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Postoperative Hemodynamics Comparison After High Spinal Block With or Without Intrathecal Morphine.

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ClinicalTrials.gov Identifier: NCT02825056
Recruitment Status : Unknown
Verified July 2016 by IMRAN HUSSAIN BHAT, Postgraduate Institute of Medical Education and Research.
Recruitment status was:  Not yet recruiting
First Posted : July 7, 2016
Last Update Posted : July 7, 2016
Sponsor:
Information provided by (Responsible Party):
IMRAN HUSSAIN BHAT, Postgraduate Institute of Medical Education and Research

Brief Summary:
There is paucity of literature on the effects of intrathecal morphine on the postoperative hemodynamics in the cardiac-surgical patients.We planned this study to compare the post-operative hemodynamic effects (particularly the incidence of vasoplegia in the two study groups) and outcome of combined general anesthesia + high spinal block, with or without intrathecal morphine in patients undergoing cardiac-surgical procedures in our set up.

Condition or disease Intervention/treatment Phase
Vasoplegia Drug: Bupivacaine Drug: Bupivacaine + Morphine Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Comparison of Postoperative Hemodynamics After High Spinal Block With or Without Intrathecal Morphine in Cardiac Surgeries.
Study Start Date : July 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

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Arm Intervention/treatment
Active Comparator: Bupivacaine
Intrathecal 8 ml single dose of 0.5% heavy Bupivacaine (Anawin heavy 0.5%).
Drug: Bupivacaine
Intrathecal local anesthetic drug,Bupivacaine will be delivered in L3-L4 space.
Other Name: Anawin heavy 0.5%,Neon laboratories LTD, Thane, India.

Experimental: Bupivacaine + Morphine
Intrathecal 8 ml single dose of 0.5% heavy Bupivacaine (Anawin heavy 0.5%) and 250 microgram of preservative free Morphine (VERMOR).
Drug: Bupivacaine + Morphine
Intrathecal local anesthetic drug,Bupivacaine and Morphine will be delivered in L3-L4 space.
Other Name: Anawin heavy 0.5%,and VERMOR 15,Verve, Delhi, India




Primary Outcome Measures :
  1. incidence of Vasoplegia [ Time Frame: within 48 hours in post-operative period ]
    Vasoplegia (defined by MAP < 60mmHg with cardiac index > 2.2L/min/m2 or requirement of vasopressors to maintain the MAP > 60 mmHg in presence of cardiac index > 2.2L/min/m2)


Secondary Outcome Measures :
  1. Mechanical ventilation duration. [ Time Frame: post-operative 48 hours ]
    Hours of mechanical ventilation shall be noted for each patient and compared between the groups.

  2. Time to extubation [ Time Frame: within 48 hours in post-operative period ]
    Fast tracking (extubation within 6-8 hours of mechanical ventilation duration) or failure of fast tracking would be noted.

  3. Requirement of postoperative analgesia based on VAS [ Time Frame: upto 48 hours of postoperative period ]
    Rescue analgesic/s in the form of opioids/non-opioids will be administered if the VAS score exceeds 4 and note of drug and dose made.

  4. Spirometry performance [ Time Frame: Upto 48 postoperative hours. ]
    Two spirometry readings, one after extubation and another at 48 hours of postoperative period will be recorded

  5. incidence of awareness under anesthesia [ Time Frame: within 48 postoperative hours. ]
    Structured Brice and Bauer questionnaire shall be used to assess for intraoperative awareness.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: - Adult patients with valvular heart disease and coronary artery disease of New York Heart Association class II-III aged 18 to 60 years undergoing elective cardiac surgery (Valve replacement/CABG).

Exclusion Criteria:

  • • All the standard contraindications for spinal anaesthesia which includes local site infection, spinal deformity, coagulopathy (platelet count<80,000, INR>1.5) patients on anticoagulant medication continued upto the day of the surgery as per the third edition of the American Society of Regional Anesthesia and Pain Medicine Evidence-Based Guidelines (Regional Anesthesia in the Patient Receiving Antithrombotic or Thrombolytic Therapy)

    • Redo surgery/emergency surgeries.
    • Patients having co-morbidities such as obesity (BMI more than 30), COPD, asthma, that are likely to require prolonged post operative mechanical ventilation.
    • Total surgery time > 6 hours.
    • History of opioid drug abuse or patients on opioids for treatment of chronic pain.
    • Known or anticipated difficult airway
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Responsible Party: IMRAN HUSSAIN BHAT, Post operative hemodynamic investigator, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT02825056    
Other Study ID Numbers: NK/2676/DM/397
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: July 7, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual patient data will be furnished once asked for.
Additional relevant MeSH terms:
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Vasoplegia
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Pathologic Processes
Morphine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics