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

Right Ventricular Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03013075
• Other study ID #: INT/IEC/2016/2573
• Status: Recruiting
• Phase: Phase 4
• First received: January 2, 2017
• Last updated: June 1, 2017
• Start date: November 2016
• Est. completion date: December 2017

Study information

• Verified date: June 2017
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Right Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Right

Intervention

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

• General Anesthetics

Locations

Country	Name	City	State
India	PGIMER	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pulmonary vascular resistance		Till patient got discharged from ICU, an average of 5 days
Secondary	Left ventricular ejection fraction		Till patient got discharged from ICU, an average of 5 days
Secondary	Right ventricular myocardial performance index		Till patient got discharged from ICU, an average of 5 days
Secondary	Mechanical ventilation duration		Till patient got discharged from ICU, an average of 5 days
Secondary	Intensive care unit stay		Till patient got discharged from ICU, an average of 5 days