ketamine in people with Recovery Period and Hypoxemia, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Magnetic resonance imaging (MRI) is becoming increasingly important in the diagnosis and follow-up of pediatric diseases. However, successful MRI requires complete and prolonged immobility, which can be challenging for young children and infants. Read more about this study
- Who is it for?
- Ages 3 months to 10 years
- Conditions the study is for
- Recovery Period, Hypoxemia, Patient Safety
- What is being tested?
- Sevoflurane, Propofol and Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jun 2025to 8 Sep 2025
- 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 3 months to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 3 months to 10 years.
- Classified as ASA I-II according to the American Society of Anesthesiologists (ASA) classification.
- Patients scheduled for MRI at Kocaeli City Hospital MRI unit.
Who cannot join
- Families or children who do not consent to participate in the study.
- Patients with allergies to ketamine, propofol, midazolam, or sevoflurane.
- Patients with known pulmonary or cardiac diseases.
- Patients with known congenital craniofacial or neck anomalies.
- Patients dependent on oxygen therapy.
- Patients with a recent respiratory tract infection within the past 2 weeks.
Show all 12Show fewer
- Patients requiring tracheal intubation, laryngeal mask, or ventilator support.
- Patients at risk of upper airway obstruction.
- Patients with behavioral problems.
- Patients with gastroesophageal reflux disease.
- Patients with lethargy, stupor, or unresponsiveness to stimuli due to any cause
- Patients with active use of antiepileptic or antipsychotic medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficacy of Intravenous Propofol-Ketamine and Sevoflurane Administered Via Face Mask in Children Undergoing Magnetic Resonance Imaging: A Prospective, Randomized, Parallel-Group Study
Magnetic resonance imaging (MRI) is becoming increasingly important in the diagnosis and follow-up of pediatric diseases. However, successful MRI requires complete and prolonged immobility, which can be challenging for young children and infants. To overcome this challenge, various anesthesia techniques are employed by anesthesiologists. The ideal anesthesia method for children during MRI should be both safe and enable rapid recovery, allowing the child to remain still during the procedure while minimizing risks during the recovery period.
**Sevoflurane has become a popular choice for this purpose due to its rapid onset, limited respiratory side effects at low concentrations, reduced airway irritation, and hemodynamic stability. However, propofol and ketamine, used as an alternative sedation method, are also being increasingly utilized during these procedures. The major side effects of propofol include respiratory depression, apnea, loss of protective reflexes, and hemodynamic instability. To minimize these side effects, some experts recommend the combined use of propofol and ketamine. This combination provides effective sedation while also contributing to a reduction in side effects.
In this context, the aim of our study is to compare the efficacy of intravenous propofol and ketamine with sevoflurane administered via a face mask during pediatric MRI.
Read the detailed description
Participants were randomized in a 1:1 ratio using a computer program, stratified based on MRI durations, and divided into two groups: Group S and Group P.
All participants received intravenous midazolam at a dose of 0.05 mg/kg (max 2 mg). During MRI, all patients were monitored with pulse oximetry and end-tidal CO2, and procedural oxygen masks (POM) were applied to deliver oxygen at a flow rate of 5 L/min. For Group S, 8% sevoflurane was administered for induction via the procedural oxygen mask for 2 minutes through the external output of the anesthesia machine. The concentration was then reduced to 2%. If any undesired movements occurred, they were recorded, and the sevoflurane concentration was increased by 0.5%.
In Group P, 1 mg/kg ketamine was administered intravenously, followed by 1.0 mg/kg propofol as a bolus. In the event of undesired movements, an additional 0.5 mg/kg of propofol was administered, and all additional doses were recorded. The target sedation level was set at a Ramsay Sedation Scale (RSS) score of 4, which was maintained throughout the procedure. At the end of the procedure, patients were awakened with verbal and tactile stimulation. Once an RSS score of 2 was achieved, they were transferred to the Post-Anesthetic Care Unit (PACU).
Vital signs, procedure durations, and drug doses were recorded for each patient during the procedure. All clinical decisions regarding the patients were made by the attending anesthesiologist. In the PACU, patients with a modified Aldrete score of 10 were deemed eligible for discharge. After discharge approval, all patients were observed in the outpatient unit for 1 hour. The study concluded at this point.
