Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04659642 |
| Other study ID # |
dexmedetomidine in anesthesia |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Early Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
November 30, 2020 |
| Est. completion date |
March 20, 2021 |
Study information
| Verified date |
March 2021 |
| Source |
National Cancer Institute, Egypt |
| Contact |
asmaa abdulwahhab, M.sc |
| Phone |
1212959293 |
| Email |
asmafhmy[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of this blind comparative study was to compare the effects of dexmedetomidine,
fentanyl and their combination on airway reflexes and hemodynamic responses to tracheal
extubation in Adult chronic male smoking patients scheduled for abdominal surgeries (of
average 2-3 hours duration).
Description:
Tracheal extubation is associated with acute, transient, significant and undesirable
hemodynamic and airway responses that may persist into the recovery period. Respiratory
complications after tracheal extubation are three times more common than complications
occurring during tracheal intubation and induction of anesthesia (4.6% vs 12.6%) .
The peak changes are noticed about 1 minute following extubation and may continue until 10
minutes . The reflexes ranges from coughing, bucking, agitation to bronchospasm,
laryngospasm, laryngeal oedema, negative pressure pulmonary oedema, tachycardia,
hypertension, arrhythmias, left ventricular failure, myocardial ischemia, increased bleeding,
raised intracranial and intraocular pressure and cerebrovascular hemorrhage in susceptible
individuals. Although most patients can tolerate these transient effects without any
significant consequences, but this could be detrimental in patients operated for cardiac,
neuro or ophthalmic lesions especially if hypertensive or diabetic. However, Tracheal
extubation in smokers will increase difficulty.
Smoking is a risk factor for intraoperative and postoperative complications mainly related to
pulmonary and cardiovascular systems. Long-term exposure to cigarettes causes an increased
response to the mechanical stimulation caused by extubation.
Smoking affects oxygen transport and delivery , Irritants in smoke increase mucous secretion
which becomes hyper viscous with impaired tracheobronchial clearance . Smoking increases
sympathetic activation due to increased release of catecholamines and the delay in nicotine
clearance from the neuroeffector junction leading to higher blood pressure, tachycardia, and
increase peripheral vascular resistance .
For a smooth extubation, there should be no straining, movement, coughing, breath holding or
laryngospasm. Extubation at light levels of anesthesia or sedation can stimulate reflex
responses via tracheal and laryngeal irritation . A variety of drugs such as esmolol,
alfentanil, diltiazem, verapamil, fentanyl, and lidocaine have been used to control
hemodynamic changes and upper airway tract events, but they all have limitations and side
effects.
Alpha2 agonists decrease the sympathetic outflow and noradrenergic activity, thereby
counteracting hemodynamic fluctuations occurring at the time of extubation due to increased
sympathetic stimulation. Dexmedetomidine, an α2-adrenoreceptor agonist with a distribution
half-life of approximately 6 minutes has been successfully used for attenuating the stress
response to laryngoscopy .
Single dose of dexmedetomidine before extubation proved to attenuate both airway and
hemodynamic reflexes during emergence from anesthesia providing smooth extubation.
The addition of a single dose of dexmedetomidine to a low-dose infusion of remifentanil
during emergence from sevoflurane-remifentanil anesthesia was effective in attenuating cough
without further respiratory depression after thyroid surgery.
Administered 10 minutes before induction in chronic male smokers, dexmedetomidine was found
to suppress increased heart rate and rate-pressure product at 1 and 3 minutes after
intubation and, therefore, decrease the need for myocardial oxygen more than fentanyl.
Dexmedetomidine produces sedation while sparing responsiveness to CO2, and thus, it has less
effect on respiratory depression. Consequently, it has found utility and regulatory approval
for use in bronchoscopic examinations and for weaning intensive care unit patients from
mechanical ventilation. In addition, dexmedetomidine has been shown to reduce emergence
agitation in children and adults after general anesthesia.
Fentanyl, a synthetic opioid, has been reported to reduce the prevalence of coughing during
and after extubation and to suppress the sneezing reflex after abdominal hysterectomy and
periocular injections . Fentanyl has also been reported to attenuate the cardiovascular
responses to tracheal extubation in elective gynecologic surgery.
The subjects were Adult chronic male smokers, thus representing the population in which
secondary response to laryngoscopy and intubation is most common.
The study participants will be divided by mean of randomized complete block design into 3
comparable groups.
Group (A) : (n= 22) will receive Dexmedetomidine 1ug/kg body weight IV diluted to 100ml
normal saline (NS) over 15 minutes.
Group (B) : (n=22) will receive Fentanyl 1 ug/kg body weight IV diluted to 100 ml normal
saline (NS) over 15 minutes.
Group (C): (n=22) will receive both Dexmedetomidine 1ug/kg body weight mixed with fentanyl
1ug/kg in 100 ml normal saline (NS) over 15 minutes Pre-anesthetic checkup was conducted and
a detailed history and complete physical examination recorded. Routine investigations like
complete blood picture, blood grouping/typing, blood urea and serum creatinine were done.
Patients fulfilling inclusion criteria will be informed about the procedure and its possible
complications. Finally, written consent will be taken.
Routine anesthetic technique was used using propofol 2mg/kg, fentanyl 1.5 ug/kg, atracurium
0.5 mg /kg, oxygen and sevoflurane. Standard monitoring with electrocardiography (EKG), pulse
oximetry (SpO2), noninvasive BP and End tidal Co2 was done.
About 15 minutes before the estimated time of end of surgery (or at the beginning of closure
of skin incision,), inhalation agent (sevoflurane) was cut off and patients in each group
received the specified solution intravenously over 15 minutes.
Patients in group A received dexmedetomidine 1 mcg/kg intravenous (IV) in 100 ml normal
saline (NS) over 15 minutes ,patients in group B, received Fentanyl 1 mcg/kg (IV) in100 ml NS
over 15 minutes, while patients in group C received both Dexmedetomidine 1ug/kg mixed with
fentanyl 1ug/kg in 100 ml normal saline (NS) over 15 minutes.
When patients' spontaneous respirations were considered sufficient and patients were able to
obey simple commands residual neuromuscular block was antagonized with neostigmine 0.05 mg/kg
and atropine 0.02 mg/kg. Oropharyngeal secretions were aspirated before extubation. The
endotracheal tube was removed after spontaneous ventilation had returned.
The anesthesiologist performing the extubation was blinded to the study drugs. HR, systolic
BP and diastolic BP and oxygen saturation were recorded at the start of bolus drug injection
and thereafter at 1, 3, 5, 10 and 15 minutes., Also at the time of extubation and thereafter
at 1, 3 and 5 minutes after extubation followed by every 5 minutes for 30 minutes. Duration
of anesthesia and surgery are noted.
Data will be analyzed using IBM SPSS advanced statistics (Statistical Package for Social
Sciences), version 22 (SPSS Inc., Chicago, IL). Numerical data will be described as median
and interquartile range or range or mean and standard deviation as appropriate, while
qualitative data were described as number and percentage. Chi-square (Fisher's exact) test
was used to examine the relation between qualitative variables as appropriate. Testing for
normality was done using Kolmogrov-Smirnov test and Shapiro-Wilk test
