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

Primary Purpose

Postoperative Atrial Fibrillation

Status
Recruiting
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Intra Operative Dexmedetomidine
Sponsored by
Kasr El Aini Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Atrial Fibrillation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

A. 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.

c. Patients with echocardiographic finding of an ejection fraction <30% and left atrial diameter more than 45mm and use of beta blockers or statins.

d. 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

Sites / Locations

  • Kasr Alainy, Cairo UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

dexmedetomidine

normal saline placebo

Arm Description

dexmedetomidine will be administered as a bolus dose, before the surgical incision, followed by infusion and stopped at the end of operation

similar bolus and infusion volumes of normal saline will be administered

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 2, 2022
Last Updated
May 7, 2022
Sponsor
Kasr El Aini Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05320705
Brief Title
The Effect of Intra Operative Dexmedetomidine in Prevention of Early Postoperative Atrial Fibrillation
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2022 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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. 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. Objectives: To evaluate possible efficacy of intraoperative dexmedetomidine in reduction of postoperative atrial fibrillation in patients undergoing thoracic non cardiac surgeries To determine the incidence of new-onset atrial fibrillation after thoracic non cardiac surgeries in patients given intra operative dexmedetomidine
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 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. Post operative haemodynamic will be assessed (heart rate , ,systolic and diastolic blood pressure every 2 hours or with the occurrence of dysrhythmia) Serial cardiac enzymes concentration (CK MB , Troponin ) will be measured every 6 h to rule out myocardial infarction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Atrial Fibrillation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Randomization will be done by computer generated numbers and concealed by serially numbered, opaque and sealed envelopes. The details of the series will be unknown to the investigators and the group assignment will be kept in asset of sealed envelopes each bearing only the case number on the outside. Prior to surgery the appropriate numbered envelopes will be opened by the nurse, the card inside will determine the patient group
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
dexmedetomidine
Arm Type
Active Comparator
Arm Description
dexmedetomidine will be administered as a bolus dose, before the surgical incision, followed by infusion and stopped at the end of operation
Arm Title
normal saline placebo
Arm Type
Placebo Comparator
Arm Description
similar bolus and infusion volumes of normal saline will be administered
Intervention Type
Drug
Intervention Name(s)
Intra Operative Dexmedetomidine
Other Intervention Name(s)
intra operative precedex
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of new onset early atrial fibrillation following thoracic non cardiac surgeries in the first 72 hours postoperative
Description
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.
Time Frame
it will be measured in the first 72 hours postoperative
Secondary Outcome Measure Information:
Title
The incidence of Dexmedetomidine side effects in the first 72 hours postoperative
Description
(hypotension , nausea , vomiting, dry mouth , bradycardia (HR <60 beats/ min), pyrexia, chills, hyperglycemia, hypocalcemia and acidosis.
Time Frame
it will be measured in the first 72 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Gender both males and females ASA Class II Age 18-70 years Patients undergoing thoracic non cardiac surgeries(lobectomy, pneumonectomy, and esophagectomy). Exclusion Criteria: A. 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. c. Patients with echocardiographic finding of an ejection fraction <30% and left atrial diameter more than 45mm and use of beta blockers or statins. d. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed nabih, lecturer
Phone
01002773488
Ext
202
Email
nabihomar100@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
mohamed abdel ghany, lecturer
Phone
01016109777
Ext
202
Email
dr.mohmed.elshazly8686@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed nabih, lecturer
Organizational Affiliation
Anesthesia department , Cairo university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy, Cairo University
City
Cairo
ZIP/Postal Code
202
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed nabih, lecturer
Phone
01002773488
Ext
202
Email
nabihomar100@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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