- Conditions
- Recovery Period, Hypoxemia, Patient Safety
- Being tested
- Sevoflurane, Propofol, Ketamine
- Keywords
- recovery period, Hypoxemia, Patient Safety, Sedation, Moderate, propofol, ketamine, sevoflurane
- Medical subject headings
- Hypoxia, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Also called Group S
For Group S, 8% sevoflurane was administered for induction via the procedural oxygen mask for 2 minutes through the external output of the anesthesia machine. The concentration was then reduced to 2%. If any undesired movements occurred, they were recorded, and the sevoflurane concentration was increased by 0.5%.
PropofolDrug
Also called Group P
In Group P, 1.0 mg/kg propofol as a bolus. In the event of undesired movements, an additional 0.5 mg/kg of propofol was administered, and all additional doses were recorded.
KetamineDrug
Also called Group P
In Group P, 1 mg/kg, single dose ketamine was administered intravenously and all additional doses were recorded.
| Study group | Role | What they receive |
|---|---|---|
| Group P | Active comparator | Intravenous propofol and ketamine will be administered to the patients in this group. Receives: Drug: Propofol; Drug: Ketamine |
| Group S | Active comparator | Sevoflurane will be administered via a procedural oxygen mask to the patients in this group. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery time
Recovery time was defined as the duration (measured in minutes) from the end of the MRI scan until the patient reached a Ramsay Sedation Scale (RSS) score of 2. The Ramsay Sedation Scale ranges from 1 (awake) to 6 (deep sedation), with higher scores indicating deeper sedation. In this study, an RSS score of 2 was considered the criterion for sufficient recovery.
Measured: From the end of the MRI scan until the patient reaches a Ramsay Sedation Scale (RSS) score of 2, assessed for a maximum of 60 minutes.
Secondary outcomes (9)
Discharge time
Discharge time was defined as the duration (measured in minutes) from the completion of the procedure until the child's Modified Aldrete Score reached 10, indicating readiness for discharge. The Modified Aldrete Score ranges from 0 to 10, with higher scores representing better recovery status. A score of 10 was considered the criterion for discharge readiness in this study.
Measured: From the completion of the procedure until the child's Modified Aldrete Score reaches 10, assessed for a maximum of 60 minutes.
Anesthesia duration
Anesthesia duration was defined as the time (measured in minutes) from the start of anesthesia induction until the completion of the MRI procedure.
Measured: From the start of anesthesia induction to the completion of the MRI procedure, assessed for a maximum of 60 minutes.
Incidence of hypoxemia
Incidence of hypoxemia during sedation (defined as SpO2 < 93%).
Measured: Continuous SpO2 monitoring will be performed throughout the procedure]
Number of hypoxemia episodes
a new episode was recorded if SpO2 fell below 93% again after reaching SpO2 ≥ 93% for at least 30 seconds
Measured: Continuous SpO2 monitoring will be performed throughout the procedure
Duration of hypoxemia
defined as the time to reach SpO2 ≥ 93%
Measured: Continuous SpO2 monitoring will be performed throughout the procedure
Minimum SpO2
observed during the procedure
Measured: Continuous SpO2 monitoring will be performed throughout the procedure]
airway management
Procedure interruptions due to airway interventions during the procedure (chin lift, jaw thrust, mask ventilation, need for suctioning).
Measured: Interventions related to airway management causing interruptions during the procedure
Additional anesthetic intervention
Additional anesthetic intervention due to undesired movements disrupting image quality and causing interruptions in the procedure.
Measured: during procedure
Image quality
Image quality was evaluated by a radiologist who was not involved in the imaging process, using a 10-point analog scale (0: unacceptable, 5: diagnosis not possible, 8: acceptable, 10: excellent).
Measured: immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start19 Jun 2025
- Primary completion8 Sep 2025
- Study completion8 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Recovery PeriodStudies 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
- Model description
- A Prospective, Randomized, Parallel-Group Study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bedirhan Günel, Kocaeli City Hospital
- Investigators
- Bedirhan Günel, MD, Principal investigator, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832683
- Sponsor's protocol ID
- KSH-ANREA-BG-04
- Status last verified
- Sep 2025
- First submitted
- 1 Feb 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Personal data and study data will not be shared.
