DexmedetomidineNCT05786833
Dexmedetomidine vs Ketofol on Delirium in Children Undergoing Congenital Inguinal Hernia Repair
A study testing Dexmedetomedine, Ketofol and isotonic saline 0.9% in people with Dexmedetomidine and Ketofol, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the effect of dexmedetomidine versus ketofol on the incidence of the emergence delirium in children undergoing congenital inguinal hernia repair. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Dexmedetomidine, Ketofol, Delirium
- What is being tested?
- Dexmedetomedine, Ketofol and isotonic saline 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2023to 20 Oct 2023
- 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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 60 children aged from 2 to 5 years
- presented with congenital inguinal hernia
- the American Society of Anaesthesiologists classification ASA I-II.
Who cannot join
- Past medical history of mental illness or neurological illness.
- Renal or hepatic diseases.
- Severe hearing or visual impairment which may interfere with communication and physical decline.
- Congenital heart disease.
- History of allergy to any of the study drugs.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Nada Maged Shaheen
Tanta, El-Gharbia, 31527
Nada M Shaheen, Master, +201006151953 ext. 139, nada169730_pg@med.tanta.edu.eg
About this study
Official title: Dexmedetomidine Infusion Versus Ketofol Infusion on The Incidence of Emergence Delirium in Children Undergoing Congenital Inguinal Hernia Repair: A Prospective Randomized Trial.
The aim of this study is to compare the effect of dexmedetomidine versus ketofol on the incidence of the emergence delirium in children undergoing congenital inguinal hernia repair.
Read the detailed description
Emergence delirium (ED) is a disturbance in a child's awareness or attention to his/her environment with disorientation and perceptual alterations including hypersensitivity to stimuli and hyperactive motor behaviour in the immediate post anesthesia period.
Propofol is a non-opioid, non-barbiturate, sedative-hypnotic agent with rapid onset and short duration of action [12]. Ketamine is a phencyclidine derivative classified as a dissociative sedative that provides analgesia and amnesia.
Combination of ketamine with propofol reduces the sedative dose of propofol. The complementary effects of this combination are supposed to produce lower toxicity compared to each drug alone through decreasing required doses. Ketofol; mixed ketamine and propofol has been shown to be effective in emergency room for procedural sedation and for induction for rapid sequence intubation [13,14]. This combination is also effective to prevent ED in pediatric patients undergoing simple surgical procedural in addition to the advantage of better hemodynamic stability.
Dexmedetomidine is a highly selective, alpha2-adrenergic receptor agonist that has been widely used for adult anesthesia and as a sedative in intensive care units. Dexmedetomidine is safe in children due to its hypnotic, analgesic, sedative, and anxiolytic effects. it has been shown to improve intraoperative hemodynamic stability, minimize responses to stimuli, and reduce the need for other anesthetic agents.
- Conditions
- Dexmedetomidine, Ketofol, Delirium, Hernia
- Being tested
- Dexmedetomedine, Ketofol, isotonic saline 0.9%
- Medical subject headings
- Delirium, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomedineDrug
Patients will receive intraoperative dexmedetomedine intravenous infusion at a dose of 0.2µg/kg/hour.
KetofolDrug
Patients will receive intraoperative ketofol (1:10 ratio of ketamine-propofol mixture) intravenous infusion with %90 of Mcfarlan dose regiment. McFarlan dose regiments include 15 mg/kg/h infusion during 15 minutes, 13 mg/kg/h infusion during second 15 minutes, 11 mg/kg/h infusion from half to 1 and 10 mg/kg/h from 1 to 2 hours.
isotonic saline 0.9%Drug
Patients will receive intravenous infusion of equivalent volume of isotonic saline 0.9%.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine Group | Active comparator | Not described Receives: Drug: Dexmedetomedine |
| Ketofol Group | Active comparator | Not described Receives: Drug: Ketofol |
| Control Group | Placebo comparator | Not described Receives: Drug: isotonic saline 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative emergence delirium
Assessment of delirium using Pediatric Anesthesia Emergence Delirium (PAED) will be performed on arrival at the Post Anesthesia Care Unit (PACU)
Measured: 5 -15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start20 Mar 2023
- Primary completion20 Oct 2023 (estimated)
- Study completion20 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies of the same condition, open and under way.
