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Different Modalities of Analgesia in Open Heart Surgeries in Mansoura University

Primary Purpose

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

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Fentanyl
Fentanyl, Propofol
Dexmedetomidine, Ketamine, Magnesium sulfate
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Mansoura Faculty of medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Experimental

Arm Label

High Opioid Group

Low Opioid Group

Non-Opioid Group

Arm 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).

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).

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Heart rate
Systolic blood pressure
Diastolic blood pressure
Mean arterial blood pressure
Total opioid consumption
calculation of total opioids used intra operative and pos operative
Time to tracheal extubation
Duration of ICU stay
Time to either bowel movement or flatus
Number of participants with post-operative nausea and vomiting (PONV)
Doses of atropine required
Doses of Inotropic required
Doses of vasopressors required

Full Information

First Posted
December 28, 2019
Last Updated
September 16, 2021
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT04223219
Brief Title
Different Modalities of Analgesia in Open Heart Surgeries in Mansoura University
Official Title
Different Modalities of Analgesia in Open Heart Surgeries in Mansoura University: Randomized Prospective Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
August 15, 2021 (Actual)
Study Completion Date
September 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Valve Disease, Heart, Pain, Acute, Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Opioid Group
Arm Type
Active Comparator
Arm 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).
Arm Title
Low Opioid Group
Arm Type
Placebo Comparator
Arm 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).
Arm Title
Non-Opioid Group
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Fentanyl, Propofol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine, Ketamine, Magnesium sulfate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain score at rest assessed using the visual analogue scale.
Description
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
Time Frame
30 minutes after tracheal extubation
Secondary Outcome Measure Information:
Title
Pain score at rest assessed using the visual analogue scale.
Description
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
Time Frame
2, 6, 12, and 24 hours after tracheal extubation
Title
Sedation level assessed using Ramsay sedation score
Description
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
Time Frame
30 minutes, 2, 6, 12, and 24 hours after tracheal extubation
Title
Heart rate
Time Frame
every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative
Title
Systolic blood pressure
Time Frame
every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative
Title
Diastolic blood pressure
Time Frame
every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative
Title
Mean arterial blood pressure
Time Frame
every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative
Title
Total opioid consumption
Description
calculation of total opioids used intra operative and pos operative
Time Frame
24 hours post operative
Title
Time to tracheal extubation
Time Frame
2 hours to 6 hours
Title
Duration of ICU stay
Time Frame
2 to 5 days
Title
Time to either bowel movement or flatus
Time Frame
within 24 hours
Title
Number of participants with post-operative nausea and vomiting (PONV)
Time Frame
within 24 hours
Title
Doses of atropine required
Time Frame
from start to the end of surgery
Title
Doses of Inotropic required
Time Frame
from start to the end of surgery
Title
Doses of vasopressors required
Time Frame
from start to the end of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Mansoura Faculty of medicine
City
Mansoura
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Different Modalities of Analgesia in Open Heart Surgeries in Mansoura University

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