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
Postgraduate Institute of Medical Education and Research
Information provided by (Responsible Party):
IMRAN HUSSAIN BHAT, Postgraduate Institute of Medical Education and Research
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
Active Comparator: Bupivacaine
Intrathecal 8 ml single dose of 0.5% heavy Bupivacaine (Anawin heavy 0.5%).
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 :
- 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 :
- Mechanical ventilation duration. [ Time Frame: post-operative 48 hours ]Hours of mechanical ventilation shall be noted for each patient and compared between the groups.
- 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.
- 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.
- 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
- 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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