Publications
Schmitz A, Weiss M, Kellenberger C, O'Gorman Tuura R, Klaghofer R, Scheer I, Makki M, Sabandal C, Buehler PK. Sedation for magnetic resonance imaging using propofol with or without ketamine at induction in pediatrics-A prospective randomized double-blinded study. Paediatr Anaesth. 2018 Mar;28(3):264-274. doi: 10.1111/pan.13315. Epub 2018 Jan 27.
PubMed 29377404Ogurlu M, Orhan ME, Bilgin F, Sizlan A, Yanarates O, Yilmaz N. Efficacy of different concentrations of sevoflurane administered through a face mask for magnetic resonance imaging in children. Paediatr Anaesth. 2010 Dec;20(12):1098-104. doi: 10.1111/j.1460-9592.2010.03438.x.
PubMed 21199119
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Intravenous Propofol-Ketamine and Sevoflurane Administered Via Face Mask in Children Undergoing Magnetic Resonance Imaging: A Prospective, Randomized, Parallel-Group Study
- ClinicalTrials.gov ID
- NCT06832683
- Acronym / sponsor ID
- KSH-ANREA-BG-04
- Conditions
- Recovery Period, Hypoxemia, Patient Safety
- Keywords
- recovery period, Hypoxemia, Patient Safety, Sedation, Moderate, propofol, ketamine, sevoflurane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Kocaeli City HospitalOther government
- Study start
- 19 Jun 2025 (actual)
- Primary completion
- 8 Sep 2025 (actual)
- Study completion
- 8 Sep 2025 (actual)
- First posted
- 18 Feb 2025 (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.
Magnetic resonance imaging (MRI) is becoming increasingly important in the diagnosis and follow-up of pediatric diseases. However, successful MRI requires complete and prolonged immobility, which can be challenging for young children and infants. To overcome this challenge, various anesthesia techniques are employed by anesthesiologists. The ideal anesthesia method for children during MRI should be both safe and enable rapid recovery, allowing the child to remain still during the procedure while minimizing risks during the recovery period.
**Sevoflurane has become a popular choice for this purpose due to its rapid onset, limited respiratory side effects at low concentrations, reduced airway irritation, and hemodynamic stability. However, propofol and ketamine, used as an alternative sedation method, are also being increasingly utilized during these procedures. The major side effects of propofol include respiratory depression, apnea, loss of protective reflexes, and hemodynamic instability. To minimize these side effects, some experts recommend the combined use of propofol and ketamine. This combination provides effective sedation while also contributing to a reduction in side effects.
In this context, the aim of our study is to compare the efficacy of intravenous propofol and ketamine with sevoflurane administered via a face mask during pediatric MRI.
Detailed description
Participants were randomized in a 1:1 ratio using a computer program, stratified based on MRI durations, and divided into two groups: Group S and Group P.
All participants received intravenous midazolam at a dose of 0.05 mg/kg (max 2 mg). During MRI, all patients were monitored with pulse oximetry and end-tidal CO2, and procedural oxygen masks (POM) were applied to deliver oxygen at a flow rate of 5 L/min. For Group S, 8% sevoflurane was administered for induction via the procedural oxygen mask for 2 minutes through the external output of the anesthesia machine. The concentration was then reduced to 2%. If any undesired movements occurred, they were recorded, and the sevoflurane concentration was increased by 0.5%.
In Group P, 1 mg/kg ketamine was administered intravenously, followed by 1.0 mg/kg propofol as a bolus. In the event of undesired movements, an additional 0.5 mg/kg of propofol was administered, and all additional doses were recorded. The target sedation level was set at a Ramsay Sedation Scale (RSS) score of 4, which was maintained throughout the procedure. At the end of the procedure, patients were awakened with verbal and tactile stimulation. Once an RSS score of 2 was achieved, they were transferred to the Post-Anesthetic Care Unit (PACU).
Vital signs, procedure durations, and drug doses were recorded for each patient during the procedure. All clinical decisions regarding the patients were made by the attending anesthesiologist. In the PACU, patients with a modified Aldrete score of 10 were deemed eligible for discharge. After discharge approval, all patients were observed in the outpatient unit for 1 hour. The study concluded at this point.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A Prospective, Randomized, Parallel-Group Study
| Arm | Type | Receives |
|---|---|---|
| Group P | Active comparator | Drug: Propofol, Drug: KetamineIntravenous propofol and ketamine will be administered to the patients in this group. |
| Group S | Active comparator | Drug: SevofluraneSevoflurane will be administered via a procedural oxygen mask to the patients in this group. |
Who may qualify
- Ages
- 3 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Ages 3 months to 10 years.
