Agitation, EmergenceEarly Phase 1NCT04018157
Single Bolus Dose of Ketodex Versus Ketofol For Prevention Of Emergence Agitation In Adults Undergoing Nasal Surgeries
A Early Phase 1 study testing "Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline" in people with Agitation, Emergence, run by Zagazig University at 1 site in Egypt.
Trial summary
emergence agitation is seen in around 68% after nasal surgeries. Agitated patients needs more staff and nurses to control their abnormal movement which leads to self extubation , removal of catheters and bruises in the extremities. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Agitation, Emergence
- What is being tested?
- "Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline"
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jul 2019to 23 Nov 2019
- Phase
- Early Phase 1
- 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient acceptance.
- Both gender.
- Age (21-60) years old.
- patient with Body Mass Index (BMI) (25-35kg/m²).
- American Society of Anesthesiologist (ASA) I / II
- Adult patient scheduled to elective nasal surgeries
Who cannot join
- - Patient with difficult airway (mallampati III,IV).
- Altered mental status (psychiatric and anxiety disorder).
- Post traumatic stress disorders.
- History of allergy to study drugs.
- Patient on sedative or hypnotic medication.
- Patients with chronic pain or on painkiller.
Show all 10Show fewer
- Patients with severe hepatic or kidney impairment.
- Patients having a history of thyrotoxicosis, hypertension, cardiac , chest or neurological disease.
- Patient receiving B agonist.
- Pregnant or breast feeding female.
Trial locations and contacts
1 site in 1 country.
About this study
- emergence agitation is seen in around 68% after nasal surgeries. Agitated patients needs more staff and nurses to control their abnormal movement which leads to self extubation , removal of catheters and bruises in the extremities.
- Dexmedetomidine, ketamine, propofol intravenous infusion and other agents was used to prevent EA . Recently, ketodex is found to reduce the incidence and severity of EA .
- We aim to compare single bolus dose of Ketodex Versus Ketofol For Prevention Of emergence Agitation in adults undergoing nasal surgeries.
Read the detailed description
The incidence of emergence agitation (EA) after nasal surgeries is relatively high , it is reported to be 68% (1).The precise mechanism is not known. Awake extubation after nasal surgeries is preferred as the airway may be contaminated by blood , and the nasal airway may be blocked by surgical packs that causes sense of suffocation. Awake extubation and nasal pack is a trigger to emergence agitation(2).
emergence agitation (EA) is harmful to the patient and the staff, it Characterized by disorientation, confusion, abnormal violent movement that may result in serious complication and morbidity(3). It develops early with the recovery from general anesthesia(4). Although agitation is more observed in pediatrics but its incidence in adults reach up to 21.4% (5).
Different medication agents such as anesthetic drugs, benzodiazepine and α2 agonist was proved to attenuate the EA with different efficiencies (6).
Dexmedetomidine is a selective α2 adrenoceptor agonist. It has sedative, hypnotic, anxiolytic, analgesic and sympatholytic properties. It was proved to reduce the EA in children(7). However there was few data about its effect in reducing the agitation in adult after general anesthesia(8).
Propofol is short acting hypnotic and sedative agent. It is used for induction and maintenance of anesthesia(9). Previous studies proved that propofol was effective in preventing EA (10,11) and depends on the time of administration(12).
Ketamine is N-methyl- D-asparate receptor antagonist, it has anesthetic, sedative and analgesic effect(13).
Ketofol is a combination of low dose ketamine with propofol , it has been used for sedation and analgesia. The effect of this combination was supposed to produce less toxicity compared to each drug alone by decreasing the required doses(14).
Ketodex is combined low dose of ketamine and dexmedetomidine, it was used for sedation , this combination decrease some of the pitfalls occurring when use dexmedetomidine as a sole agent(15).
Most EA studies was done in pediatric. To our knowledge there was no previous studies report the effect of bolus dose of ketodex versus ketofol on the incidence and prevention of EA after nasal surgeries in adults. This study aimed to compare single bolus dose of Ketodex Versus Ketofol For Prevention Of Emergence Agitation In adults Undergoing nasal surgeries.
