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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
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

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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: IMRAN HUSSAIN BHAT, Post operative hemodynamic investigator, Postgraduate Institute of Medical Education and Research 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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Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Pathologic Processes
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid