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

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Hypotension,Controlled

Intervention / Treatment
-----------------
* Drug: Nitroglycerin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged between 35 and 70 years Patients, undergoing canal decompression, intervertebral disc extraction and pedicle screw fixation (1 vertebral body) Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hypotension group (group H )<br>particcipants in hypotension group are received controlled hypertension in the operation. | Drug: Nitroglycerin<br>* 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.<br>* Other names: Controlled Hypotension;|
| No Intervention: control group (group C )<br>participants in cotrol group are received no controlled hypertension in the operation | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac index(CI) after the participants are taken into the operating room | CI(L/min/m^2) | during surgery | 
| cardiac index(CI) after the induction | cardiac index (CI,L/min/m^2) | during surgery | 
| cardiac index(CI) at 5 minutes after tubation | cardiac index (CI,L/min/m^2) | 5 minutes after tubation | 
| cardiac index(CI) at 10 minutes after tubation | cardiac index (CI,L/min/m^2). | 10 minutes after tubation | 
| cardiac index(CI) at 15 minutes after tubation | cardiac index (CI,L/min/m^2) | 15 minutes after tubation | 
| cardiac index(CI) at 30 minutes after tubation | cardiac index (CI,L/min/m^2) | 30 minutes after tubation | 
| cardiac index(CI) at 45 minutes after tubation | cardiac index (CI,L/min/m^2) | 45 minutes after tubation | 
| cardiac index(CI) at the end of surgery | cardiac index (CI,L/min/m^2). | at the end of surgery | 
| cardiac index(CI) at 1 minute after extubation | cardiac index (CI,L/min/m^2) | 1 minute after extubation | 
| cardiac index(CI) at 5 minutes after extubation | cardiac index (CI,L/min/m^2) | 5 minutes after extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial pressure of oxygen after the participants are taken into the operating room | Partial pressure of oxygen (PaO2,mmHg) | during surgery | 
| Arterial oxygen saturation after the participants are taken into the operating room | Arterial oxygen saturation (SaO2,%) | during surgery | 
| Arterial blood hemoglobin after the participants are taken into the operating room | Arterial blood hemoglobin (Hb,g/L) | during surgery | 
| Arterial blood lactate after the participants are taken into the operating room | Arterial blood lactate (Lac,mmol/L) | during surgery | 
| Partial pressure central venous oxygen after the participants are taken into the operating room | Partial pressure central venous oxygen(PvO2,mmHg) | during surgery | 
| Central venous blood oxygen saturation after the participants are taken into the operating room | Central venous blood oxygen saturation(ScvO2,%) | during surgery | 
| Oxygen supply index after the participants are taken into the operating room | Oxygen supply index (DO2I,ml/min/m^2) | during surgery | 
| Oxygen consumption index after the participants are taken into the operating room | Oxygen consumption index (VO2I,ml/min/m^2) | during surgery | 
| Partial pressure of oxygen after the induction | Partial pressure of oxygen (PaO2,mmHg) | during surgery | 
| Arterial oxygen saturation after the induction | Arterial oxygen saturation (SaO2,%) | during surgery | 
| Arterial blood hemoglobin after the induction | Arterial blood hemoglobin (Hb,g/L) | during surgery | 
| Arterial blood lactate after the induction | Arterial blood lactate (Lac,mmol/L) | during surgery | 
| Partial pressure central venous oxygen after the induction | Partial pressure central venous oxygen(PvO2,mmHg) | during surgery | 
| Central venous blood oxygen saturation after the induction | Central venous blood oxygen saturation(ScvO2,%) | during surgery | 
| Oxygen supply index after the induction | Oxygen supply index (DO2I,ml/min/m^2) | during surgery | 
| Oxygen consumption index after the induction | Oxygen consumption index (VO2I,ml/min/m^2) | during surgery | 
| Partial pressure of oxygen at 5 minutes after tubation | Partial pressure of oxygen (PaO2,mmHg) | 5 minutes after tubation | 
| Arterial oxygen saturation at 5 minutes after tubation | Arterial oxygen saturation (SaO2,%) | 5 minutes after tubation | 
| Arterial blood hemoglobin at 5 minutes after tubation | Arterial blood hemoglobin (Hb,g/L) | 5 minutes after tubation | 
| Arterial blood lactate at 5 minutes after tubation | Arterial blood lactate (Lac,mmol/L) | 5 minutes after tubation | 
| Partial pressure central venous oxygen at 5 minutes after tubation | Partial pressure central venous oxygen(PvO2,mmHg) | 5 minutes after tubation | 
| Central venous blood oxygen saturation at 5 minutes after tubation | Central venous blood oxygen saturation(ScvO2,%) | 5 minutes after tubation | 
| Oxygen supply index at 5 minutes after tubation | Oxygen supply index (DO2I,ml/min/m^2) | 5 minutes after tubation | 
| Oxygen consumption index at 5 minutes after tubation | Oxygen consumption index (VO2I,ml/min/m^2) | 5 minutes after tubation | 
| Partial pressure of oxygen at 10 minutes after tubation | Partial pressure of oxygen (PaO2,mmHg) | 10 minutes after tubation | 
| Arterial oxygen saturation at 10 minutes after tubation | Arterial oxygen saturation (SaO2,%) | 10 minutes after tubation | 
| Arterial blood hemoglobin at 10 minutes after tubation | Arterial blood hemoglobin (Hb,g/L) | 10 minutes after tubation | 
| Arterial blood lactate at 10 minutes after tubation | Arterial blood lactate (Lac,mmol/L) | 10 minutes after tubation | 
| Partial pressure central venous oxygen at 10 minutes after tubation | Partial pressure central venous oxygen(PvO2,mmHg) | 10 minutes after tubation | 
| Central venous blood oxygen saturation at 10 minutes after tubation | Central venous blood oxygen saturation(ScvO2,%) | 10 minutes after tubation | 
| Oxygen supply index at 10 minutes after tubation | Oxygen supply index (DO2I,ml/min/m^2) | 10 minutes after tubation | 
| Oxygen consumption index at 10 minutes after tubation | Oxygen consumption index (VO2I,ml/min/m^2) | 10 minutes after tubation | 
| Partial pressure of oxygen at 15 minutes after tubation | Partial pressure of oxygen (PaO2,mmHg) | 15 minutes after tubation | 
| Arterial oxygen saturation at 15 minutes after tubation | Arterial oxygen saturation (SaO2,%) | 15 minutes after tubation | 
| Arterial blood hemoglobin at 15 minutes after tubation | Arterial blood hemoglobin (Hb,g/L) | 15 minutes after tubation | 
| Arterial blood lactate at 15 minutes after tubation | Arterial blood lactate (Lac,mmol/L) | 15 minutes after tubation | 
| Partial pressure central venous oxygen at 15 minutes after tubation | Partial pressure central venous oxygen(PvO2,mmHg) | 15 minutes after tubation | 
| Central venous blood oxygen saturation at 15 minutes after tubation | Central venous blood oxygen saturation(ScvO2,%) | 15 minutes after tubation | 
| Oxygen supply index at 15 minutes after tubation | Oxygen supply index (DO2I,ml/min/m^2) | 15 minutes after tubation | 
| Calculated index at 15 minutes after tubation | Oxygen consumption index (VO2I,ml/min/m^2) | 15 minutes after tubation | 
| Partial pressure of oxygen at 30 minutes after tubation | Partial pressure of oxygen (PaO2,mmHg) | 30 minutes after tubation | 
| Arterial oxygen saturation at 30 minutes after tubation | Arterial oxygen saturation (SaO2,%) | 30 minutes after tubation | 
| Arterial blood hemoglobin at 30 minutes after tubation | Arterial blood hemoglobin (Hb,g/L) | 30 minutes after tubation | 
| Arterial blood lactate at 30 minutes after tubation | Arterial blood lactate (Lac,mmol/L) | 30 minutes after tubation | 
| Partial pressure central venous oxygen at 30 minutes after tubation | Partial pressure central venous oxygen(PvO2,mmHg) | 30 minutes after tubation | 
| Central venous blood oxygen saturation at 30 minutes after tubation | Central venous blood oxygen saturation(ScvO2,%) | 30 minutes after tubation | 
| Oxygen supply index at 30 minutes after tubation | Oxygen supply index (DO2I,ml/min/m^2) | 30 minutes after tubation | 
| Oxygen consumption index at 30 minutes after tubation | Oxygen consumption index (VO2I,ml/min/m^2) | 30 minutes after tubation | 
| Partial pressure of oxygen at 45 minutes after tubation | Partial pressure of oxygen (PaO2,mmHg) | 45 minutes after tubation | 
| Arterial oxygen saturation at 45 minutes after tubation | Arterial oxygen saturation (SaO2,%) | 45 minutes after tubation | 
| Arterial blood hemoglobin at 45 minutes after tubation | Arterial blood hemoglobin (Hb,g/L) | 45 minutes after tubation | 
| Partial pressure central venous oxygen at 45 minutes after tubation | Partial pressure central venous oxygen(PvO2,mmHg) | 45 minutes after tubation | 
| Arterial blood lactate at 45 minutes after tubation | Arterial blood lactate (Lac,mmol/L) | 45 minutes after tubation | 
| Oxygen supply index at 45 minutes after tubation | Oxygen supply index (DO2I,ml/min/m^2) | 45 minutes after tubation | 
| Oxygen consumption index at 45 minutes after tubation | Oxygen consumption index (VO2I,ml/min/m^2) | 45 minutes after tubation | 
| Central venous blood oxygen saturation at 45 minutes after tubation | Central venous blood oxygen saturation(ScvO2,%) | 45 minutes after tubation | 
| Partial pressure of oxygen at the end of surgery | Partial pressure of oxygen (PaO2,mmHg) | at the end of surgery | 
| Arterial oxygen saturation at the end of surgery | Arterial oxygen saturation (SaO2,%) | at the end of surgery | 
| Arterial blood hemoglobin at the end of surgery | Arterial blood hemoglobin (Hb,g/L) | at the end of surgery | 
| Arterial blood lactate at the end of surgery | Arterial blood lactate (Lac,mmol/L) | at the end of surgery | 
| Partial pressure central venous oxygen at the end of surgery | Partial pressure central venous oxygen(PvO2,mmHg) | at the end of surgery | 
| Central venous blood oxygen saturation at the end of surgery | Central venous blood oxygen saturation(ScvO2,%) | at the end of surgery | 
| Oxygen supply index at the end of surgery | Oxygen supply index (DO2I,ml/min/m^2) | at the end of surgery | 
| Oxygen consumption index at the end of surgery | Oxygen consumption index (VO2I,ml/min/m^2) | at the end of surgery | 
| Partial pressure of oxygen at 1 minute after extubation | Partial pressure of oxygen (PaO2,mmHg) | 1 minute after extubation | 
| Arterial oxygen saturation at 1 minute after extubation | Arterial oxygen saturation (SaO2,%) | 1 minute after extubation | 
| Arterial blood hemoglobin at 1 minute after extubation | Arterial blood hemoglobin (Hb,g/L) | 1 minute after extubation | 
| Arterial blood lactate at 1 minute after extubation | Arterial blood lactate (Lac,mmol/L) | 1 minute after extubation | 
| Partial pressure central venous oxygen at 1 minute after extubation | Partial pressure central venous oxygen(PvO2,mmHg) | 1 minute after extubation | 
| Central venous blood oxygen saturation at 1 minute after extubation | Central venous blood oxygen saturation(ScvO2,%) | 1 minute after extubation | 
| Oxygen supply index at 1 minute after extubation | Oxygen supply index (DO2I,ml/min/m^2) | 1 minute after extubation | 
| Oxygen consumption index at 1 minute after extubation | Oxygen consumption index (VO2I,ml/min/m^2) | 1 minute after extubation | 
| Plartia pressure of oxygen at 5 minutes after extubation | Plartia pressure of oxygen (PaO2,mmHg) | 5 minutes after extubation | 
| Arterial oxygen saturation at 5 minutes after extubation | Arterial oxygen saturation (SaO2,%) | 5 minutes after extubation | 
| Arterial blood hemoglobin at 5 minutes after extubation | Arterial blood hemoglobin (Hb,g/L) | 5 minutes after extubation | 
| Arterial blood lactate at 5 minutes after extubation | Arterial blood lactate (Lac,mmol/L) | 5 minutes after extubation | 
| Partial pressure central venous oxygen at 5 minutes after extubation | Partial pressure central venous oxnyge(PvO2,mmHg) | 5 minutes after extubation | 
| Central venous blood oxygen saturation at 5 minutes after extubation | Central venous blood oxygen saturation(ScvO2,%) | 5 minutes after extubation | 
| Oxygen supply index at 5 minutes after extubation | Oxygen supply index (DO2I,ml/min/m^2) | 5 minutes after extubation | 
| Oxygen consumption index at 5 minutes after extubation | Oxygen consumption index (VO2I,ml/min/m^2). | 5 minutes after extubation | 
| mean artery pressure(MAP) after the participants are taken into the operatin after the participantsg room | MAP(mmHg) | during surgery | 
| heart rate(HR) after the participants are taken into the operating room | HR(beat per minute) | during surgery | 
