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Airway ResponsesEarly Phase 1NCT04659642

Attenuation of Airway and Cardiovascular Responses to Extubation in Chronic Smokers

A Early Phase 1 study testing Dexmedetomidine Injection [Precedex], Fentanyl Citrate Injection and dexmedetomidine and fentanyl in people with Airway Responses and Hemodynamic, run by National Cancer Institute, Egypt at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Ages 20 to 60 years, men only
Conditions the study is for
Airway Responses, Hemodynamic
What is being tested?
Dexmedetomidine Injection [Precedex], Fentanyl Citrate Injection and dexmedetomidine and fentanyl
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteEgypt
Study dates
30 Nov 2020to 20 Mar 2021
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 20 to 60 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Chronic cigarette smokers (patients have smoked for two years at least, and a minimum consumption of 10 cigarettes/ day)
  • American Society of Anesthesiologists (ASA) II.
  • Normotensive and receiving no medications
  • Body mass index of 30 kg/m2
  • Mallampati classification I-II

Who cannot join

  • History of opioid, sedative drugs or medications affecting heart rate or blood pressure.
  • Morbid obesity.
  • Current upper respiratory infection
  • Hypovolemia
  • IHD
  • History of sleep apnea or Difficult Intubation.
Show all 9Show fewer
  • Emergency procedures.
  • Hepatic or renal impairment.
  • Drug allergy to Dexmeditomidine or fentanyl.

Trial locations and contacts

1 site in 1 country.

asmaa abdulwahhab, M.sc contact

1212959293 ext. +(202)

asmafhmy@gmail.com

Egypt1 site, 1 recruiting
  • NCI, Cairo university

    Cairo

    asmaa abdulwahhab, M.sc, 1212959293 ext. +(202), asmafhmy@gmail.com

    Recruiting

Other trials in Egypt

About this study

Official title: Attenuation of Airway and Cardiovascular Responses to Extubation in Chronic Smokers by Prior Treatment With Dexmedetomidine, Fentanyl and Their Combination

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).

Read the detailed 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

Being tested
Dexmedetomidine Injection [Precedex], Fentanyl Citrate Injection, dexmedetomidine and fentanyl
Keywords
extubation, chronic smoker, dexmedetomidine, fentanyl, abdominal surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexmedetomidine Injection [Precedex]Drug

    the drug is given 15 minutes before the estimated end of surgery

  • Fentanyl Citrate InjectionDrug

    the drug is given 15 minutes before the estimated end of surgery

  • dexmedetomidine and fentanylCombination product

    the combination of the two drugs with the same used doses is given 15 minutes before the estimated end of surgery

Study groups in NCT04659642
Study groupRoleWhat they receive
dexmedetomidine group (group A)Active comparatorwill receive Dexmedetomidine 1ug/kg body weight IV diluted to 100ml normal saline (NS) over 15 minutes.
Receives: Drug: Dexmedetomidine Injection [Precedex]
Fentanyl group (group B)Active comparatorwill receive Fentanyl 1 ug/kg body weight IV diluted to 100 ml normal saline (NS) over 15 minutes.
Receives: Drug: Fentanyl Citrate Injection
Both Dexmedetomidine and fentanyl group (group C)Active comparatorwill receive both Dexmedetomidine 1ug/kg body weight mixed with fentanyl 1ug/kg in 100 ml normal saline (NS) over 15 minutes.
Receives: Combination Product: dexmedetomidine and fentanyl

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of extubation by extubation quality score

    1. No coughing
    2. Smooth extubation, minimal coughing (1 or 2 times)
    3. Moderate coughing (3 or 4 times)
    4. Severe coughing (5-10 times) and straining
    5. Poor extubation, very uncomfortable (laryngospasm and coughing >10 times).

    Measured: 5 minutes

  2. post extubation laryngospasm, bronchospasm or desaturation

    laryngospasm, bronchospasm or desaturation

    Measured: 30 minutes

Secondary outcomes (3)
  1. Time to extubation

    from inhaled anesthetic cut off to ETT removal

    Measured: up to 25 minutes

  2. Hemodynamic responses

    Bradycardia (was defined as HR < 60 /min and treated with rescue dose of injection atropine 0.6 mg intravenously), tachycardia (being 20% increase from baseline), hypertension (as either 20% increase from baseline or SBP > 180 mmHg) and hypotension (as 20% decrease from baseline or SBP < 80 mmHg).

    Measured: up to 60 minutes

  3. • Postoperative agitation and sedation were evaluated on a 10 points scale (RASS Scale)

    (+4) Combative, (+3) Very Agitated, (+2) Agitated, (+1) Restless, (0) Alert and Calm, (-1) Drowsy, (-2) Light sedation, (-3) Moderate sedation, (-4) Deep sedation, (-5) Unarousable.

    Measured: up to 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2020
  2. Study start30 Nov 2020
  3. Primary completion6 Mar 2021 (estimated)
  4. Study completion20 Mar 2021 (estimated)

Resources

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
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04659642
Sponsor's protocol ID
dexmedetomidine in anesthesia
Status last verified
Mar 2021
First submitted
24 Nov 2020
Last updated
10 Mar 2021
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Dexmedetomidine Injection [Precedex], Fentanyl Citrate Injection and dexmedetomidine and fentanyl in people with Airway Responses and Hemodynamic, run by National Cancer Institute, Egypt 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 10 Mar 2021. 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. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact asmaa abdulwahhab, M.sc (1212959293 ext. +(202), asmafhmy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of extubation by extubation quality score (time frame: 5 minutes). 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 10 Mar 2021.

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