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Different Modalities of Analgesia in Open Heart Surgeries in Mansoura University

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ClinicalTrials.gov Identifier: NCT04223219
Recruitment Status : Active, not recruiting
First Posted : January 10, 2020
Last Update Posted : September 22, 2021
Sponsor:
Information provided by (Responsible Party):
Ahmed Gamal Morsy, Mansoura University

Tracking Information
First Submitted Date  ICMJE December 28, 2019
First Posted Date  ICMJE January 10, 2020
Last Update Posted Date September 22, 2021
Actual Study Start Date  ICMJE December 10, 2019
Actual Primary Completion Date August 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 7, 2020)
Pain score at rest assessed using the visual analogue scale. [ Time Frame: 30 minutes after tracheal extubation ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2020)
  • Pain score at rest assessed using the visual analogue scale. [ Time Frame: 2, 6, 12, and 24 hours after tracheal extubation ]
    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
  • Sedation level assessed using Ramsay sedation score [ Time Frame: 30 minutes, 2, 6, 12, and 24 hours after tracheal extubation ]
    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
  • Heart rate [ Time Frame: every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative ]
  • Systolic blood pressure [ Time Frame: every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative ]
  • Diastolic blood pressure [ Time Frame: every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative ]
  • Mean arterial blood pressure [ Time Frame: every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative ]
  • Total opioid consumption [ Time Frame: 24 hours post operative ]
    calculation of total opioids used intra operative and pos operative
  • Time to tracheal extubation [ Time Frame: 2 hours to 6 hours ]
  • Duration of ICU stay [ Time Frame: 2 to 5 days ]
  • Time to either bowel movement or flatus [ Time Frame: within 24 hours ]
  • Number of participants with post-operative nausea and vomiting (PONV) [ Time Frame: within 24 hours ]
  • Doses of atropine required [ Time Frame: from start to the end of surgery ]
  • Doses of Inotropic required [ Time Frame: from start to the end of surgery ]
  • Doses of vasopressors required [ Time Frame: from start to the end of surgery ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2020)
  • Pain score at rest assessed using the visual analogue scale. [ Time Frame: 2, 6, 12, and 24 hours after tracheal extubation ]
    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
  • Sedation level assessed using Ramsay sedation score [ Time Frame: 30 minutes, 2, 6, 12, and 24 hours after tracheal extubation ]
    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
  • Heart rate [ Time Frame: every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative ]
  • Systolic blood pressure [ Time Frame: every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative ]
  • Diastolic blood pressure [ Time Frame: every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative ]
  • Mean arterial blood pressure [ Time Frame: every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative ]
  • Total opioid consumption [ Time Frame: 24 hours post operative ]
    calculation of total opioids used intra operative and pos operative
  • Time to tracheal extubation [ Time Frame: 2 hours to 6 hours ]
  • Duration of ICU stay [ Time Frame: 2 to 5 days ]
  • Time to either bowel movement or flatus [ Time Frame: within 24 hours ]
  • Onset of mobilization [ Time Frame: within 24 hours ]
  • Number of participants with post-operative nausea and vomiting (PONV) [ Time Frame: within 24 hours ]
  • Doses of atropine required [ Time Frame: from start to the end of surgery ]
  • Doses of Inotropic required [ Time Frame: from start to the end of surgery ]
  • Doses of vasopressors required [ Time Frame: from start to the end of surgery ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Different Modalities of Analgesia in Open Heart Surgeries in Mansoura University
Official Title  ICMJE Different Modalities of Analgesia in Open Heart Surgeries in Mansoura University: Randomized Prospective Comparative Study
Brief Summary

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.

