跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NCT03917004
NCT03917004Unknown不适用

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

Liang Bing1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2019年4月1日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
160
试验地点
1
主要终点
cardiac index(CI) at 10 minutes after tubation
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
35 Years 至 70 Years（Adult, Older Adult）
性别
All
接受健康志愿者
是

入选标准

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

排除标准

  • •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

研究组 & 干预措施

hypotension group (group H )

Experimental

particcipants in hypotension group are received controlled hypertension in the operation.

干预措施: Nitroglycerin (Drug)

结局指标

主要结局

cardiac index(CI) at 10 minutes after tubation

时间窗: 10 minutes after tubation

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

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

时间窗: during surgery

CI(L/min/m\^2)

cardiac index(CI) after the induction

时间窗: during surgery

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

cardiac index(CI) at the end of surgery

时间窗: at the end of surgery

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

cardiac index(CI) at 1 minute after extubation

时间窗: 1 minute after extubation

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

cardiac index(CI) at 5 minutes after extubation

时间窗: 5 minutes after extubation

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

cardiac index(CI) at 5 minutes after tubation

时间窗: 5 minutes after tubation

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

cardiac index(CI) at 30 minutes after tubation

时间窗: 30 minutes after tubation

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

cardiac index(CI) at 45 minutes after tubation

时间窗: 45 minutes after tubation

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

cardiac index(CI) at 15 minutes after tubation

时间窗: 15 minutes after tubation

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

次要结局

  • central venous pressure(CVP) after the induction(during surgery)
  • mean artery pressure(MAP) after the induction(during surgery)
  • Partial pressure central venous oxygen after the induction(during surgery)
  • Central venous blood oxygen saturation after the induction(during surgery)
  • Oxygen supply index after the induction(during surgery)
  • Oxygen consumption index after the induction(during surgery)
  • Partial pressure of oxygen at 5 minutes after tubation(5 minutes after tubation)
  • Arterial oxygen saturation at 5 minutes after tubation(5 minutes after tubation)
  • Arterial blood hemoglobin at 5 minutes after tubation(5 minutes after tubation)
  • Arterial blood lactate at 5 minutes after tubation(5 minutes after tubation)
  • Partial pressure central venous oxygen at 5 minutes after tubation(5 minutes after tubation)
  • Central venous blood oxygen saturation at 5 minutes after tubation(5 minutes after tubation)
  • Oxygen supply index at 5 minutes after tubation(5 minutes after tubation)
  • Oxygen consumption index at 5 minutes after tubation(5 minutes after tubation)
  • Partial pressure of oxygen after the participants are taken into the operating room(during surgery)
  • Arterial oxygen saturation after the participants are taken into the operating room(during surgery)
  • Arterial blood hemoglobin after the participants are taken into the operating room(during surgery)
  • Arterial blood lactate after the participants are taken into the operating room(during surgery)
  • Partial pressure central venous oxygen after the participants are taken into the operating room(during surgery)
  • Central venous blood oxygen saturation after the participants are taken into the operating room(during surgery)
  • Oxygen supply index after the participants are taken into the operating room(during surgery)
  • Oxygen consumption index after the participants are taken into the operating room(during surgery)
  • Partial pressure of oxygen after the induction(during surgery)
  • Arterial oxygen saturation after the induction(during surgery)
  • Arterial blood hemoglobin after the induction(during surgery)
  • Arterial blood lactate after the induction(during surgery)
  • Arterial oxygen saturation at 10 minutes after tubation(10 minutes after tubation)
  • Arterial blood hemoglobin at 10 minutes after tubation(10 minutes after tubation)
  • Arterial blood lactate at 10 minutes after tubation(10 minutes after tubation)
  • Partial pressure central venous oxygen at 10 minutes after tubation(10 minutes after tubation)
  • Central venous blood oxygen saturation at 10 minutes after tubation(10 minutes after tubation)
  • Oxygen supply index at 10 minutes after tubation(10 minutes after tubation)
  • Oxygen consumption index at 10 minutes after tubation(10 minutes after tubation)
  • Partial pressure of oxygen at 15 minutes after tubation(15 minutes after tubation)
  • Arterial oxygen saturation at 15 minutes after tubation(15 minutes after tubation)
  • Partial pressure of oxygen at 10 minutes after tubation(10 minutes after tubation)
  • Arterial blood hemoglobin at 15 minutes after tubation(15 minutes after tubation)
  • Arterial blood lactate at 15 minutes after tubation(15 minutes after tubation)
  • Partial pressure central venous oxygen at 15 minutes after tubation(15 minutes after tubation)
  • Central venous blood oxygen saturation at 15 minutes after tubation(15 minutes after tubation)
  • Oxygen supply index at 15 minutes after tubation(15 minutes after tubation)
  • Calculated index at 15 minutes after tubation(15 minutes after tubation)
  • Partial pressure of oxygen at 30 minutes after tubation(30 minutes after tubation)
  • Arterial oxygen saturation at 30 minutes after tubation(30 minutes after tubation)
  • Arterial blood hemoglobin at 30 minutes after tubation(30 minutes after tubation)
  • Arterial blood lactate at 30 minutes after tubation(30 minutes after tubation)
  • Partial pressure of oxygen at the end of surgery(at the end of surgery)
  • Arterial oxygen saturation at the end of surgery(at the end of surgery)
  • Partial pressure central venous oxygen at 30 minutes after tubation(30 minutes after tubation)
  • Central venous blood oxygen saturation at 30 minutes after tubation(30 minutes after tubation)
  • Oxygen supply index at 30 minutes after tubation(30 minutes after tubation)
  • Oxygen consumption index at 30 minutes after tubation(30 minutes after tubation)
  • Partial pressure of oxygen at 45 minutes after tubation(45 minutes after tubation)
  • Arterial oxygen saturation at 45 minutes after tubation(45 minutes after tubation)
  • Arterial blood hemoglobin at 45 minutes after tubation(45 minutes after tubation)
  • Partial pressure central venous oxygen at 45 minutes after tubation(45 minutes after tubation)
  • