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

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.

Study Overview

• Status: Unknown
• Conditions: Hypotension,Controlled
• Intervention / Treatment: Drug: Nitroglycerin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510220
      • Recruiting
      • Guangzhou Red Cross Hospital
      • Contact: Liang Bing; Phone Number: 020-34403854; Email: 27291375@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. History of cardiovascular function

   1. congestive heart failure [CHF]
   2. coronary artery disease [CAD]
   3. cerebrovascular insuffiency)
2. poorly controlled arterial hypertension
3. pre-existing coagulation defects
4. Patients taking anticoagulatory medication including aspirin
5. Patients taking corticosteroid therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hypotension group (group H ); particcipants in hypotension group are received controlled hypertension in the operation.	Drug: Nitroglycerin; 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.; Other Names: Controlled Hypotension
No Intervention: control group (group C ); 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scores of surgical field quality after the induction	Scores of surgical field quality by Fromme et al. and Boezzart et al.(Score 5 means massive uncontrollable bleeding.Score 4 means heavy but controllable bleeding, significant interference with dissection.Score 3 means moderate bleeding,modest compromise of the surgical field. Score 2 means moderate bleeding,nuisance in regard to the surgical field ,but no actual compromise of the ability to dissect.Score 1 means mild bleeding,but no interference with dissection.Score 0 means minimal bleeding,very dry field).	during surgery
Scores of surgical field quality at 5 minutes after tubation	Scores of surgical field quality by Fromme et al. and Boezzart et al.(Score 5 means massive uncontrollable bleeding.Score 4 means heavy but controllable bleeding, significant interference with dissection.Score 3 means moderate bleeding,modest compromise of the surgical field. Score 2 means moderate bleeding,nuisance in regard to the surgical field ,but no actual compromise of the ability to dissect.Score 1 means mild bleeding,but no interference with dissection.Score 0 means minimal bleeding,very dry field).	5 minutes after tubation
Scores of surgical field quality at 10 minutes after tubation	Scores of surgical field quality by Fromme et al. and Boezzart et al.(Score 5 means massive uncontrollable bleeding.Score 4 means heavy but controllable bleeding, significant interference with dissection.Score 3 means moderate bleeding,modest compromise of the surgical field. Score 2 means moderate bleeding,nuisance in regard to the surgical field ,but no actual compromise of the ability to dissect.Score 1 means mild bleeding,but no interference with dissection.Score 0 means minimal bleeding,very dry field).	10 minutes after tubation
Scores of surgical field quality at 15 minutes after tubation	Scores of surgical field quality by Fromme et al. and Boezzart et al.(Score 5 means massive uncontrollable bleeding.Score 4 means heavy but controllable bleeding, significant interference with dissection.Score 3 means moderate bleeding,modest compromise of the surgical field. Score 2 means moderate bleeding,nuisance in regard to the surgical field ,but no actual compromise of the ability to dissect.Score 1 means mild bleeding,but no interference with dissection.Score 0 means minimal bleeding,very dry field).	15 minutes after tubation
Scores of surgical field quality at 30 minutes after tubation	Scores of surgical field quality by Fromme et al. and Boezzart et al.(Score 5 means massive uncontrollable bleeding.Score 4 means heavy but controllable bleeding, significant interference with dissection.Score 3 means moderate bleeding,modest compromise of the surgical field. Score 2 means moderate bleeding,nuisance in regard to the surgical field ,but no actual compromise of the ability to dissect.Score 1 means mild bleeding,but no interference with dissection.Score 0 means minimal bleeding,very dry field).	30 minutes after tubation
Scores of surgical field quality at 45 minutes after tubation	Scores of surgical field quality by Fromme et al. and Boezzart et al.(Score 5 means massive uncontrollable bleeding.Score 4 means heavy but controllable bleeding, significant interference with dissection.Score 3 means moderate bleeding,modest compromise of the surgical field. Score 2 means moderate bleeding,nuisance in regard to the surgical field ,but no actual compromise of the ability to dissect.Score 1 means mild bleeding,but no interference with dissection.Score 0 means minimal bleeding,very dry field).	45 minutes after tubation
