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

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

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.

Study Overview

• Status: Unknown
• Conditions: Right Ventricular Dysfunction
• Intervention / Treatment: Procedure: Spinal anesthesia with Bupivacaine heavy and Morphine; Drug: Bupivacaine heavy and Morphine; Drug: General Anesthetics

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160012
    • Recruiting
    • PGIMER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SPINAL PLUS GENERAL ANESTHESIA; 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 Morphine; 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; Drug: Bupivacaine heavy and Morphine; Drug: General Anesthetics
ACTIVE_COMPARATOR: ONLY GENERAL ANESTHESIA; Patient will receive only general anesthesia before the start of surgery	Drug: General Anesthetics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (ANTICIPATED): December 1, 2017
• Study Completion (ANTICIPATED): December 1, 2017

Study Registration Dates

• First Submitted: January 2, 2017
• First Submitted That Met QC Criteria: January 5, 2017
• First Posted (ESTIMATE): January 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 5, 2017
• Last Update Submitted That Met QC Criteria: June 1, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction; Ventricular Dysfunction, Right; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Anesthetics, Local; Anesthetics; Bupivacaine; Morphine; Anesthetics, General
• Other Study ID Numbers: INT/IEC/2016/2573