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Postoperative Atrial FibrillationPhase 1NCT05320705

The Effect of Intra Operative Dexmedetomidine in Prevention of Early Postoperative Atrial Fibrillation

A Phase 1 study testing Intra Operative Dexmedetomidine in people with Postoperative Atrial Fibrillation, run by Kasr El Aini Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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 incidence of atrial fibrillation (AF) after lung resection varies between 12% and 30% after lobectomy and 23%-67% after pneumonectomy. The average time of onset of AF after lung resection is 2-3 days. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Postoperative Atrial Fibrillation
What is being tested?
Intra Operative Dexmedetomidine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
350 participants
Where
1 siteEgypt
Study dates
15 Apr 2022to Sep 2022
Phase
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 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Gender both males and females
  • ASA Class II
  • Age 18-70 years
  • Patients undergoing thoracic non cardiac surgeries(lobectomy, pneumonectomy, and esophagectomy).

Who cannot join

  • Hypersensitivity or known allergy to dexmedetomidine. b.Patients with Sick-sinus orWolff-Parkinson-White syndromes; atrioventricular block atrial fibrillation within 30 days; a permanent pacemaker; used amiodarone or dexmedetomidine within30 days.
  • Patients with echocardiographic finding of an ejection fraction <30% and left atrial diameter more than 45mm and use of beta blockers or statins.
  • Liver and renal impairment(elevated liver enzymes (ALT, AST two to three fold), CRF ) e .Emergency operations ,video assisted thoracic surgeries and operation for spontaneous pneumothorax

Trial locations and contacts

1 site in 1 country.

Ahmed nabih, lecturer contact

01002773488 ext. 202

nabihomar100@yahoo.com

mohamed abdel ghany, lecturer contact

01016109777 ext. 202

dr.mohmed.elshazly8686@gmail.com

Egypt1 site, 1 recruiting
  • Kasr Alainy, Cairo University

    Cairo, 202

    Ahmed nabih, lecturer, 01002773488 ext. 202, nabihomar100@yahoo.com

    Recruiting

Other trials in Egypt

About this study

Official title: The Effect of Intra Operative Dexmedetomidine in Prevention of Early Postoperative Atrial Fibrillation in Patients Undergoing Thoracic Non Cardiac Surgeries: a Randomized Controlled Trial

The incidence of atrial fibrillation (AF) after lung resection varies between 12% and 30% after lobectomy and 23%-67% after pneumonectomy. The average time of onset of AF after lung resection is 2-3 days. AF after pulmonary resection can cause symptoms, hemodynamic instability, and stroke.Furthermore, AF following pulmonary resection may triple the mean duration stay in the intensive care unit and increase the total length of hospital stay by 2-9 days, with an increased in associated hospitalization costs.lastly, AF after lung resection has been associated with an increased risk of mortality , although the arrhythmia is more likely to be a consequence of other associated cardiopulmonary complications, rather than the main cause of death.

our study aim to assess the role of intra operative dexmedetomidine in reduction of early postoperative atrial fibrillation in patients undergoing thoracic non cardiac surgeries.

Read more

Objectives:

  1. To evaluate possible efficacy of intraoperative dexmedetomidine in reduction of postoperative atrial fibrillation in patients undergoing thoracic non cardiac surgeries
  2. To determine the incidence of new-onset atrial fibrillation after thoracic non cardiac surgeries in patients given intra operative dexmedetomidine
Read the detailed description

This a randomized control trial is designed to include (350) patients ASA physical status II patients ranging from(18) to(70)years old scheduled for thoracic non cardiac surgeries

Patients meeting the inclusion criteria will be randomly assigned to receive either :

Group I : dexmedetomidine: (n=175) dexmedetomidine will be administered as a bolus dose, before the surgical incision with 1mcg/kg iv over 10 minutes followed by infusion rate of 0.5 μg/kg per h and stopped at the end of operation.

GroupII: normal saline placebo:(n=175) similar bolus and infusion volumes of normal saline will be administered as dexmedetomidine group

Anesthesia management

Preoperative procedures:

Full history and investigation will be taken in the form of CBC, blood sugar ,liver function tests. Kidney function tests ,electrolytes and coagulation profile Preoperative awake supine trans thoracic echocardiograms will be performed before operation using a 2.5/2.0- MHz transducer for imaging and Doppler echocardiography. Preoperative 12-leads will be performed to all patients. On arrival of the patient to the operating theatre and before induction of anesthesia, all standard monitors will be applied, including heart rate (HR), ECG, oxygen saturation (SpO2), end-tidal CO2, arterial blood pressure (systolic, diastolic, and MAP), and temperature, arterial catheter will be inserted in the radial artery for continuous blood pressure monitoring and frequent blood gas analysis. Initial readings of all these monitors will be taken and recorded before starting any drug infusion. After securing IV access by 20G cannula, all patients will be premedicated with 0.05mg/kg midazolam for anxiety, antibiotic 50mg/kg.

Intraoperative procedures:

Induction of general anesthesia will be done by fentanyl 2ug/kg/ iv, 2mg \kg propofol, and 0.5mg\kg atracurium to facilitate endotracheal intubation. Anesthesia maintenance will be achieved with endotracheal tube with suitable size, 1.2 minimum alveolar concentration of isoflurane, volume controlled mode ventilation, respiratory rate will be adjusted according to Et CO2 to range between 35-40 mmHg, a tidal volume of 6-8 ml/kg and mixture of gases in proportion 50% oxygen and 50% air, with PEEP 5 cm H2O and0.1 mg\kg atracurium every 30 min.10mg morphine intravenous will be given after induction and intubation.

Intervention Dexmedetomidine will be administered as a bolus dose, before the surgical incision with 1mcg/kg iv in 100 ml saline solution over 10 minutes followed by infusion rate of 0.5 μg/kg per h infusion via syringe pump during surgery and stopped at the end of operation. Similar bolus and infusion volumes of normal saline will be administered in the Control group (placebo) However, anaesthesiologists will be permitted to reduce dose of the study drug as necessary to preserve haemodynamic stability(systolic blood pressure decrease more than 20% from the baseline or\ and heart rate less than 60 ). with occurence of bradycardia and \or hypotension it will be managed by the attending anesthesiologist according to standard institutional guidelines and drug infusion rate will be decreased to the half. if bradycardia or hypotension persisted, drug infusion will be unblinded, stopped and reported as a serious side effect occured with drug infusion .By the end of surgery, anaesthesia will be discontinued ,patient will be reversed by neostigmine 0.05mg\kg and atropine0.02mg\kg, extubation will be done and patient will be transferred to post anaesthesia care unit (PACU).

Postoperative

  1. Postoperative analgesia will be started with continuous infusion of 30 mg morphine associated with 180 mg ketorolac in 250 ml of normal saline at 5 ml /h and paracetamol infusion 1 g every 6 h. Additional bolus dose of 0.04mg/kg if vas exceed or equal 4 and it will be repeated if pain exist every 6 hours. All patients will be continuously monitored by 5-leads ECG and pulse oximeter(oxygen saturation) .12-leads ECG will be performed in occurence of tachycardia or arrythmia for the first 72 hours. Diagnoses of atrial fibrillation in the cardiac ICU will be made by clinicians who will be masked to group allocation. Atrial fibrillation will be defined by: clinician diagnosis; documented arrhythmia lasting at least 5 min ( supraventricular tachyarrhythmia characterized by uncoordinated atrial activation .Electrocardiographic findings include the replacement of the normal consistent p waves with oscillatory or fibrillatory waves of different sizes amplitudes and timing with narrow QRS complex unless other conduction abnormalities exist ( e.g. bundle branch block , accessory pathways). The ventricular response is often rapid and between 90 and 170 beats per minute and it will be documented by 12- lead ECG.
  2. Post operative haemodynamic will be assessed (heart rate , ,systolic and diastolic blood pressure every 2 hours or with the occurrence of dysrhythmia)
  3. Serial cardiac enzymes concentration (CK MB , Troponin ) will be measured every 6 h to rule out myocardial infarction.
Being tested
Intra Operative Dexmedetomidine

What participants receive

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

  • Intra Operative DexmedetomidineDrug

    Also called intra operative precedex

    Dexmedetomidine will be administered as a bolus dose, before the surgical incision with 1mcg/kg iv in 100 ml saline solution over 10 minutes followed by infusion rate of 0.5 μg/kg per h infusion via syringe pump during surgery and stopped at the end of operation. Similar bolus and infusion volumes of normal saline will be administered in the Control group (placebo) However, anaesthesiologists will be permitted to reduce dose of the study drug as necessary to preserve haemodynamic stability.

Study groups in NCT05320705
Study groupRoleWhat they receive
dexmedetomidineActive comparatordexmedetomidine will be administered as a bolus dose, before the surgical incision, followed by infusion and stopped at the end of operation
Receives: Drug: Intra Operative Dexmedetomidine
normal saline placeboPlacebo comparatorsimilar bolus and infusion volumes of normal saline will be administered
Receives: Drug: Intra Operative Dexmedetomidine

What is being measured

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

  1. Incidence of new onset early atrial fibrillation following thoracic non cardiac surgeries in the first 72 hours postoperative

    Diagnoses of atrial fibrillation in the cardiac ICU will be made by clinicians who will be masked to group allocation. Atrial fibrillation will be defined by: clinician diagnosis; documented arrhythmia lasting at least 5 min ( supraventricular tachyarrhythmia characterized by uncoordinated atrial activation .Electrocardiographic findings include the replacement of the normal consistent p waves with oscillatory or fibrillatory waves of different sizes amplitudes and timing with narrow QRS complex.The ventricular response is often rapid and between 90 and 170 beats per minute and it will be documented by 12- lead ECG.

    Measured: it will be measured in the first 72 hours postoperative

Secondary outcomes (1)
  1. The incidence of Dexmedetomidine side effects in the first 72 hours postoperative

    (hypotension , nausea , vomiting, dry mouth , bradycardia (HR <60 beats/ min), pyrexia, chills, hyperglycemia, hypocalcemia and acidosis.

    Measured: it will be measured in the first 72 hours postoperative

Timeline

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

  1. First posted11 Apr 2022
  2. Study start15 Apr 2022
  3. Primary completionSep 2022 (estimated)
  4. Study completionSep 2022 (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
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05320705
Sponsor's protocol ID
N-17-2022
Status last verified
May 2022
First submitted
2 Apr 2022
Last updated
10 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Intra Operative Dexmedetomidine in people with Postoperative Atrial Fibrillation, run by Kasr El Aini Hospital 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 4 inclusion and 3 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 May 2022. 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. Some participants in this study may receive a placebo. 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Ahmed nabih, lecturer (01002773488 ext. 202, nabihomar100@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of new onset early atrial fibrillation following thoracic non cardiac surgeries in the first 72 hours postoperative (time frame: it will be measured in the first 72 hours postoperative). 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 May 2022.

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