Different Modalities of Analgesia in Open Heart Surgeries in Mansoura University

M

Mansoura University

Status and phase

Unknown
Phase 4

Conditions

Coronary Artery Disease
Pain, Acute
Pain, Postoperative
Valve Disease, Heart

Treatments

Drug: Fentanyl
Drug: Dexmedetomidine, Ketamine, Magnesium sulfate
Drug: Fentanyl, Propofol

Study type

Interventional

Funder types

Other

Identifiers

NCT04223219
MD.19.11.255

Details and patient eligibility

About

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.

Full description

Pain after cardiac surgery is triggered by numerous factors including skin incision, sternotomy, sternal and rib retraction, internal mammary artery and saphenous vein harvesting, surgical manipulation of pleura, placement of chest tubes and tissue trauma during surgery.Median sternotomy significantly reduces postoperative pulmonary function; however, it is the most commonly used approach because it facilitates exposure of the surgical field. Pain prevents early mobilization, reduction in pulmonary function and accumulation of bronchial secretions resulting in atelectasis, pulmonary infections, hypoxia and increase duration of ICU stay.Prolonged ICU stay is associated with greater risk of respiratory and renal dysfunction, and increases morbidity and mortality. Optimal post-operative pain management allows early weaning from mechanical ventilation and extubation, early mobilization, facilitate beginning of chest physiotherapy, shortens the length of ICU stay and hospitalization, medical costs and decreases incidence of post-operative complications. Opioid infusions and patient-controlled analgesia (PCA) remain the principal and most commonly used for immediate postoperative analgesia after cardiac surgery in Intensive Care Units. Multimodal opioid sparing analgesia has become frequently used. They are used for the opioids sparing effect and for achievement of a more efficient pain management via both central and peripheral anti-nociceptive mechanisms. Dexmedetomidine is an intravenous α-2 agonist widely used for sedation, anxiolysis and for augmenting anesthesia and analgesia with reduction in opioid requirements. Ketamine have a great analgesic effect and can be added to multimodal regimen. Magnesium can be added to multimodal regimen as it acts as a non-competitive antagonist of N-methyl-D-aspartate (NMDA) receptors and has anti-inflammatory effects and can be used in acute pain management. The aim of this study is to compare between traditional high opioid, low opioid and non-opioid technique on the patient outcome. This prospective randomized comparative study will be conducted on 75 patients undergoing cardiac procedures that will require cardiopulmonary bypass and median sternotomy at Cardiothoracic Surgical Department, Mansoura University Hospitals over 24 months. Eligible 90 patients will be randomly allocated to one of three equal groups each contains 25 patients, they will be randomized according to computer-generated randomization sequence: Either high opioid group (group I), Low opioid group (group II) and non-opioid group (group III).

Enrollment

90 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

90 participants in 3 patient groups, including a placebo group

High Opioid Group
Active Comparator group
Description:
-The patients will receive fentanyl infusion at a rate of 1 µg/kg/h and fentanyl bolus 20-40 µg according to patient hemodynamics. (tachycardia: increase of heart rate >20% of baseline or hypertension: increase of mean blood pressure >20% of baseline).
Treatment:
Drug: Fentanyl
Low Opioid Group
Placebo Comparator group
Description:
The patients will receive fentanyl bolus 20 µg/hr and propofol 20 mg at the time of surgical stimulation and according to patient hemodynamics (repeated as required).
Treatment:
Drug: Fentanyl, Propofol
Non-Opioid Group
Experimental group
Description:
The patients will receive infusions of dexmedetomidine 0.2 µg/kg/h, ketamine 2 µg/kg/min, and magnesium sulfate 5 mg/kg/h.
Treatment:
Drug: Dexmedetomidine, Ketamine, Magnesium sulfate

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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