Dexmedetomidine and Agitation After Nasal Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorFayoum University Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
American Society of Anesthesiologist (ASA) Ⅰ or II
Adults with body mass index (BMI) < 30 Kg/m
Underwent elective nasal surgery.
Disqualifiers
Significant comorbidity like hepatic, renal, or cardiac disease
Auditory impairment
Cognitive dysfunction
Substance abuse
Trial design
Design model
Parallel
Treatments tested in this trial
Dexmedetomidine in 0.9 % NaCl 1,000 Mcg/250 mL (4 Mcg/mL) INTRAVEN INFUSION BOTTLE (ML)
DrugAn infusion given all through intraoperative time
Dexmedetomidine Injection [Precedex]
DrugSingle dose given 15 minutes before end of surgery
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Bolus groupExperimental treatment 1 intervention
Group B: Infusion groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Degree of emergence agitation by Richmond Agitation Sedation Scale (RASS)
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
5 minutes after operationSecondary outcomes
1
Intraoperative heart rate
Beats / minute
Time frame
Every 15 minutes along operation2
Intraoperative mean arterial blood pressure
mmHg
Time frame
Every 15 minutes along operation3
Time of first rescue analgesic
in minutes in minutes
Time frame
5 minutes before first analgesic request4
Extubation time
time interval between shutting off anesthetics to extubation (in minutes)
Time frame
3 minutes after removal of endotracheal tubeOther outcomes
1
Age
in years
Time frame
5 minutes before entering operation department2
Sex
Male of female
Time frame
5 minutes before entering operation department3
Weight
In kilogram
Time frame
5 minutes before entering operation department4
Height
In centimeter
Time frame
5 minutes before entering operation departmentSponsors and contacts
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Source ClinicalTrials.gov