Condition or disease | Intervention/treatment | Phase |
---|---|---|
Agitation, Emergence | Drug: "Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline" | Early Phase 1 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Masking Description: | patient and outcomes assessor |
Primary Purpose: | Prevention |
Official Title: | Single Bolus Dose of Ketodex Versus Ketofol For Prevention Of Emergence Agitation In Adults Undergoing Nasal Surgeries |
Actual Study Start Date : | July 3, 2019 |
Actual Primary Completion Date : | November 20, 2019 |
Actual Study Completion Date : | November 23, 2019 |
Arm | Intervention/treatment |
---|---|
Active Comparator: ketodex
ketamine dexmedetomidine mixture
|
Drug: "Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline"
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.
Other Names:
|
Active Comparator: ketofol
ketamine propofol mixture
|
Drug: "Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline"
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.
Other Names:
|
Placebo Comparator: placebo
normal saline
|
Drug: "Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline"
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.
Other Names:
|
Ages Eligible for Study: | 21 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Patient acceptance.
Exclusion Criteria:
Egypt | |
Faculty of Medicine | |
Zagazig, Elsharkia, Egypt, 022/055 |
Principal Investigator: | Olfat Amin, M.D | Faculty of medicine, Zagazig university |
Tracking Information | |||||
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First Submitted Date ICMJE | July 4, 2019 | ||||
First Posted Date ICMJE | July 12, 2019 | ||||
Last Update Posted Date | November 27, 2019 | ||||
Actual Study Start Date ICMJE | July 3, 2019 | ||||
Actual Primary Completion Date | November 20, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Single Bolus Dose of Ketodex Versus Ketofol For Prevention Of Emergence Agitation In Adults Undergoing Nasal Surgeries | ||||
Official Title ICMJE | Single Bolus Dose of Ketodex Versus Ketofol For Prevention Of Emergence Agitation In Adults Undergoing Nasal Surgeries | ||||
Brief Summary |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Early Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Masking Description: patient and outcomes assessor Primary Purpose: Prevention
|
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Condition ICMJE | Agitation, Emergence | ||||
Intervention ICMJE | Drug: "Ketamine" and "dexmedetomidine" and "propofol" and "0.9%saline"
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.
Other Names:
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
150 | ||||
Original Actual Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | November 23, 2019 | ||||
Actual Primary Completion Date | November 20, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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Sex/Gender ICMJE |
|
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Ages ICMJE | 21 Years to 60 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Egypt | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04018157 | ||||
Other Study ID Numbers ICMJE | 5452 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | olfat abd elmoniem ibrahem, Zagazig University | ||||
Study Sponsor ICMJE | Zagazig University | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Zagazig University | ||||
Verification Date | November 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |