Different Modalities of Analgesia in Open Heart Surgeries in Mansoura University

NCT04223219 | Unknown Phase 4

• 1 other identifier: MD.19.11.255
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Pain score at rest assessed using the visual analogue scale.

  2, 6, 12, and 24 hours after tracheal extubation

• Sedation level assessed using Ramsay sedation score

  30 minutes, 2, 6, 12, and 24 hours after tracheal extubation

• Heart rate

  every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative

• Systolic blood pressure

  every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative

• Diastolic blood pressure

  every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative

Study Arms (3)

High Opioid Group

ACTIVE COMPARATOR

-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).

Drug: Fentanyl

Low Opioid Group

PLACEBO COMPARATOR

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).

Drug: Fentanyl, Propofol

Non-Opioid Group

EXPERIMENTAL

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

Drug: Dexmedetomidine, Ketamine, Magnesium sulfate

Interventions

Fentanyl DRUG

* 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.

High Opioid Group

Fentanyl, Propofol DRUG

* 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.

Low Opioid Group

Dexmedetomidine, Ketamine, Magnesium sulfate DRUG

* 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.

Non-Opioid Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura Faculty of medicine

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

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

Interventions

Fentanyl; Propofol; Dexmedetomidine; Ketamine; Magnesium Sulfate

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: December 28, 2019
• First Posted: January 10, 2020
• Study Start: December 10, 2019
• Primary Completion: August 15, 2021
• Study Completion: September 15, 2021
• Last Updated: September 22, 2021

Record last verified: 2021-09

Locations

EG (1)