Invasive CancerPhase 2/3NCT05636566
Comparing TIVA Using Propofol or Dexmedetomidine Versus Sevoflurane During Anaesthesia of Children Undergoing Bone-Marrow Aspiration
A Phase 2/3 study testing Sevoflurane, Propofol infusion for maintance and Dexmedetomidine in people with Invasive Cancer and Pediatric Cancer, run by Alexandria University at 1 site in Egypt.
Trial summary
No doubt that children facing surgical procedures are subjected to perioperative distressing, anxious and worrying periods. Several factors included; parental deprivation, anxiety, previously mismanaged experience and anticipating pain from the procedure itself weather diagnostic or curative. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Invasive Cancer, Pediatric Cancer
- What is being tested?
- Sevoflurane, Propofol infusion for maintance and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2022to 25 Oct 2022
- Phase
- Phase 2/3
- 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients aged 3-12 years.
- both sexes
- ASA physical status I and II
Who cannot join
- Patients with identified allergy to the study medications
- with recognized lipid or carbohydrate deranged metabolism
- cardiac dysrhythmias
- congenital heart diseases
- cardiomyopathy
- significant organ dysfunction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between TIVA Using Propofol or Dexmedetomidine Versus Sevoflurane During Anaesthesia of Children Undergoing Bone-Marrow Aspiration
No doubt that children facing surgical procedures are subjected to perioperative distressing, anxious and worrying periods. Several factors included; parental deprivation, anxiety, previously mismanaged experience and anticipating pain from the procedure itself weather diagnostic or curative. Anaesthetic goals should focus at alleviating these unfavorable events that may exacerbate the inevitable associated neurohormal stress response with its injurious effects on the course of the procedure. Moreover, it likely to extend beyond the surgical procedure predisposing these vulnerable group of patients to psychological trauma and chronic behavioral changes.
Bone marrow aspiration (BMA) is a frequent procedure that necessitate a meticulous anaesthetic plane that entails rapid non-traumatic induction together with adequate pain free maintenance and instant smooth recovery after a short time practice. Total intravenous anaesthesia (TIVA) had emerged as alternative anaesthetic technique to inhalational anaesthesia for conscious sedation in BMA cited by many authors.
Read more
Propofol a popular anaesthetic/ sedative with a rapid onset, short duration and smooth recovery of consciousness and psychomotor functions with no cumulation. However it is poorly analgesic, depresses respiration and there is a possibility of loss of muscle tone leading to airway obstruction .
Dexmedetomidine is a greatly active α2 adrenergic agonist with a valuable anaesthetic- analgesic saving effects. It augments sedation, hypnosis and preservation of muscle tone with negligible respiratory depression and hemodynamic derangements.
The purpose of the current study is to compare between effects of TIVA using propofol or dexmedetomedine versus sevoflurane for maintenance of anaesthesia in children undergoing bone marrow aspiration.
Read the detailed description
Background: although bone marrow aspiration in children is a familiar short duration procedure, nearly 65% of patients develop sever anxiety that may extend more beyond, up to chronic postoperative behavioral changes. Consequently, the objectives of any related anaesthetic technique is to afford smooth non-traumatic induction with safe maintenance and rapid recovery. The rational of the present study is to compare between TIVA using propofol or dexmedetomedine and sevoflurane for maintenance of anaesthesia in children scheduled for bone marrow aspiration.
Patients and methods: 60 child aged 3-12 years with ASA physical status I and II planned for elective bone marrow biopsy and aspiration were enrolled randomly into 3 groups 20 child each; group(S): received sevoflurane- oxygen for induction and sevoflurane with fentanyl infusion for maintenance of anaesthesia. Group (P): received propofol for induction followed by propofol-fentanyl infusions for maintenance of anaesthesia. Group (D): received dexmedetomedine infusion for induction followed by dexmedetomedine-fentanyl infusions for maintenance of anaesthesia. The primary endpoint was postoperative sedation score on arrival to the post anaesthetic care unit (PACU) after surgery. Secondary outcomes included procedure duration, hemodynamic variables, parents and surgeons satisfaction and incidences of any adverse events.
- Conditions
- Invasive Cancer, Pediatric Cancer
- Being tested
- Sevoflurane, Propofol infusion for maintance, Dexmedetomidine
- Keywords
- Dex-Profol, sevoflurane
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
inhalational anaesthesia for maintenance
Propofol infusion for maintanceDrug
propofol infusion after induction for maintenance of anaesthesia
DexmedetomidineDrug
0.5 mic /kg dexmedetomedine is injected after induction of anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| Group (S) | Active comparator | sevoflurane inhalational anaesthesia for induction, then sevoflurane and fentanyl infusion for maintenance , Receives: Drug: Sevoflurane |
| Group P | Active comparator | propofol infusion for induction afterward propofol and fentanyl infusions for maintenance of anaesthesia Receives: Drug: Propofol infusion for maintance |
| Group D | Active comparator | dexmedetomedine infusion for induction after that dexmedetomedine and fentanyl infusions for maintenance Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
sedation score
indicator for post operative alertness, . Sedation level: Agitated = 4, Awake= 3, Drowsy= 2, Asleep= 1. A sedation score of 3 \& above was considered as unsatisfactory while 1 \& 2 is considered to be satisfactory.
Measured: immediately postoperative
Secondary outcomes (1)
time for spontenous eye opening
assessement of the immediate time of recovery
Measured: immediately postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start15 Feb 2022
- Primary completion15 Sep 2022
- Study completion25 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive CancerStudies of the same condition, open and under way.
- More trials run by Alexandria 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sixty patients were randomized and assigned into 3 groups (n=20) each, using sealed envelope technique: * Group (S): received sevoflurane- oxygen for induction and sevoflurane with fentanyl (Fentanyl, Janssen-Cilag, Germany) infusion for maintenance of anaesthesia. * Group (P): received propofol (Diprivan, Astra Zeneca, Wedel, Germany) for induction followed by propofol-fentanyl infusions for maintenance of anaesthesia. * Group (D): received dexmedetomedine (Precedex, Dexmedetomedine HCL inj.,Hospira, Inc.,Lacke Forest, USA) infusion for induction followed by dexmedetomedine-fentanyl infusions for maintenance of anaesthesia. All solutions were prepared by a team member not participating in data recording of the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636566
- Sponsor's protocol ID
- 0305414
- Status last verified
- Feb 2022
- First submitted
- 18 Nov 2022
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between TIVA Using Propofol or Dexmedetomidine Versus Sevoflurane During Anaesthesia of Children Undergoing Bone-Marrow Aspiration
- ClinicalTrials.gov ID
- NCT05636566
- Acronym / sponsor ID
- 0305414
- Conditions
- Invasive Cancer, Pediatric Cancer
- Keywords
- Dex-Profol, sevoflurane
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 25 Oct 2022 (actual)
- First posted
- 5 Dec 2022 (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.
No doubt that children facing surgical procedures are subjected to perioperative distressing, anxious and worrying periods. Several factors included; parental deprivation, anxiety, previously mismanaged experience and anticipating pain from the procedure itself weather diagnostic or curative. Anaesthetic goals should focus at alleviating these unfavorable events that may exacerbate the inevitable associated neurohormal stress response with its injurious effects on the course of the procedure. Moreover, it likely to extend beyond the surgical procedure predisposing these vulnerable group of patients to psychological trauma and chronic behavioral changes.
Bone marrow aspiration (BMA) is a frequent procedure that necessitate a meticulous anaesthetic plane that entails rapid non-traumatic induction together with adequate pain free maintenance and instant smooth recovery after a short time practice. Total intravenous anaesthesia (TIVA) had emerged as alternative anaesthetic technique to inhalational anaesthesia for conscious sedation in BMA cited by many authors.
Propofol a popular anaesthetic/ sedative with a rapid onset, short duration and smooth recovery of consciousness and psychomotor functions with no cumulation. However it is poorly analgesic, depresses respiration and there is a possibility of loss of muscle tone leading to airway obstruction .
Dexmedetomidine is a greatly active α2 adrenergic agonist with a valuable anaesthetic- analgesic saving effects. It augments sedation, hypnosis and preservation of muscle tone with negligible respiratory depression and hemodynamic derangements.
The purpose of the current study is to compare between effects of TIVA using propofol or dexmedetomedine versus sevoflurane for maintenance of anaesthesia in children undergoing bone marrow aspiration.
Detailed description
Background: although bone marrow aspiration in children is a familiar short duration procedure, nearly 65% of patients develop sever anxiety that may extend more beyond, up to chronic postoperative behavioral changes. Consequently, the objectives of any related anaesthetic technique is to afford smooth non-traumatic induction with safe maintenance and rapid recovery. The rational of the present study is to compare between TIVA using propofol or dexmedetomedine and sevoflurane for maintenance of anaesthesia in children scheduled for bone marrow aspiration.
Patients and methods: 60 child aged 3-12 years with ASA physical status I and II planned for elective bone marrow biopsy and aspiration were enrolled randomly into 3 groups 20 child each; group(S): received sevoflurane- oxygen for induction and sevoflurane with fentanyl infusion for maintenance of anaesthesia. Group (P): received propofol for induction followed by propofol-fentanyl infusions for maintenance of anaesthesia. Group (D): received dexmedetomedine infusion for induction followed by dexmedetomedine-fentanyl infusions for maintenance of anaesthesia. The primary endpoint was postoperative sedation score on arrival to the post anaesthetic care unit (PACU) after surgery. Secondary outcomes included procedure duration, hemodynamic variables, parents and surgeons satisfaction and incidences of any adverse events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Sixty patients were randomized and assigned into 3 groups (n=20) each, using sealed envelope technique: * Group (S): received sevoflurane- oxygen for induction and sevoflurane with fentanyl (Fentanyl, Janssen-Cilag, Germany) infusion for maintenance of anaesthesia. * Group (P): received propofol (Diprivan, Astra Zeneca, Wedel, Germany) for induction followed by propofol-fentanyl infusions for maintenance of anaesthesia. * Group (D): received dexmedetomedine (Precedex, Dexmedetomedine HCL inj.,Hospira, Inc.,Lacke Forest, USA) infusion for induction followed by dexmedetomedine-fentanyl infusions for maintenance of anaesthesia. All solutions were prepared by a team member not participating in data recording of the study.
| Arm | Type | Receives |
|---|---|---|
| Group (S) | Active comparator | Drug: Sevofluranesevoflurane inhalational anaesthesia for induction, then sevoflurane and fentanyl infusion for maintenance , |
| Group P | Active comparator | Drug: Propofol infusion for maintancepropofol infusion for induction afterward propofol and fentanyl infusions for maintenance of anaesthesia |
| Group D | Active comparator | Drug: Dexmedetomidinedexmedetomedine infusion for induction after that dexmedetomedine and fentanyl infusions for maintenance |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- patients aged 3-12 years.
- both sexes
- ASA physical status I and II
Key exclusion criteria (6 listed)
- Patients with identified allergy to the study medications
- with recognized lipid or carbohydrate deranged metabolism
- cardiac dysrhythmias
- congenital heart diseases
- cardiomyopathy
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 |
|---|---|---|
| Sevofluraneinhalational anaesthesia for maintenance | Drug | Group (S) |
| Propofol infusion for maintancepropofol infusion after induction for maintenance of anaesthesia | Drug | Group P |
| Dexmedetomidine0.5 mic /kg dexmedetomedine is injected after induction of anaesthesia | Drug | Group D |
Primary outcome
sedation score
Time frame: immediately postoperative
indicator for post operative alertness, . Sedation level: Agitated = 4, Awake= 3, Drowsy= 2, Asleep= 1. A sedation score of 3 \& above was considered as unsatisfactory while 1 \& 2 is considered to be satisfactory.
1 secondary outcome
time for spontenous eye opening
Time frame: immediately postoperative
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 5 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Invasive Cancer
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 2
BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer
Breast Cancer Invasive, Early-stage Breast Cancer
RecruitingObservational study
Negative/Low Hormone Receptor And/or HER2 POsitive Lobular Invasive Breast Carcinoma - A Real-World International Cohort Study
Lobular Breast Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer
Non-muscle Invasive Bladder Cancer
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 2/3 study testing Sevoflurane, Propofol infusion for maintance and Dexmedetomidine in people with Invasive Cancer and Pediatric Cancer, run by Alexandria 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 5 Dec 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 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
sedation score (time frame: immediately postoperative). 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 5 Dec 2022.