- Classified as ASA I-II according to the American Society of Anesthesiologists (ASA) classification.
- Patients scheduled for MRI at Kocaeli City Hospital MRI unit.
Key exclusion criteria (12 listed)
- Families or children who do not consent to participate in the study.
- Patients with allergies to ketamine, propofol, midazolam, or sevoflurane.
- Patients with known pulmonary or cardiac diseases.
- Patients with known congenital craniofacial or neck anomalies.
- Patients dependent on oxygen 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 |
|---|---|---|
| SevofluraneAlso: Group SFor Group S, 8% sevoflurane was administered for induction via the procedural oxygen mask for 2 minutes through the external output of the anesthesia machine. The concentration was then reduced to 2%. If any undesired movements occurred, they were recorded, and the sevoflurane concentration was increased by 0.5%. | Drug | Group S |
| PropofolAlso: Group PIn Group P, 1.0 mg/kg propofol as a bolus. In the event of undesired movements, an additional 0.5 mg/kg of propofol was administered, and all additional doses were recorded. | Drug | Group P |
| KetamineAlso: Group PIn Group P, 1 mg/kg, single dose ketamine was administered intravenously and all additional doses were recorded. | Drug | Group P |
Primary outcome
Recovery time
Time frame: From the end of the MRI scan until the patient reaches a Ramsay Sedation Scale (RSS) score of 2, assessed for a maximum of 60 minutes.
Recovery time was defined as the duration (measured in minutes) from the end of the MRI scan until the patient reached a Ramsay Sedation Scale (RSS) score of 2. The Ramsay Sedation Scale ranges from 1 (awake) to 6 (deep sedation), with higher scores indicating deeper sedation. In this study, an RSS score of 2 was considered the criterion for sufficient recovery.
9 secondary outcomes
Discharge time
Time frame: From the completion of the procedure until the child's Modified Aldrete Score reaches 10, assessed for a maximum of 60 minutes.
Anesthesia duration
Time frame: From the start of anesthesia induction to the completion of the MRI procedure, assessed for a maximum of 60 minutes.
Incidence of hypoxemia
Time frame: Continuous SpO2 monitoring will be performed throughout the procedure]
Number of hypoxemia episodes
Time frame: Continuous SpO2 monitoring will be performed throughout the procedure
Duration of hypoxemia
Time frame: Continuous SpO2 monitoring will be performed throughout the procedure
Minimum SpO2
Time frame: Continuous SpO2 monitoring will be performed throughout the procedure]
airway management
Time frame: Interventions related to airway management causing interruptions during the procedure
Additional anesthetic intervention
Time frame: during procedure
Image quality
Time frame: immediately after the procedure
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 10 Sep 2025.
- Background: PubMed 29377404Schmitz A, Weiss M, Kellenberger C, O'Gorman Tuura R, Klaghofer R, Scheer I, Makki M, Sabandal C, Buehler PK. Sedation for magnetic resonance imaging using propofol with or without ketamine at induction in pediatrics-A prospective randomized double-blinded study. Paediatr Anaesth. 2018 Mar;28(3):264-274. doi: 10.1111/pan.13315. Epub 2018 Jan 27.
- Background: PubMed 21199119Ogurlu M, Orhan ME, Bilgin F, Sizlan A, Yanarates O, Yilmaz N. Efficacy of different concentrations of sevoflurane administered through a face mask for magnetic resonance imaging in children. Paediatr Anaesth. 2010 Dec;20(12):1098-104. doi: 10.1111/j.1460-9592.2010.03438.x.
- Individual participant dataSharing planned: No. Personal data and study data will not be shared.
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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.
Bedirhan Günel, MD principal investigator
Kocaeli City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane, Propofol and Ketamine in people with Recovery Period and Hypoxemia, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
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 12 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 10 Sep 2025. 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 Turkey (Türkiye). 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?
Recovery time (time frame: From the end of the MRI scan until the patient reaches a Ramsay Sedation Scale (RSS) score of 2, assessed for a maximum of 60 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06832683, which also lists 2 linked publications.
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 10 Sep 2025.