Scores of surgical field quality at the end of surgery	Scores of surgical field quality by Fromme et al. and Boezzart et al.(Score 5 means massive uncontrollable bleeding.Score 4 means heavy but controllable bleeding, significant interference with dissection.Score 3 means moderate bleeding,modest compromise of the surgical field. Score 2 means moderate bleeding,nuisance in regard to the surgical field ,but no actual compromise of the ability to dissect.Score 1 means mild bleeding,but no interference with dissection.Score 0 means minimal bleeding,very dry field).	at the end of surgery
Scores of surgical field quality at 5 minutes after extubation	Scores of surgical field quality by Fromme et al. and Boezzart et al.(Score 5 means massive uncontrollable bleeding.Score 4 means heavy but controllable bleeding, significant interference with dissection.Score 3 means moderate bleeding,modest compromise of the surgical field. Score 2 means moderate bleeding,nuisance in regard to the surgical field ,but no actual compromise of the ability to dissect.Score 1 means mild bleeding,but no interference with dissection.Score 0 means minimal bleeding,very dry field).	5 minutes after extubation
Scores of surgical field quality at 1 minute after extubation	Scores of surgical field quality by Fromme et al. and Boezzart et al.(Score 5 means massive uncontrollable bleeding.Score 4 means heavy but controllable bleeding, significant interference with dissection.Score 3 means moderate bleeding,modest compromise of the surgical field. Score 2 means moderate bleeding,nuisance in regard to the surgical field ,but no actual compromise of the ability to dissect.Score 1 means mild bleeding,but no interference with dissection.Score 0 means minimal bleeding,very dry field).	1 minute after extubation
operation time after the induction	operation time（minutes）	during surgery
operation time after the participants are taken into the operating room	operation time（minutes）	during surgery
operation time at 5 minutes after tubation	operation time（minutes）	5 minutes after tubation
operation time at 10 minutes after tubation	operation time（minutes）	10 minutes after tubation
operation time at 15 minutes after tubation	operation time（minutes）	15 minutes after tubation
operation time at 30 minutes after tubation	operation time（minutes）	30 minutes after tubation
operation time at 45 minutes after tubation	operation time（minutes）	45 minutes after tubation
operation time at the end of surgery	operation time（minutes）	at the end of surgery
operation time at 5 minutes after extubation	operation time（minutes）	5 minutes after extubation
operation time at 1 minute after extubation	operation time（mintes）	1 minute after extubation
estimated blood loss after the induction	estimated blood loss（ml）	during surgery
estimated blood loss after the participants are taken into the operating room	estimated blood loss（ml）	during surgery
estimated blood loss at 5 minutes after tubation	estimated blood loss（ml）	5 minutes after tubation
estimated blood loss at 10 minutes after tubation	estimated blood loss（ml）	10 minutes after tubation
estimated blood loss at 15 minutes after tubation	estimated blood loss（ml）	15 minutes after tubation
estimated blood loss at 30 minutes after tubation	estimated blood loss（ml）	30 minutes after tubation
estimated blood loss at 45minutes after tubation	estimated blood loss（ml）	45 minutes after tubation
estimated blood loss at the end of surgery	estimated blood loss（ml）	at the end of surgery
estimated blood loss at 1 minute after extubation	estimated blood loss（ml）	1 minute after extubation
estimated blood loss at 5 minutes after extubation	estimated blood loss（ml）	5 minutes after extubation
Scores of surgical field quality after the participants are taken into the operating room	Scores of surgical field quality by Fromme et al. and Boezzart et al.(Score 5 means massive uncontrollable bleeding.Score 4 means heavy but controllable bleeding, significant interference with dissection.Score 3 means moderate bleeding,modest compromise of the surgical field. Score 2 means moderate bleeding,nuisance in regard to the surgical field ,but no actual compromise of the ability to dissect.Score 1 means mild bleeding,but no interference with dissection.Score 0 means minimal bleeding,very dry field).	during surgery

Collaborators and Investigators

• Sponsor: Liang Bing

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Anticipated): September 30, 2019
• Study Completion (Anticipated): September 30, 2019

Study Registration Dates

• First Submitted: March 5, 2019
• First Submitted That Met QC Criteria: April 12, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 12, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: blood loss; oxygen consumption; controlled hypotension; cardiac output on; surgical field; oxygen supply
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Vasodilator Agents; Nitroglycerin
• Other Study ID Numbers: 2018-032-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No