NCT03013075

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 6, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

June 5, 2017

Status Verified

June 1, 2017

Enrollment Period

1.1 years

First QC Date

January 2, 2017

Last Update Submit

June 1, 2017

Conditions

Right Ventricular Dysfunction

Outcome Measures

Primary Outcomes (1)

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

    Till patient got discharged from ICU, an average of 5 days

Secondary Outcomes (5)

  • Pulmonary vascular resistance

    Till patient got discharged from ICU, an average of 5 days

  • Left ventricular ejection fraction

    Till patient got discharged from ICU, an average of 5 days

  • Right ventricular myocardial performance index

    Till patient got discharged from ICU, an average of 5 days

  • Mechanical ventilation duration

    Till patient got discharged from ICU, an average of 5 days

  • Intensive care unit stay

    Till patient got discharged from ICU, an average of 5 days

Study Arms (2)

SPINAL PLUS GENERAL ANESTHESIA

EXPERIMENTAL

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

Procedure: Spinal anesthesia with Bupivacaine heavy and MorphineDrug: Bupivacaine heavy and MorphineDrug: General Anesthetics

ONLY GENERAL ANESTHESIA

ACTIVE COMPARATOR

Patient will receive only general anesthesia before the start of surgery

Drug: General Anesthetics

Interventions

Spinal anesthesia with Bupivacaine heavy and MorphinePROCEDURE

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

SPINAL PLUS GENERAL ANESTHESIA
Bupivacaine heavy and MorphineDRUG
SPINAL PLUS GENERAL ANESTHESIA
General AnestheticsDRUG
ONLY GENERAL ANESTHESIASPINAL PLUS GENERAL ANESTHESIA

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PGIMER

Chandigarh, 160012, India

RECRUITING

MeSH Terms

Conditions

Ventricular Dysfunction, Right

Interventions

Anesthesia, SpinalMorphineAnesthetics, General

Condition Hierarchy (Ancestors)

Ventricular DysfunctionHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsAnestheticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCentral Nervous System AgentsTherapeutic Uses

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow resident, Department of anesthesia and intensive care

Study Record Dates

First Submitted

January 2, 2017

First Posted

January 6, 2017

Study Start

November 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

June 5, 2017

Record last verified: 2017-06

Locations

IN(1)