Coronary Artery Disease Clinical Trial
Official title:
Different Modalities of Analgesia in Open Heart Surgeries in Mansoura University: Randomized Prospective Comparative Study
Verified date | September 2021 |
Source | Mansoura University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Cardiac surgery is associated with post-operative pain which is one of the major problems and remains one of the most controversial issues. Inadequate pain control after cardiac surgery increases the incidence of development of many complications. Intravenous opioids are commonly used for postoperative analgesia either on demand "physician or nurse-controlled" or patient -controlled. Multimodal opioid sparing analgesia has become frequently used, These techniques can be achieved with Dexmedetomidine, low-dose ketamine and magnesium. The study hypotheses that control of perioperative quality of pain with opioid sparing medications may improve analgesia and patient outcome.
Status | Active, not recruiting |
Enrollment | 90 |
Est. completion date | September 15, 2021 |
Est. primary completion date | August 15, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult patients of both gender, - Aged above 18 years - American Society of Anesthesiologists (ASA) physical status II & III, - Body mass index less than 40 kg/m2 - Scheduled for any cardiac procedure with median sternotomy that require cardiopulmonary bypass at Cardiothoracic Surgical Department, Mansoura University Hospitals. Exclusion Criteria: - Patients with pulmonary dysfunction or chronic obstructive pulmonary diseases - Acute or unstable angina - Previous cardio-thoracic surgery - Emergency surgery - Left ventricular ejection fraction less than 40% - Dysrhythmia or pacemaker - Major hepatic or renal dysfunction - Need for re-exploration, uncontrolled diabetes (HbA1c > 8.5) - Neurological deficit - Hyper-magnesemia |
Country | Name | City | State |
---|---|---|---|
Egypt | Mansoura Faculty of medicine | Mansoura |
Lead Sponsor | Collaborator |
---|---|
Mansoura University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain score at rest assessed using the visual analogue scale. | visual analogue scale is a straight horizontal line of fixed length, usually 100 mm. orientated from the left (worst) to the right (best) (where 0 is no pain and 100 is the worst pain) lower score means better outcome | 30 minutes after tracheal extubation | |
Secondary | Pain score at rest assessed using the visual analogue scale. | visual analogue scale is a straight horizontal line of fixed length, usually 100 mm. orientated from the left (worst) to the right (best) (where 0 is no pain and 100 is the worst pain) lower score means better outcome | 2, 6, 12, and 24 hours after tracheal extubation | |
Secondary | Sedation level assessed using Ramsay sedation score | Ramsay sedation score used to assess level of sedation range from 1 to 6 where (1: awake, anxious, agitated, restless, 2: awake, cooperative, orientated, and tranquil, 3: responsive to commands only, 4: asleep, brisk response to light glabellar tap or loud auditory stimulus, 5: asleep, sluggish response to light glabellar tap or loud auditory stimulus and, 6: no response to light glabellar tap or loud auditory stimulus).
lower score means better outcome |
30 minutes, 2, 6, 12, and 24 hours after tracheal extubation | |
Secondary | Heart rate | every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative | ||
Secondary | Systolic blood pressure | every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative | ||
Secondary | Diastolic blood pressure | every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative | ||
Secondary | Mean arterial blood pressure | every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative | ||
Secondary | Total opioid consumption | calculation of total opioids used intra operative and pos operative | 24 hours post operative | |
Secondary | Time to tracheal extubation | 2 hours to 6 hours | ||
Secondary | Duration of ICU stay | 2 to 5 days | ||
Secondary | Time to either bowel movement or flatus | within 24 hours | ||
Secondary | Number of participants with post-operative nausea and vomiting (PONV) | within 24 hours | ||
Secondary | Doses of atropine required | from start to the end of surgery | ||
Secondary | Doses of Inotropic required | from start to the end of surgery | ||
Secondary | Doses of vasopressors required | from start to the end of surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06030596 -
SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
|
||
Completed |
NCT04080700 -
Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
|
||
Recruiting |
NCT03810599 -
Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study
|
N/A | |
Recruiting |
NCT06002932 -
Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.
|
N/A | |
Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
Recruiting |
NCT04242134 -
Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions
|
N/A | |
Recruiting |
NCT05308719 -
Nasal Oxygen Therapy After Cardiac Surgery
|
N/A | |
Completed |
NCT04556994 -
Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients.
|
N/A | |
Recruiting |
NCT05846893 -
Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
|
N/A | |
Recruiting |
NCT06027788 -
CTSN Embolic Protection Trial
|
N/A | |
Recruiting |
NCT05023629 -
STunning After Balloon Occlusion
|
N/A | |
Completed |
NCT04941560 -
Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
|
||
Completed |
NCT04006288 -
Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease
|
Phase 4 | |
Completed |
NCT01860274 -
Meshed Vein Graft Patency Trial - VEST
|
N/A | |
Recruiting |
NCT06174090 -
The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients
|
N/A | |
Completed |
NCT03968809 -
Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
|
||
Terminated |
NCT03959072 -
Cardiac Cath Lab Staff Radiation Exposure
|
||
Recruiting |
NCT04566497 -
Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up.
|
N/A | |
Recruiting |
NCT05065073 -
Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography
|
Phase 4 | |
Completed |
NCT05096442 -
Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions
|
N/A |