- Conditions
- Agitation, Emergence
- Being tested
- "Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline"
- Keywords
- ketodex, ketofol , agitation , nasal surgery
- Medical subject headings
- Emergence Delirium, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline"Drug
Also called ketalar, precedex, diprivan
patients will receive single intravenous bolus of combination from ketamine 0.5mg/kg and dexmedetomidine 1ug/kg in one syringe diluted in 10 ml 0.9% saline.
| Study group | Role | What they receive |
|---|---|---|
| ketodex | Active comparator | ketamine dexmedetomidine mixture Receives: Drug: "Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline" |
| ketofol | Active comparator | ketamine propofol mixture Receives: Drug: "Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline" |
| placebo | Placebo comparator | normal saline Receives: Drug: "Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline" |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of emergence agitation.
The incidence of emergence agitation.
Measured: up to 60 minutes after extubation
The level of emergence agitation.
The level of emergence agitation measured by . Richmond Agitation-Sedation scale (RASS) is ten scales; five for sedation level ,one for alertness and calmness, and four for agitation level as follow: -5 unarousable , -4 deep sedation , -3 moderate sedation , -2 light sedation , -1 drowsy ; 0 alert and calm,+1 restless , +2 agitated , +3 very agitated and +4 combative. Patients with score ≥ 2 considered having agitation.
Measured: up to 60 minutes after extubation
Secondary outcomes (5)
The Emergence time
The time from discontinuation of isoflurane to first response to verbal command.
Measured: up to 20 minutes after discontinuation of isoflurane
The extubation time
time from discontinuation of isoflurane to extubation.
Measured: up to 20 minutes after discontinuation of isoflurane
The time of discharge
The time from arrival to postanesthesia care unite (PACU) to discharge to the ward according to modified aldert score
Measured: up to 40 minutes after extubation
Postoperative Pain is evaluated using Numerical rating Scale (NRS)
(NRS) A commonly used scale is a 10-cm line labeled with "worst pain imaginable" on the right border and "no pain" on the left border.
Measured: up to 40 minutes after extubation
"Number of Participants with vomiting or hypotension or bradycardia"
vomiting , hypotension, bradycardia Vomiting
Measured: all over 40 minutes post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start3 Jul 2019
- Primary completion20 Nov 2019
- Study completion23 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Agitation, EmergenceStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, olfat abd elmoniem ibrahem, Zagazig University
- Investigators
- Olfat Amin, M.D, Principal investigator, Faculty of medicine, Zagazig university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018157
- Sponsor's protocol ID
- 5452
- Status last verified
- Nov 2019
- First submitted
- 4 Jul 2019
- Last updated
- 27 Nov 2019
- 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 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Bolus Dose of Ketodex Versus Ketofol For Prevention Of Emergence Agitation In Adults Undergoing Nasal Surgeries
- ClinicalTrials.gov ID
- NCT04018157
- Acronym / sponsor ID
- 5452
- Conditions
- Agitation, Emergence
- Keywords
- ketodex, ketofol , agitation , nasal surgery
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 23 Nov 2019 (actual)
- First posted
- 12 Jul 2019 (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.
- emergence agitation is seen in around 68% after nasal surgeries. Agitated patients needs more staff and nurses to control their abnormal movement which leads to self extubation , removal of catheters and bruises in the extremities.
- Dexmedetomidine, ketamine, propofol intravenous infusion and other agents was used to prevent EA . Recently, ketodex is found to reduce the incidence and severity of EA .
- We aim to compare single bolus dose of Ketodex Versus Ketofol For Prevention Of emergence Agitation in adults undergoing nasal surgeries.
Detailed description
The incidence of emergence agitation (EA) after nasal surgeries is relatively high , it is reported to be 68% (1).The precise mechanism is not known. Awake extubation after nasal surgeries is preferred as the airway may be contaminated by blood , and the nasal airway may be blocked by surgical packs that causes sense of suffocation. Awake extubation and nasal pack is a trigger to emergence agitation(2).
emergence agitation (EA) is harmful to the patient and the staff, it Characterized by disorientation, confusion, abnormal violent movement that may result in serious complication and morbidity(3). It develops early with the recovery from general anesthesia(4). Although agitation is more observed in pediatrics but its incidence in adults reach up to 21.4% (5).
Different medication agents such as anesthetic drugs, benzodiazepine and α2 agonist was proved to attenuate the EA with different efficiencies (6).
Dexmedetomidine is a selective α2 adrenoceptor agonist. It has sedative, hypnotic, anxiolytic, analgesic and sympatholytic properties. It was proved to reduce the EA in children(7). However there was few data about its effect in reducing the agitation in adult after general anesthesia(8).
Propofol is short acting hypnotic and sedative agent. It is used for induction and maintenance of anesthesia(9). Previous studies proved that propofol was effective in preventing EA (10,11) and depends on the time of administration(12).
Ketamine is N-methyl- D-asparate receptor antagonist, it has anesthetic, sedative and analgesic effect(13).
Ketofol is a combination of low dose ketamine with propofol , it has been used for sedation and analgesia. The effect of this combination was supposed to produce less toxicity compared to each drug alone by decreasing the required doses(14).
Ketodex is combined low dose of ketamine and dexmedetomidine, it was used for sedation , this combination decrease some of the pitfalls occurring when use dexmedetomidine as a sole agent(15).
Most EA studies was done in pediatric. To our knowledge there was no previous studies report the effect of bolus dose of ketodex versus ketofol on the incidence and prevention of EA after nasal surgeries in adults. This study aimed to compare single bolus dose of Ketodex Versus Ketofol For Prevention Of Emergence Agitation In adults Undergoing nasal surgeries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ketodex | Active comparator | Drug: "Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline"ketamine dexmedetomidine mixture |
| ketofol | Active comparator | Drug: "Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline"ketamine propofol mixture |
| placebo | Placebo comparator | Drug: "Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline"normal saline |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient acceptance.
Key exclusion criteria (10 listed)
- - Patient with difficult airway (mallampati III,IV).
- Altered mental status (psychiatric and anxiety disorder).
- Post traumatic stress disorders.
- History of allergy to study drugs.
- Patient on sedative or hypnotic medication.
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 |
|---|---|---|
| "Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline"Also: ketalar, precedex, diprivanpatients will receive single intravenous bolus of combination from ketamine 0.5mg/kg and dexmedetomidine 1ug/kg in one syringe diluted in 10 ml 0.9% saline. | Drug | ketodex, ketofol, placebo |
Primary outcome
The incidence of emergence agitation.
Time frame: up to 60 minutes after extubation
The incidence of emergence agitation.
The level of emergence agitation.
Time frame: up to 60 minutes after extubation
The level of emergence agitation measured by . Richmond Agitation-Sedation scale (RASS) is ten scales; five for sedation level ,one for alertness and calmness, and four for agitation level as follow: -5 unarousable , -4 deep sedation , -3 moderate sedation , -2 light sedation , -1 drowsy ; 0 alert and calm,+1 restless , +2 agitated , +3 very agitated and +4 combative. Patients with score ≥ 2 considered having agitation.
5 secondary outcomes
The Emergence time
Time frame: up to 20 minutes after discontinuation of isoflurane
The extubation time
Time frame: up to 20 minutes after discontinuation of isoflurane
The time of discharge
Time frame: up to 40 minutes after extubation
Postoperative Pain is evaluated using Numerical rating Scale (NRS)
Time frame: up to 40 minutes after extubation
"Number of Participants with vomiting or hypotension or bradycardia"
Time frame: all over 40 minutes post-operative
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 27 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Olfat Amin, M.D principal investigator
Faculty of medicine, Zagazig university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing "Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline" in people with Agitation, Emergence, run by Zagazig 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 6 inclusion and 10 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 27 Nov 2019. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
The incidence of emergence agitation. (time frame: up to 60 minutes after extubation). 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 27 Nov 2019.