Fayoum University Hospital
Al Fayyum, Faiyum Governorate, 63514, Egypt
Location status: Recruiting
NCT Number: NCT06867302
The main objective of study is to compare dexmedetomidine single bolus dose before extubation with continuous infusion as regards their efficacy in mitigating the incidence of emergence agitation in obese adults undergoing nasal surgery.
Interested in participating?
Request Info18 year–50 year
All sexes
Interventional
Not applicable
Al Fayyum, Faiyum Governorate, 63514, Egypt
Location status: Recruiting
Agitation during emergence from general anesthesia is a potentially serious phenomenon that has not been studied in adults as often as in pediatric population. When agitation, serious self-injury, or violence towards the medical team occur, with the risk of aspiration, bleeding, hypoxia, arrhythmias, or simply pulling the endotracheal tubes, removal of drains or catheters. Moreover, agitated patients are not only at risk of developing complications but also, they are labor intensive as they require more medical attention, rescue drugs, and more attending staff till agitation attack safely subside. Recognized risk factors to develop emergence agitation (EA) in adults include ear, nose, and throat surgery, obesity, sevoflurane anesthesia, endotracheal tube, and history of psychological illness. In adults, adjuvants have been co-administered with general anesthesia in order to negate or reduce the incidence of EA especially in patients with identified risk factors.
dexmedetomidine is a highly selective α2 sympatholytic, has been proposed as an attractive candidate for the prophylaxis of EA. By interacting with α2 receptors in locus coeruleus of the pons, Dex exerts its unique anxiolytic, sedative and sympathetic antagonistic action with no respiratory depression. Moreover, it has pain-modulating effect due to interaction with α2 receptor sites in the dorsal horn and supra-spinal regions.
Nevertheless, there have been conflicting data about Dex optimal dose and time of administration when used as prophylaxis against EA. Indeed, different dosing protocols are associated with over sedation, prolonged extubation time, and delayed post-anaesthesia care unit time.
No premedication. Basic general anesthesia monitoring included electrocardiogram, pulse oximetry, non-invasive arterial pressure, and capnography, were recorded every 5 min. Preoxygenation with 100% oxygen for 5 min was performed before fentanyl 1 μg/kg and propofol 1.5-2 mg/ kg, were administered as induction agents. Intubation with facilitated with atracurium besylate 0.5 mg/ kg. The size of endotracheal tubes was 6.5-7.5 mm, for females and males, respectively. Mechanical ventilation was set on 6 ml/kg tidal volume, and respiratory rate was adjusted to keep end-tidal CO2 between 35 and 40 mmHg, in 50% O2/air. All patients at induction were given dexamethasone 4 mg i.v., ondansetron, 4 mg i.v to prevent post-operative nausea and vomiting, plus Ringers lactate solution 6 mg/ kg drip for basic volume maintenance. Blood loss was compensated for with Ringers lactate, intraoperatively. Maintenance of anesthesia was carried out with Isoflurane, regulated at 2-3%, Titrated incremental doses of atropine 0.5 mg, esmolol 10 mg, and ephedrine 6 mg were given i.v., when HR ≤ 45, HR ≥ 120 and MAP ≤ 60, in the mentioned order. ketorolac 30 mg was given I.M., at the time of nasal packing.
When surgery was finished, gentle suction was attempted, non-depolarizing muscle relaxant reverse with atropine, 0.5 mg and neostigmine 0.02 mg/kg was given. Next, isoflurane was turned off and respiration was then converted back to manual ventilation with 100% oxygen at 7 L/min. The patients were not disturbed, except by continual verbal requests to open their eyes. All other stimuli were prevented. Extubation was done when patients were able to breathe spontaneously and interact with verbal demands. When patients were awake, calm, and sedated, they were transferred to the PACU. Patients were discharged from the PACU when their Aldrete score was ≥ 9.
Statistical analysis:
Statistical analysis will be conducted using IBM SPSS Statistics 22 (IBM Corporation, USA). The normal distribution of data will be assessed by the Kolmogorov-Smirnov and Shapiro-Wilk tests. Mean and standard deviation will be used as descriptive statistics for normally distributed numerical variables, while median and interquartile range (25th to 75th percentiles) will be used as descriptive statistics for non-normally distributed numerical variables. In addition, Chi-square test or fisher exact test will be employed to test the significance between categorical variables as appropriate. Independent t test will be employed for numerical data that exhibited normal distribution, whereas the Mann-Whitney test will be used for numerical data that did not adhere to normal distribution. A significance level of p < 0.05 will be deemed to be statistically significant.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
An infusion given all through intraoperative time
Other names: Dexmedetomidine infusion
Single dose given 15 minutes before end of surgery
Other names: Dexmedetomidine bolus
Time frame: 5 minutes after operation
RASS is a 10-point scoring system used to assess patient's level of agitation and sedation: 4 levels for agitation, 1 level for normal (alert and calm), and 5 levels of sedation
Time frame: Every 15 minutes along operation
Beats / minute
Time frame: Every 15 minutes along operation
mmHg
Time frame: 5 minutes before first analgesic request
in minutes in minutes
Time frame: 3 minutes after removal of endotracheal tube
time interval between shutting off anesthetics to extubation (in minutes)
Time frame: 5 minutes after discharge from recovery unit
time interval from admission to PACU till patient scored ≥ 9 on Aldrete scale (ready to discharge)
Time frame: 2 minutes after occurence of emergence agitation
Yes or no
Time frame: Every 10 min in postanesthesia care unit
10 point scale where zero meaning "no pain" and 10 meaning "the worst pain imaginable"
Time frame: 24 hours postoperative
in milligram
Time frame: 2 hours intraoperatively
endoscopically using the six-point score (0-5 Scale) where 0 - No bleeding, 1 - Slight bleeding, no suctioning needed, 2 - Slight bleeding, occasional suctioning needed, 3 - Moderate bleeding, frequent suctioning needed, visibility maintained, 4 - Heavy bleeding, constant suctioning needed, visibility impaired, 5 - Severe bleeding, uncontrolled, surgery impossible
Time frame: 2 hours intraoperatively
Yes or no
Time frame: 2 hours intraoperatively
Yes or no when mean arterial blood pressure below 60 mmHg
Time frame: 24 hours postoperative
Yes or no
Time frame: 24 hours postoperative
Yes or no
Time frame: 5 minutes before entering operation department
in years
Time frame: 5 minutes before entering operation department
Male of female
Time frame: 5 minutes before entering operation department
In kilogram
Time frame: 5 minutes before entering operation department
In centimeter
Time frame: 5 minutes after end of surgery
In minutes
Contact information is provided by the study sponsor or research team.
Mohamed A Shawky, MD
CONTACT
0 109 525 4547 ext. +2
Yasser S Mostafa, MD
CONTACT
01010509735 ext. +2
Fayoum University Hospital
Other
Effectiveness of Single Bolus Versus Continuous Infusion of Dexmedetomidine in Mitigating Agitation in Adults Undergoing Nasal Surgery: a Prospective Randomized Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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