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

NCT ID: NCT03013075

Last Updated: 2017-06-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-12-31

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.

Conditions

Right Ventricular Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Spinal anesthesia with Bupivacaine heavy and Morphine

Intervention Type: PROCEDURE

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

Bupivacaine heavy and Morphine

Intervention Type: DRUG

General Anesthetics

Intervention Type: DRUG

ONLY GENERAL ANESTHESIA

Patient will receive only general anesthesia before the start of surgery

Group Type: ACTIVE_COMPARATOR

General Anesthetics

Intervention Type: DRUG

Interventions

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

Intervention Type: PROCEDURE

Bupivacaine heavy and Morphine

Intervention Type: DRUG

General Anesthetics

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role: lead

Responsible Party

Ganesh Kumar Munirathinam

Fellow resident, Department of anesthesia and intensive care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

PGIMER

Chandigarh, , India

Site Status: RECRUITING

Countries

India

Facility Contacts

GANESH KUMAR M, MD

Role: primary

mganeshkumar19@gmail.com

8968170779

Other Identifiers

INT/IEC/2016/2573

Identifier Type: -

Identifier Source: org_study_id