- More trials run by Tanta 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Maged Shaheen, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786833
- Sponsor's protocol ID
- 36264MS43/1/23
- Status last verified
- Mar 2023
- First submitted
- 10 Mar 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon reasonable request from the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Infusion Versus Ketofol Infusion on The Incidence of Emergence Delirium in Children Undergoing Congenital Inguinal Hernia Repair: A Prospective Randomized Trial.
- ClinicalTrials.gov ID
- NCT05786833
- Acronym / sponsor ID
- 36264MS43/1/23
- Conditions
- Dexmedetomidine, Ketofol, Delirium, Hernia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 20 Oct 2023 (estimated)
- Study completion
- 20 Oct 2023 (estimated)
- First posted
- 28 Mar 2023 (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 study is to compare the effect of dexmedetomidine versus ketofol on the incidence of the emergence delirium in children undergoing congenital inguinal hernia repair.
Detailed description
Emergence delirium (ED) is a disturbance in a child's awareness or attention to his/her environment with disorientation and perceptual alterations including hypersensitivity to stimuli and hyperactive motor behaviour in the immediate post anesthesia period.
Propofol is a non-opioid, non-barbiturate, sedative-hypnotic agent with rapid onset and short duration of action [12]. Ketamine is a phencyclidine derivative classified as a dissociative sedative that provides analgesia and amnesia.
Combination of ketamine with propofol reduces the sedative dose of propofol. The complementary effects of this combination are supposed to produce lower toxicity compared to each drug alone through decreasing required doses. Ketofol; mixed ketamine and propofol has been shown to be effective in emergency room for procedural sedation and for induction for rapid sequence intubation [13,14]. This combination is also effective to prevent ED in pediatric patients undergoing simple surgical procedural in addition to the advantage of better hemodynamic stability.
Dexmedetomidine is a highly selective, alpha2-adrenergic receptor agonist that has been widely used for adult anesthesia and as a sedative in intensive care units. Dexmedetomidine is safe in children due to its hypnotic, analgesic, sedative, and anxiolytic effects. it has been shown to improve intraoperative hemodynamic stability, minimize responses to stimuli, and reduce the need for other anesthetic agents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine Group | Active comparator | Drug: Dexmedetomedine |
| Ketofol Group | Active comparator | Drug: Ketofol |
| Control Group | Placebo comparator | Drug: isotonic saline 0.9% |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 60 children aged from 2 to 5 years
- presented with congenital inguinal hernia
- the American Society of Anaesthesiologists classification ASA I-II.
Key exclusion criteria (5 listed)
- Past medical history of mental illness or neurological illness.
- Renal or hepatic diseases.
- Severe hearing or visual impairment which may interfere with communication and physical decline.
- Congenital heart disease.
- History of allergy to any of the study drugs.
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 |
|---|---|---|
| DexmedetomedinePatients will receive intraoperative dexmedetomedine intravenous infusion at a dose of 0.2µg/kg/hour. | Drug | Dexmedetomidine Group |
| KetofolPatients will receive intraoperative ketofol (1:10 ratio of ketamine-propofol mixture) intravenous infusion with %90 of Mcfarlan dose regiment. McFarlan dose regiments include 15 mg/kg/h infusion during 15 minutes, 13 mg/kg/h infusion during second 15 minutes, 11 mg/kg/h infusion from half to 1 and 10 mg/kg/h from 1 to 2 hours. | Drug | Ketofol Group |
| isotonic saline 0.9%Patients will receive intravenous infusion of equivalent volume of isotonic saline 0.9%. | Drug | Control Group |
Primary outcome
Incidence of postoperative emergence delirium
Time frame: 5 -15 minutes
Assessment of delirium using Pediatric Anesthesia Emergence Delirium (PAED) will be performed on arrival at the Post Anesthesia Care Unit (PACU)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Individual participant dataSharing planned: Yes. The data will be available upon reasonable request from the principal investigator
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomedine, Ketofol and isotonic saline 0.9% in people with Dexmedetomidine and Ketofol, run by Tanta 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 5 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 5 Apr 2023. 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.
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 Nada M Shaheen, Master (+201006151953 ext. 139, nada169730_pg@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative emergence delirium (time frame: 5 -15 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 5 Apr 2023.