NCT03013075

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Right Ventricular Dysfunction

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2017-01-06
• Last updated: 2017-06-05

Locations

1 site across 1 country: India