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General Plus Spinal Anesthesia and General Anesthesia Alone on Right Ventricular Function

Primary Purpose

Right Ventricular Dysfunction

Status
Unknown status
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Spinal anesthesia with Bupivacaine heavy and Morphine
Bupivacaine heavy and Morphine
General Anesthetics
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Right Ventricular Dysfunction

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 50 consecutive patients of 18 to 60 years age,
  • NYHA class II or III,
  • with mitral valvular disease with moderate to severe PAH (mean pulmonary artery pressure > 40 mmHg) undergoing MVR

Exclusion Criteria:

  • emergency or redo surgery, patients with associated CAD or other valvular heart disease,
  • COPD,
  • bronchial asthma,
  • obesity (BMI more than 30), anticipated difficult airway,
  • opioid drug abuse or addiction and those with contraindication for spinal anaesthesia including local site infection,
  • spinal deformity, deranged coagulogram defined by platelet count < 80,000 & INR > 1.

Sites / Locations

  • PGIMERRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SPINAL PLUS GENERAL ANESTHESIA

ONLY GENERAL ANESTHESIA

Arm Description

Patient will receive the intervention SPINAL ANESTHESIA before the start of surgery using Bupivacaine heavy 40 mg and Morphine 250 micro grams comprising a total volume of 8 ml to achieve a spinal block up to T2 level followed by general anesthesia

Patient will receive only general anesthesia before the start of surgery

Outcomes

Primary Outcome Measures

Improvement of right ventricular function defined by 20% increase in the TAPSE in the study group when compared to the control group

Secondary Outcome Measures

Pulmonary vascular resistance
Left ventricular ejection fraction
Right ventricular myocardial performance index
Mechanical ventilation duration
Intensive care unit stay

Full Information

First Posted
January 2, 2017
Last Updated
June 1, 2017
Sponsor
Postgraduate Institute of Medical Education and Research
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1. Study Identification

Unique Protocol Identification Number
NCT03013075
Brief Title
General Plus Spinal Anesthesia and General Anesthesia Alone on Right Ventricular Function
Official Title
Comparative Effect of Combined High Spinal and General Anaesthesia With General Anaesthesia Alone On Right Ventricular Function In Patients With Mitral Valvular Disease With Pulmonary Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigator hypothesize that High Spinal Anesthesia (HSA) by its effect on attenuation of stress response, decrease in pulmonary vascular resistance, myocardial protection and positive myocardial oxygen balance will cause improvement in right ventricular function. So far there is no study that has evaluated the effect of HSA anesthesia on the right ventricular function, hence the investigator planned this study to compare the effect of HSA on the right ventricular function in patients with mitral valve disease with moderate to severe pulmonary hypertension planned for mitral valve replacement surgery.
Detailed Description
All study patients will undergo routine TTE and TEE examination protocol followed at the investigator institution. All the other routine monitoring such as end tidal carbon dioxide, urine output, ABG, ACT, BIS, electrolytes, blood sugar, hemoglobin and ventilatory parameters etc for open heart surgery will be done as per institutional practice. In the study group, the patients will receive spinal anesthesia after placement of invasive lines and prior to induction of GA.In both the study group GA will be induced with midazolam 1-2 mg, fentanyl 2μ/kg and propofol titrated to achieve loss of consciousness. Inj. Vecuronium bromide 0.1mg/kg will be used as muscle relaxant to facilitate tracheal intubation and lignocaine spray (LOX 10% spray, Neon laboratories LTD, Thane, India) will be used over vocal cords prior to intubation to blunt the sympathetic stimulation. Subsequently anesthesia will be maintained in both the groups, with isoflurane inhalation to maintain BIS values between 40 to 60. In control group, fentanyl infusion 1μ/kg/hr will be started for analgesia, a similar looking infusion without fentanyl will be started in the spinal group.All patients will be shifted to ICU with inotropic and vasopressor support as per the hemodynamic condition.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Right Ventricular Dysfunction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SPINAL PLUS GENERAL ANESTHESIA
Arm Type
Experimental
Arm Description
Patient will receive the intervention SPINAL ANESTHESIA before the start of surgery using Bupivacaine heavy 40 mg and Morphine 250 micro grams comprising a total volume of 8 ml to achieve a spinal block up to T2 level followed by general anesthesia
Arm Title
ONLY GENERAL ANESTHESIA
Arm Type
Active Comparator
Arm Description
Patient will receive only general anesthesia before the start of surgery
Intervention Type
Procedure
Intervention Name(s)
Spinal anesthesia with Bupivacaine heavy and Morphine
Intervention Description
Spinal anesthesia with Bupivacaine heavy 40 mg and Morphine 250 micro grams will be given to patient in addition to the routine general anesthesia before the start of surgery
Intervention Type
Drug
Intervention Name(s)
Bupivacaine heavy and Morphine
Intervention Type
Drug
Intervention Name(s)
General Anesthetics
Primary Outcome Measure Information:
Title
Improvement of right ventricular function defined by 20% increase in the TAPSE in the study group when compared to the control group
Time Frame
Till patient got discharged from ICU, an average of 5 days
Secondary Outcome Measure Information:
Title
Pulmonary vascular resistance
Time Frame
Till patient got discharged from ICU, an average of 5 days
Title
Left ventricular ejection fraction
Time Frame
Till patient got discharged from ICU, an average of 5 days
Title
Right ventricular myocardial performance index
Time Frame
Till patient got discharged from ICU, an average of 5 days
Title
Mechanical ventilation duration
Time Frame
Till patient got discharged from ICU, an average of 5 days
Title
Intensive care unit stay
Time Frame
Till patient got discharged from ICU, an average of 5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 50 consecutive patients of 18 to 60 years age, NYHA class II or III, with mitral valvular disease with moderate to severe PAH (mean pulmonary artery pressure > 40 mmHg) undergoing MVR Exclusion Criteria: emergency or redo surgery, patients with associated CAD or other valvular heart disease, COPD, bronchial asthma, obesity (BMI more than 30), anticipated difficult airway, opioid drug abuse or addiction and those with contraindication for spinal anaesthesia including local site infection, spinal deformity, deranged coagulogram defined by platelet count < 80,000 & INR > 1.
Facility Information:
Facility Name
PGIMER
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GANESH KUMAR M, MD
Phone
8968170779
Email
mganeshkumar19@gmail.com

12. IPD Sharing Statement

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General Plus Spinal Anesthesia and General Anesthesia Alone on Right Ventricular Function

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