Right Ventricular DysfunctionPhase 4NCT03013075
General Plus Spinal Anesthesia and General Anesthesia Alone on Right Ventricular Function
A Phase 4 study testing Spinal anesthesia with Bupivacaine heavy and Morphine, Bupivacaine heavy and Morphine and General Anesthetics in people with Right Ventricular Dysfunction, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Right Ventricular Dysfunction
- What is being tested?
- Spinal anesthesia with Bupivacaine heavy and Morphine, Bupivacaine heavy and Morphine and General Anesthetics
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2016to Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
PGIMER
Chandigarh, 160012
GANESH KUMAR M, MD, 8968170779, mganeshkumar19@gmail.com
About this study
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
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.
Read the 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
- Being tested
- Spinal anesthesia with Bupivacaine heavy and Morphine, Bupivacaine heavy and Morphine, General Anesthetics
- Medical subject headings
- Ventricular Dysfunction, Right
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anesthesia with Bupivacaine heavy and MorphineProcedure or surgery
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 MorphineDrug
General AnestheticsDrug
| Study group | Role | What they receive |
|---|---|---|
| SPINAL PLUS GENERAL ANESTHESIA | Experimental | 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 Receives: Procedure: Spinal anesthesia with Bupivacaine heavy and Morphine; Drug: Bupivacaine heavy and Morphine; Drug: General Anesthetics |
| ONLY GENERAL ANESTHESIA | Active comparator | Patient will receive only general anesthesia before the start of surgery Receives: Drug: General Anesthetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of right ventricular function defined by 20% increase in the TAPSE in the study group when compared to the control group
Measured: Till patient got discharged from ICU, an average of 5 days
Secondary outcomes (5)
Pulmonary vascular resistance
Measured: Till patient got discharged from ICU, an average of 5 days
Left ventricular ejection fraction
Measured: Till patient got discharged from ICU, an average of 5 days
Right ventricular myocardial performance index
Measured: Till patient got discharged from ICU, an average of 5 days
Mechanical ventilation duration
Measured: Till patient got discharged from ICU, an average of 5 days
Intensive care unit stay
Measured: Till patient got discharged from ICU, an average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startNov 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right Ventricular DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ganesh Kumar Munirathinam, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013075
- Sponsor's protocol ID
- INT/IEC/2016/2573
- Status last verified
- Jun 2017
- First submitted
- 2 Jan 2017
- Last updated
- 5 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03013075
- Acronym / sponsor ID
- INT/IEC/2016/2573
- Conditions
- Right Ventricular Dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 6 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPINAL PLUS GENERAL ANESTHESIA | Experimental | Procedure: Spinal anesthesia with Bupivacaine heavy and Morphine, Drug: Bupivacaine heavy and Morphine, Drug: General AnestheticsPatient 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 |
| ONLY GENERAL ANESTHESIA | Active comparator | Drug: General AnestheticsPatient will receive only general anesthesia before the start of surgery |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal anesthesia with Bupivacaine heavy and MorphineSpinal 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 | Procedure or surgery | SPINAL PLUS GENERAL ANESTHESIA |
| Bupivacaine heavy and Morphine | Drug | SPINAL PLUS GENERAL ANESTHESIA |
| General Anesthetics | Drug | ONLY GENERAL ANESTHESIA, SPINAL PLUS GENERAL ANESTHESIA |
Primary outcome
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
5 secondary outcomes
Pulmonary vascular resistance
Time frame: Till patient got discharged from ICU, an average of 5 days
Left ventricular ejection fraction
Time frame: Till patient got discharged from ICU, an average of 5 days
Right ventricular myocardial performance index
Time frame: Till patient got discharged from ICU, an average of 5 days
Mechanical ventilation duration
Time frame: Till patient got discharged from ICU, an average of 5 days
Intensive care unit stay
Time frame: Till patient got discharged from ICU, an average of 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Spinal anesthesia with Bupivacaine heavy and Morphine, Bupivacaine heavy and Morphine and General Anesthetics in people with Right Ventricular Dysfunction, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2017.