| central venous pressure(CVP) after the participants are taken into the operating room | CVP(mmHg) | during surgery | 
| variability of stroke volume(SVV) after the participants are taken into the operating room | SVV (%) | during surgery | 
| mean artery pressure(MAP) after the induction | MAP(mmHg) | during surgery | 
| heart rate(HR) after the induction | HR(heart rate,beat per minute) | during surgery | 
| central venous pressure(CVP) after the induction | CVP(mmHg) | during surgery | 
| variability of stroke volume(SVV) after the induction | SVV (variability of stroke volume,%) | during surgery | 
| mean artery pressure(MAP) at 5 minutes after tubation | MAP(mmHg)m^2) | 5 minutes after tubation | 
| heart rate(HR) at 5 minutes after tubation | HR(heart rate,beat per minute), | 5 minutes after tubation | 
| central venous pressure(CVP) at 5 minutes after tubation | CVP(mmHg) | 5 minutes after tubation | 
| variability of stroke volume(SVV) at 5 minutes after tubation | SVV (variability of stroke volume,%) | 5 minutes after tubation | 
| mean artery pressure(MAP) at 10 minutes after tubation | MAP(mmHg) | 10 minutes after tubation | 
| heart rate(HR) at 10 minutes after tubation | HR(heart rate,beat per minute) | 10 minutes after tubation | 
| central venous pressure(CVP) at 10 minutes after tubation | CVP(mmHg) | 10 minutes after tubation | 
| variability of stroke volume(SVV) at 10 minutes after tubation | SVV (variability of stroke volume,%) | 10 minutes after tubation | 
| mean artery pressure(MAP) at 15 minutes after tubation | MAP(mmHg) | 15 minutes after tubation | 
| heart rate(HR) at 15 minutes after tubation | HR(heart rate,beat per minute) | 15 minutes after tubation | 
| central venous pressure(CVP) at 15 minutes after tubation | CVP(mmHg) | 15 minutes after tubation | 
| variability of stroke volume(SVV) at 15 minutes after tubation | SVV (variability of stroke volume,%) | 15 minutes after tubation | 
| mean artery pressure(MAP) at 30 minutes after tubation | MAP(mmHg) | 30 minutes after tubation | 
| heart rate(HR) at 30 minutes after tubation | HR(heart rate,beat per minute) | 30 minutes after tubation | 
| central venous pressure(CVP) at 30 minutes after tubation | CVP(mmHg) | 30 minutes after tubation | 
| variability of stroke volume(SVV) at 30 minutes after tubation | SVV (variability of stroke volume,%) | 30 minutes after tubation | 
| mean artery pressure(MAP) at 45 minutes after tubation | MAP(mmHg) | 45 minutes after tubation | 
| heart rate(HR) at 45 minutes after tubation | HR(heart rate,beat per minute) | 45 minutes after tubation | 
| central venous pressure(CVP) at 45 minutes after tubation | CVP(mmHg) | 45 minutes after tubation | 
| variability of stroke volume(SVV) at 45 minutes after tubation | SVV (variability of stroke volume,%) | 45 minutes after tubation | 
| mean artery pressure(MAP) at the end of surgery | MAP(mmHg) | at the end of surgery | 
| central venous pressure(CVP) at the end of surgery | CVP(mmHg) | at the end of surgery | 
| variability of stroke volume(SVV) at the end of surgery | SVV (variability of stroke volume,%) | at the end of surgery | 
| heart rate(HR) at the end of surgery | HR(heart rate,beat per minute) | at the end of surgery | 
| mean artery pressure(MAP) at 1 minute after extubation | MAP(mmHg) | 1 minute after extubation | 
| heart rate(HR) at 1 minute after extubation | HR(heart rate,beat per minute) | 1 minute after extubation | 
| variability of stroke volume(SVV) at 1 minute after extubation | SVV (variability of stroke volume,%) | 1 minute after extubation | 
| central venous pressure(CVP) at 1 minute after extubation | CVP(mmHg) | 1 minute after extubation | 
| mean artery pressure(MAP) at 5 minutes after extubation | MAP(mmHg) | 5 minutes after extubation | 
| central venous pressure(CVP) at 5 minutes after extubation | CVP(mmHg) | 5 minutes after extubation | 
| heart rate(HR) at 5 minutes after extubation | HR(heart rate,beat per minute) | 5 minutes after extubation | 
| variability of stroke volume(SVV) at 5 minutes after extubation | SVV (variability of stroke volume,%) | 5 minutes after extubation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
controlled hypotension, cardiac output on, blood loss, surgical field, oxygen supply, oxygen consumption