Detailed 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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
The study subjects will be blinded to the allocated groups. The outcome assessor (the investigator who will assess the primary and secondary outcomes) will be blinded to the allocated groups.
Primary Purpose: Treatment
Condition  ICMJE
  • Coronary Artery Disease
  • Valve Disease, Heart
  • Pain, Acute
  • Pain, Postoperative
Intervention  ICMJE
  • Drug: Fentanyl
    • Induction of anesthesia : Midazolam 2 mg, Fentanyl 3 µg/kg, propofol 50-100 mg and Atracurium 0.5 mg/kg.
    • Maintenance of anesthesia (intraoperative until tracheal extubation):

    Maintenance will be achieved by isoflurane with concentration 0.5-1.5 % with 40% oxygen. During cardiopulmonary bypass by continuous infusion of Propofol at a rate of 2 mg/kg/hr. and Atracurium at a rate of 10 g/kg/min.

    • 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 blood pressure >20% of baseline).
    • After tracheal extubation:

    all the patients will receive standard analgesia (i.v. paracetamol 1 gm every 12 hours and i.v. ketorolac 30 mg every 12 hours) and morphine patient controlled analgesia with bolus dose = 2 mg, lockout interval = 10 minutes, 4-hour dose limit = 10 mg, with no background infusion.

  • Drug: Fentanyl, Propofol
    • Induction of anesthesia : Midazolam 2 mg, Fentanyl 3 µg/kg, propofol 50-100 mg and Atracurium 0.5 mg/kg.
    • Maintenance of anesthesia (intraoperative until tracheal extubation):

    Maintenance of anesthesia will be achieved by isoflurane with concentration 0.5-1.5 % with 40% oxugen. During cardiopulmonary bypass by continuous infusion of Propofol at a rate of 2 mg/kg/hr. and Atracurium at a rate of 10 g/kg/min.

    • 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).
    • After tracheal extubation:

    all the patients will receive standard analgesia (i.v. paracetamol 1 gm every 12 hours and i.v. ketorolac 30 mg every 12 hours) and morphine patient controlled analgesia with bolus dose = 2 mg, lockout interval = 10 minutes, 4-hour dose limit = 10 mg, with no background infusion.

  • Drug: Dexmedetomidine, Ketamine, Magnesium sulfate
    • Induction of anesthesia : Midazolam 2 mg, Fentanyl 3 µg/kg, propofol 50-100 mg and Atracurium 0.5 mg/kg.
    • Maintenance of anesthesia (intraoperative until tracheal extubation):

    Maintenance of anesthesia will be achieved by isoflurane with concentration 0.5-1.5 % with 40% oxygen. During cardiopulmonary bypass by continuous infusion of Propofol at a rate of 2 mg/kg/hr. and Atracurium at a rate of 10 g/kg/min.

    • The patients will receive infusions of dexmedetomidine 0.2 µg/kg/h, ketamine 2 µg/kg/min, and magnesium sulfate 5 mg/kg/h.
    • After tracheal extubation:

    all the patients will receive standard analgesia (i.v. paracetamol 1 gm every 12 hours and i.v. ketorolac 30 mg every 12 hours) and morphine patient controlled analgesia with bolus dose = 2 mg, lockout interval = 10 minutes, 4-hour dose limit = 10 mg, with no background infusion.

Study Arms  ICMJE
  • Active Comparator: High Opioid Group
    -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).
    Intervention: Drug: Fentanyl
  • Placebo Comparator: Low Opioid Group
    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).
    Intervention: Drug: Fentanyl, Propofol
  • Experimental: Non-Opioid Group
    The patients will receive infusions of dexmedetomidine 0.2 µg/kg/h, ketamine 2 µg/kg/min, and magnesium sulfate 5 mg/kg/h.
    Intervention: Drug: Dexmedetomidine, Ketamine, Magnesium sulfate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 16, 2021)
90
Original Estimated Enrollment  ICMJE
 (submitted: January 7, 2020)
75
Estimated Study Completion Date  ICMJE September 15, 2021
Actual Primary Completion Date August 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04223219
Other Study ID Numbers  ICMJE MD.19.11.255
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Ahmed Gamal Morsy, Mansoura University
Study Sponsor  ICMJE Mansoura University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Mansoura University
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP