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Hypotension,ControlledNCT03917004

Correlation Analysis of the Effects of Management Pressure Goals and Control Volume Goals in Patients in Spinal Surgery

A study testing Nitroglycerin in people with Hypotension,Controlled, run by Liang Bing at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The investigators study 160 patients undergoing spinal surgery.Participants will be randomly divided into study group and control group.The study group will receive controlled hypotension by nitroglycerin and be divided into 3 groups according to CI. Read more about this study

Who is it for?
Ages 35 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Hypotension,Controlled
What is being tested?
Nitroglycerin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteChina
Study dates
1 Apr 2019to 30 Sep 2019
Phase
Interventional
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 35 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Aged between 35 and 70 years
  • Patients, undergoing canal decompression, intervertebral disc extraction and pedicle screw fixation (1 vertebral body)

Who cannot join

  • History of cardiovascular function
  • congestive heart failure [CHF]
  • coronary artery disease [CAD]
  • cerebrovascular insuffiency)
  • poorly controlled arterial hypertension
  • pre-existing coagulation defects
  • Patients taking anticoagulatory medication including aspirin
  • Patients taking corticosteroid therapy

Trial locations and contacts

1 site in 1 country.

Cao Yang contact

+86-020-34403854

caoy2008@163.com

Yang contact

China1 site, 1 recruiting

  • Guangzhou Red cross hospital

    Guangzhou, Guangdong, 510220

    Liang Bing, 020-34403854, 27291375@qq.com

    Recruiting

Other trials in China

About this study

Official title: Correlation Analysis of the Effects of Management Pressure Goals (Controlled Hypotension) and Control Volume Goals (Cardiac Output, Stroke Volume Variability, Central Venous Pressure) on Intraoperative Blood and Visual Field Quality

The investigators study 160 patients undergoing spinal surgery.Participants will be randomly divided into study group and control group.The study group will receive controlled hypotension by nitroglycerin and be divided into 3 groups according to CI.

Read the detailed description

This study will be done in Guangzhou Red Cross Hospital .The investigators study 160 patients aged from 45 to 70 years,weight from 48 to 68kg classified as American Society of Anesthesiologists (ASAs) physical status Ⅰ-Ⅱ who will be candidate for posterior decompression of vertebral canal,discectomy and internal fixation by pediclescrew(one centrum).The investigators excluded patients with cardiovascular and cerebrovascular diseases,hepatic or renal dysfunction,and patients receiving drugs that interfere with coagulation before surgery.

Patients randomly divided into study group(group H,n=120)and control group (group C,n=40).The study group according to CI(Cardiac Index) levels of intraoperative hypotension period(mean of CI at T2,T3,T4) were divided into three groups: 1st group: CI: 1.5-2.0 L /(min•m2), 2nd group: CI: 2.0-3.0 L /(min•m2), 3rd group: CI: 3.0-4.0 L /(min•m2),and which CI < 1.5 or CI > 4.0 was eliminated the experimental group, which, in control group, CI< 2.5 or CI >4.0 was eliminated the experimental group.

Being tested
Nitroglycerin
Keywords
controlled hypotension, cardiac output on, blood loss, surgical field, oxygen supply, oxygen consumption
Medical subject headings
Hypotension, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NitroglycerinDrug

    Also called Controlled Hypotension

    The starting rate of "nitroglycerin" was 0.25 μg / kg / min and the mean arterial pressure (MAP) decreased to 80% of the baseline but not less than 70%.The drug infusion rate was adjusted so that the MAP was maintained in the range to the suture, and the administration was stopped and the blood pressure was gradually returned to the pre-depressurization level.

Study groups in NCT03917004
Study groupRoleWhat they receive
hypotension group (group H )Experimentalparticcipants in hypotension group are received controlled hypertension in the operation.
Receives: Drug: Nitroglycerin
control group (group C )No interventionparticipants in cotrol group are received no controlled hypertension in the operation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cardiac index(CI) after the participants are taken into the operating room

    CI(L/min/m^2)

    Measured: during surgery

  2. cardiac index(CI) after the induction

    cardiac index (CI,L/min/m^2)

    Measured: during surgery

  3. cardiac index(CI) at 5 minutes after tubation

    cardiac index (CI,L/min/m^2)

    Measured: 5 minutes after tubation

  4. cardiac index(CI) at 10 minutes after tubation

    cardiac index (CI,L/min/m^2).

    Measured: 10 minutes after tubation

  5. cardiac index(CI) at 15 minutes after tubation

    cardiac index (CI,L/min/m^2)

    Measured: 15 minutes after tubation

  6. cardiac index(CI) at 30 minutes after tubation

    cardiac index (CI,L/min/m^2)

    Measured: 30 minutes after tubation

  7. cardiac index(CI) at 45 minutes after tubation

    cardiac index (CI,L/min/m^2)

    Measured: 45 minutes after tubation

  8. cardiac index(CI) at the end of surgery

    cardiac index (CI,L/min/m^2).

    Measured: at the end of surgery

  9. cardiac index(CI) at 1 minute after extubation

    cardiac index (CI,L/min/m^2)

    Measured: 1 minute after extubation

  10. cardiac index(CI) at 5 minutes after extubation

    cardiac index (CI,L/min/m^2)

    Measured: 5 minutes after extubation

Secondary outcomes (120)

  1. Partial pressure of oxygen after the participants are taken into the operating room

    Partial pressure of oxygen (PaO2,mmHg)

    Measured: during surgery

  2. Arterial oxygen saturation after the participants are taken into the operating room

    Arterial oxygen saturation (SaO2,%)

    Measured: during surgery

  3. Arterial blood hemoglobin after the participants are taken into the operating room

    Arterial blood hemoglobin (Hb,g/L)

    Measured: during surgery

  4. Arterial blood lactate after the participants are taken into the operating room

    Arterial blood lactate (Lac,mmol/L)

    Measured: during surgery

  5. Partial pressure central venous oxygen after the participants are taken into the operating room

    Partial pressure central venous oxygen(PvO2,mmHg)

    Measured: during surgery

  6. Central venous blood oxygen saturation after the participants are taken into the operating room

    Central venous blood oxygen saturation(ScvO2,%)

    Measured: during surgery

  7. Oxygen supply index after the participants are taken into the operating room

    Oxygen supply index (DO2I,ml/min/m^2)

    Measured: during surgery

  8. Oxygen consumption index after the participants are taken into the operating room

    Oxygen consumption index (VO2I,ml/min/m^2)

    Measured: during surgery

  9. Partial pressure of oxygen after the induction

    Partial pressure of oxygen (PaO2,mmHg)

    Measured: during surgery

  10. Arterial oxygen saturation after the induction

    Arterial oxygen saturation (SaO2,%)

    Measured: during surgery

  11. Arterial blood hemoglobin after the induction

    Arterial blood hemoglobin (Hb,g/L)

    Measured: during surgery

  12. Arterial blood lactate after the induction

    Arterial blood lactate (Lac,mmol/L)

    Measured: during surgery

  13. Partial pressure central venous oxygen after the induction

    Partial pressure central venous oxygen(PvO2,mmHg)

    Measured: during surgery

  14. Central venous blood oxygen saturation after the induction

    Central venous blood oxygen saturation(ScvO2,%)

    Measured: during surgery

  15. Oxygen supply index after the induction

    Oxygen supply index (DO2I,ml/min/m^2)

    Measured: during surgery

  16. Oxygen consumption index after the induction

    Oxygen consumption index (VO2I,ml/min/m^2)

    Measured: during surgery

  17. Partial pressure of oxygen at 5 minutes after tubation

    Partial pressure of oxygen (PaO2,mmHg)

    Measured: 5 minutes after tubation

  18. Arterial oxygen saturation at 5 minutes after tubation

    Arterial oxygen saturation (SaO2,%)

    Measured: 5 minutes after tubation

  19. Arterial blood hemoglobin at 5 minutes after tubation

    Arterial blood hemoglobin (Hb,g/L)

    Measured: 5 minutes after tubation

  20. Arterial blood lactate at 5 minutes after tubation

    Arterial blood lactate (Lac,mmol/L)

    Measured: 5 minutes after tubation

  21. Partial pressure central venous oxygen at 5 minutes after tubation

    Partial pressure central venous oxygen(PvO2,mmHg)

    Measured: 5 minutes after tubation

  22. Central venous blood oxygen saturation at 5 minutes after tubation

    Central venous blood oxygen saturation(ScvO2,%)

    Measured: 5 minutes after tubation

  23. Oxygen supply index at 5 minutes after tubation

    Oxygen supply index (DO2I,ml/min/m^2)

    Measured: 5 minutes after tubation

  24. Oxygen consumption index at 5 minutes after tubation

    Oxygen consumption index (VO2I,ml/min/m^2)

    Measured: 5 minutes after tubation

  25. Partial pressure of oxygen at 10 minutes after tubation

    Partial pressure of oxygen (PaO2,mmHg)

    Measured: 10 minutes after tubation

  26. Arterial oxygen saturation at 10 minutes after tubation

    Arterial oxygen saturation (SaO2,%)

    Measured: 10 minutes after tubation

  27. Arterial blood hemoglobin at 10 minutes after tubation

    Arterial blood hemoglobin (Hb,g/L)

    Measured: 10 minutes after tubation

  28. Arterial blood lactate at 10 minutes after tubation

    Arterial blood lactate (Lac,mmol/L)

    Measured: 10 minutes after tubation

  29. Partial pressure central venous oxygen at 10 minutes after tubation

    Partial pressure central venous oxygen(PvO2,mmHg)

    Measured: 10 minutes after tubation

  30. Central venous blood oxygen saturation at 10 minutes after tubation

    Central venous blood oxygen saturation(ScvO2,%)

    Measured: 10 minutes after tubation

  31. Oxygen supply index at 10 minutes after tubation

    Oxygen supply index (DO2I,ml/min/m^2)

    Measured: 10 minutes after tubation

  32. Oxygen consumption index at 10 minutes after tubation

    Oxygen consumption index (VO2I,ml/min/m^2)

    Measured: 10 minutes after tubation

  33. Partial pressure of oxygen at 15 minutes after tubation

    Partial pressure of oxygen (PaO2,mmHg)

    Measured: 15 minutes after tubation

  34. Arterial oxygen saturation at 15 minutes after tubation

    Arterial oxygen saturation (SaO2,%)

    Measured: 15 minutes after tubation

  35. Arterial blood hemoglobin at 15 minutes after tubation

    Arterial blood hemoglobin (Hb,g/L)

    Measured: 15 minutes after tubation

  36. Arterial blood lactate at 15 minutes after tubation

    Arterial blood lactate (Lac,mmol/L)

    Measured: 15 minutes after tubation

  37. Partial pressure central venous oxygen at 15 minutes after tubation

    Partial pressure central venous oxygen(PvO2,mmHg)

    Measured: 15 minutes after tubation

  38. Central venous blood oxygen saturation at 15 minutes after tubation

    Central venous blood oxygen saturation(ScvO2,%)

    Measured: 15 minutes after tubation

  39. Oxygen supply index at 15 minutes after tubation

    Oxygen supply index (DO2I,ml/min/m^2)

    Measured: 15 minutes after tubation

  40. Calculated index at 15 minutes after tubation

    Oxygen consumption index (VO2I,ml/min/m^2)

    Measured: 15 minutes after tubation

  41. Partial pressure of oxygen at 30 minutes after tubation

    Partial pressure of oxygen (PaO2,mmHg)

    Measured: 30 minutes after tubation

  42. Arterial oxygen saturation at 30 minutes after tubation

    Arterial oxygen saturation (SaO2,%)

    Measured: 30 minutes after tubation

  43. Arterial blood hemoglobin at 30 minutes after tubation

    Arterial blood hemoglobin (Hb,g/L)

    Measured: 30 minutes after tubation

  44. Arterial blood lactate at 30 minutes after tubation

    Arterial blood lactate (Lac,mmol/L)

    Measured: 30 minutes after tubation

  45. Partial pressure central venous oxygen at 30 minutes after tubation

    Partial pressure central venous oxygen(PvO2,mmHg)

    Measured: 30 minutes after tubation

  46. Central venous blood oxygen saturation at 30 minutes after tubation

    Central venous blood oxygen saturation(ScvO2,%)

    Measured: 30 minutes after tubation

  47. Oxygen supply index at 30 minutes after tubation

    Oxygen supply index (DO2I,ml/min/m^2)

    Measured: 30 minutes after tubation

  48. Oxygen consumption index at 30 minutes after tubation

    Oxygen consumption index (VO2I,ml/min/m^2)

    Measured: 30 minutes after tubation

  49. Partial pressure of oxygen at 45 minutes after tubation

    Partial pressure of oxygen (PaO2,mmHg)

    Measured: 45 minutes after tubation

  50. Arterial oxygen saturation at 45 minutes after tubation

    Arterial oxygen saturation (SaO2,%)

    Measured: 45 minutes after tubation

  51. Arterial blood hemoglobin at 45 minutes after tubation

    Arterial blood hemoglobin (Hb,g/L)

    Measured: 45 minutes after tubation

  52. Partial pressure central venous oxygen at 45 minutes after tubation

    Partial pressure central venous oxygen(PvO2,mmHg)

    Measured: 45 minutes after tubation

  53. Arterial blood lactate at 45 minutes after tubation

    Arterial blood lactate (Lac,mmol/L)

    Measured: 45 minutes after tubation

  54. Oxygen supply index at 45 minutes after tubation

    Oxygen supply index (DO2I,ml/min/m^2)

    Measured: 45 minutes after tubation

  55. Oxygen consumption index at 45 minutes after tubation

    Oxygen consumption index (VO2I,ml/min/m^2)

    Measured: 45 minutes after tubation

  56. Central venous blood oxygen saturation at 45 minutes after tubation

    Central venous blood oxygen saturation(ScvO2,%)

    Measured: 45 minutes after tubation

  57. Partial pressure of oxygen at the end of surgery

    Partial pressure of oxygen (PaO2,mmHg)

    Measured: at the end of surgery

  58. Arterial oxygen saturation at the end of surgery

    Arterial oxygen saturation (SaO2,%)

    Measured: at the end of surgery

  59. Arterial blood hemoglobin at the end of surgery

    Arterial blood hemoglobin (Hb,g/L)

    Measured: at the end of surgery

  60. Arterial blood lactate at the end of surgery

    Arterial blood lactate (Lac,mmol/L)

    Measured: at the end of surgery

  61. Partial pressure central venous oxygen at the end of surgery

    Partial pressure central venous oxygen(PvO2,mmHg)

    Measured: at the end of surgery

  62. Central venous blood oxygen saturation at the end of surgery

    Central venous blood oxygen saturation(ScvO2,%)

    Measured: at the end of surgery

  63. Oxygen supply index at the end of surgery

    Oxygen supply index (DO2I,ml/min/m^2)

    Measured: at the end of surgery

  64. Oxygen consumption index at the end of surgery

    Oxygen consumption index (VO2I,ml/min/m^2)

    Measured: at the end of surgery

  65. Partial pressure of oxygen at 1 minute after extubation

    Partial pressure of oxygen (PaO2,mmHg)

    Measured: 1 minute after extubation

  66. Arterial oxygen saturation at 1 minute after extubation

    Arterial oxygen saturation (SaO2,%)

    Measured: 1 minute after extubation

  67. Arterial blood hemoglobin at 1 minute after extubation

    Arterial blood hemoglobin (Hb,g/L)

    Measured: 1 minute after extubation

  68. Arterial blood lactate at 1 minute after extubation

    Arterial blood lactate (Lac,mmol/L)

    Measured: 1 minute after extubation

  69. Partial pressure central venous oxygen at 1 minute after extubation

    Partial pressure central venous oxygen(PvO2,mmHg)

    Measured: 1 minute after extubation

  70. Central venous blood oxygen saturation at 1 minute after extubation

    Central venous blood oxygen saturation(ScvO2,%)

    Measured: 1 minute after extubation

  71. Oxygen supply index at 1 minute after extubation

    Oxygen supply index (DO2I,ml/min/m^2)

    Measured: 1 minute after extubation

  72. Oxygen consumption index at 1 minute after extubation

    Oxygen consumption index (VO2I,ml/min/m^2)

    Measured: 1 minute after extubation

  73. Plartia pressure of oxygen at 5 minutes after extubation

    Plartia pressure of oxygen (PaO2,mmHg)

    Measured: 5 minutes after extubation

  74. Arterial oxygen saturation at 5 minutes after extubation

    Arterial oxygen saturation (SaO2,%)

    Measured: 5 minutes after extubation

  75. Arterial blood hemoglobin at 5 minutes after extubation

    Arterial blood hemoglobin (Hb,g/L)

    Measured: 5 minutes after extubation

  76. Arterial blood lactate at 5 minutes after extubation

    Arterial blood lactate (Lac,mmol/L)

    Measured: 5 minutes after extubation

  77. Partial pressure central venous oxygen at 5 minutes after extubation

    Partial pressure central venous oxnyge(PvO2,mmHg)

    Measured: 5 minutes after extubation

  78. Central venous blood oxygen saturation at 5 minutes after extubation

    Central venous blood oxygen saturation(ScvO2,%)

    Measured: 5 minutes after extubation

  79. Oxygen supply index at 5 minutes after extubation

    Oxygen supply index (DO2I,ml/min/m^2)

    Measured: 5 minutes after extubation

  80. Oxygen consumption index at 5 minutes after extubation

    Oxygen consumption index (VO2I,ml/min/m^2).

    Measured: 5 minutes after extubation

  81. mean artery pressure(MAP) after the participants are taken into the operatin after the participantsg room

    MAP(mmHg)

    Measured: during surgery

  82. heart rate(HR) after the participants are taken into the operating room

    HR(beat per minute)

    Measured: during surgery

  83. central venous pressure(CVP) after the participants are taken into the operating room

    CVP(mmHg)

    Measured: during surgery

  84. variability of stroke volume(SVV) after the participants are taken into the operating room

    SVV (%)

    Measured: during surgery

  85. mean artery pressure(MAP) after the induction

    MAP(mmHg)

    Measured: during surgery

  86. heart rate(HR) after the induction

    HR(heart rate,beat per minute)

    Measured: during surgery

  87. central venous pressure(CVP) after the induction

    CVP(mmHg)

    Measured: during surgery

  88. variability of stroke volume(SVV) after the induction

    SVV (variability of stroke volume,%)

    Measured: during surgery

  89. mean artery pressure(MAP) at 5 minutes after tubation

    MAP(mmHg)m^2)

    Measured: 5 minutes after tubation

  90. heart rate(HR) at 5 minutes after tubation

    HR(heart rate,beat per minute),

    Measured: 5 minutes after tubation

  91. central venous pressure(CVP) at 5 minutes after tubation

    CVP(mmHg)

    Measured: 5 minutes after tubation

  92. variability of stroke volume(SVV) at 5 minutes after tubation

    SVV (variability of stroke volume,%)

    Measured: 5 minutes after tubation

  93. mean artery pressure(MAP) at 10 minutes after tubation

    MAP(mmHg)

    Measured: 10 minutes after tubation

  94. heart rate(HR) at 10 minutes after tubation

    HR(heart rate,beat per minute)

    Measured: 10 minutes after tubation

  95. central venous pressure(CVP) at 10 minutes after tubation

    CVP(mmHg)

    Measured: 10 minutes after tubation

  96. variability of stroke volume(SVV) at 10 minutes after tubation

    SVV (variability of stroke volume,%)

    Measured: 10 minutes after tubation

  97. mean artery pressure(MAP) at 15 minutes after tubation

    MAP(mmHg)

    Measured: 15 minutes after tubation

  98. heart rate(HR) at 15 minutes after tubation

    HR(heart rate,beat per minute)

    Measured: 15 minutes after tubation

  99. central venous pressure(CVP) at 15 minutes after tubation

    CVP(mmHg)

    Measured: 15 minutes after tubation

  100. variability of stroke volume(SVV) at 15 minutes after tubation

    SVV (variability of stroke volume,%)

    Measured: 15 minutes after tubation

  101. mean artery pressure(MAP) at 30 minutes after tubation

    MAP(mmHg)

    Measured: 30 minutes after tubation

  102. heart rate(HR) at 30 minutes after tubation

    HR(heart rate,beat per minute)

    Measured: 30 minutes after tubation

  103. central venous pressure(CVP) at 30 minutes after tubation

    CVP(mmHg)

    Measured: 30 minutes after tubation

  104. variability of stroke volume(SVV) at 30 minutes after tubation

    SVV (variability of stroke volume,%)

    Measured: 30 minutes after tubation

  105. mean artery pressure(MAP) at 45 minutes after tubation

    MAP(mmHg)

    Measured: 45 minutes after tubation

  106. heart rate(HR) at 45 minutes after tubation

    HR(heart rate,beat per minute)

    Measured: 45 minutes after tubation

  107. central venous pressure(CVP) at 45 minutes after tubation

    CVP(mmHg)

    Measured: 45 minutes after tubation

  108. variability of stroke volume(SVV) at 45 minutes after tubation

    SVV (variability of stroke volume,%)

    Measured: 45 minutes after tubation

  109. mean artery pressure(MAP) at the end of surgery

    MAP(mmHg)

    Measured: at the end of surgery

  110. central venous pressure(CVP) at the end of surgery

    CVP(mmHg)

    Measured: at the end of surgery

  111. variability of stroke volume(SVV) at the end of surgery

    SVV (variability of stroke volume,%)

    Measured: at the end of surgery

  112. heart rate(HR) at the end of surgery

    HR(heart rate,beat per minute)

    Measured: at the end of surgery

  113. mean artery pressure(MAP) at 1 minute after extubation

    MAP(mmHg)

    Measured: 1 minute after extubation

  114. heart rate(HR) at 1 minute after extubation

    HR(heart rate,beat per minute)

    Measured: 1 minute after extubation

  115. variability of stroke volume(SVV) at 1 minute after extubation

    SVV (variability of stroke volume,%)

    Measured: 1 minute after extubation

  116. central venous pressure(CVP) at 1 minute after extubation

    CVP(mmHg)

    Measured: 1 minute after extubation

  117. mean artery pressure(MAP) at 5 minutes after extubation

    MAP(mmHg)

    Measured: 5 minutes after extubation

  118. central venous pressure(CVP) at 5 minutes after extubation

    CVP(mmHg)

    Measured: 5 minutes after extubation

  119. heart rate(HR) at 5 minutes after extubation

    HR(heart rate,beat per minute)

    Measured: 5 minutes after extubation

  120. variability of stroke volume(SVV) at 5 minutes after extubation

    SVV (variability of stroke volume,%)

    Measured: 5 minutes after extubation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2019
  2. Study start1 Apr 2019
  3. Primary completion30 Sep 2019 (estimated)
  4. Study completion30 Sep 2019 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03917004
Sponsor's protocol ID
2018-032-01
Status last verified
Apr 2019
First submitted
5 Mar 2019
Last updated
16 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kako H, Gable A, Martin D, Beebe A, Thung A, Samora W, Klamar J, Bhalla T, Tobias JD. A prospective, open-label trial of clevidipine for controlled hypotension during posterior spinal fusion. J Pediatr Pharmacol Ther. 2015 Jan-Feb;20(1):54-60. doi: 10.5863/1551-6776-20.1.54.

    PubMed 25859171

  • Amr YM, Amin SM. Effects of preoperative beta-blocker on blood loss and blood transfusion during spinal surgeries with sodium nitroprusside-controlled hypotension. Saudi J Anaesth. 2012 Jul;6(3):263-7. doi: 10.4103/1658-354X.101219.

    PubMed 23162401

Questions about this trial

What is this clinical trial studying?

A study testing Nitroglycerin in people with Hypotension,Controlled, run by Liang Bing at 1 site in China.

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 2 inclusion and 8 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 16 Apr 2019. 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 China. 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.

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?

Contact Cao Yang (+86-020-34403854, caoy2008@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cardiac index(CI) after the participants are taken into the operating room (time frame: during surgery). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03917004, which also lists 2 linked publications.

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 16 Apr 2019.

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