Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03013075
Recruitment Status : Unknown
Verified June 2017 by Ganesh Kumar Munirathinam, Postgraduate Institute of Medical Education and Research.
Recruitment status was:  Recruiting
First Posted : January 6, 2017
Last Update Posted : June 5, 2017
Sponsor:
Information provided by (Responsible Party):
Ganesh Kumar Munirathinam, Postgraduate Institute of Medical Education and Research

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.

Condition or disease Intervention/treatment Phase
Right Ventricular Dysfunction Procedure: Spinal anesthesia with Bupivacaine heavy and Morphine Drug: Bupivacaine heavy and Morphine Drug: General Anesthetics Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Study Start Date : November 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Bupivacaine

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



Primary Outcome Measures :
  1. Improvement of right ventricular function defined by 20% increase in the TAPSE in the study group when compared to the control group [ Time Frame: Till patient got discharged from ICU, an average of 5 days ]

Secondary Outcome Measures :
  1. Pulmonary vascular resistance [ Time Frame: Till patient got discharged from ICU, an average of 5 days ]
  2. Left ventricular ejection fraction [ Time Frame: Till patient got discharged from ICU, an average of 5 days ]
  3. Right ventricular myocardial performance index [ Time Frame: Till patient got discharged from ICU, an average of 5 days ]
  4. Mechanical ventilation duration [ Time Frame: Till patient got discharged from ICU, an average of 5 days ]
  5. Intensive care unit stay [ Time Frame: Till patient got discharged from ICU, an average of 5 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03013075


Locations
Layout table for location information
India
PGIMER Recruiting
Chandigarh, India, 160012
Contact: GANESH KUMAR M, MD    8968170779    mganeshkumar19@gmail.com   
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research

Layout table for additonal information
Responsible Party: Ganesh Kumar Munirathinam, Fellow resident, Department of anesthesia and intensive care, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT03013075    
Other Study ID Numbers: INT/IEC/2016/2573
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: June 5, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Ventricular Dysfunction
Ventricular Dysfunction, Right
Heart Diseases
Cardiovascular Diseases
Morphine
Anesthetics
Bupivacaine
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics