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

NCT02825056 | Unknown Early Phase 1 DMC

• 1 other identifier: NK/2676/DM/397
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vasoplegia

Outcome Measures

Primary Outcomes (1)

• incidence of Vasoplegia

  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)

  within 48 hours in post-operative period

Secondary Outcomes (5)

• Mechanical ventilation duration.

  post-operative 48 hours

• Time to extubation

  within 48 hours in post-operative period

• Requirement of postoperative analgesia based on VAS

  upto 48 hours of postoperative period

• Spirometry performance

  Upto 48 postoperative hours.

• incidence of awareness under anesthesia

  within 48 postoperative hours.

Study Arms (2)

Bupivacaine

ACTIVE COMPARATOR

Intrathecal 8 ml single dose of 0.5% heavy Bupivacaine (Anawin heavy 0.5%).

Drug: Bupivacaine

Bupivacaine + Morphine

EXPERIMENTAL

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

Interventions

Bupivacaine DRUG

Intrathecal local anesthetic drug,Bupivacaine will be delivered in L3-L4 space.

Also known as: Anawin heavy 0.5%,Neon laboratories LTD, Thane, India.

Bupivacaine

Bupivacaine + Morphine DRUG

Intrathecal local anesthetic drug,Bupivacaine and Morphine will be delivered in L3-L4 space.

Also known as: Anawin heavy 0.5%,and VERMOR 15,Verve, Delhi, India

Bupivacaine + Morphine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Related Publications (1)

• Bhat I, Arya VK, Mandal B, Jayant A, Dutta V, Rana SS. Postoperative hemodynamics after high spinal block with or without intrathecal morphine in cardiac surgical patients: a randomized-controlled trial. Can J Anaesth. 2021 Jun;68(6):825-834. doi: 10.1007/s12630-021-01937-z. Epub 2021 Feb 9.

  PMID: 33564993 DERIVED

MeSH Terms

Conditions

Vasoplegia

Interventions

Bupivacaine; Morphine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post operative hemodynamic investigator

Study Record Dates

• First Submitted: June 19, 2016
• First Posted: July 7, 2016
• Study Start: July 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 7, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share