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

NCT05320705 | Unknown Phase 1 FDA Drug

• 1 other identifier: N-17-2022
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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:

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

Conditions

Postoperative Atrial Fibrillation

Outcome Measures

Primary Outcomes (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.

  it will be measured in the first 72 hours postoperative

Secondary Outcomes (1)

• The incidence of Dexmedetomidine side effects in the first 72 hours postoperative

  it will be measured in the first 72 hours postoperative

Study Arms (2)

dexmedetomidine

ACTIVE COMPARATOR

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

Drug: Intra Operative Dexmedetomidine

normal saline placebo

PLACEBO COMPARATOR

similar bolus and infusion volumes of normal saline will be administered

Drug: Intra Operative Dexmedetomidine

Interventions

Intra Operative Dexmedetomidine DRUG

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.

Also known as: intra operative precedex

dexmedetomidine; normal saline placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Alainy, Cairo University

Cairo, 202, Egypt

RECRUITING

Study Officials

• Ahmed nabih, lecturer

  Anesthesia department , Cairo university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed nabih, lecturer

CONTACT

01002773488; nabihomar100@yahoo.com

mohamed abdel ghany, lecturer

CONTACT

01016109777; dr.mohmed.elshazly8686@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia

Study Record Dates

• First Submitted: April 2, 2022
• First Posted: April 11, 2022
• Study Start: April 15, 2022
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: May 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)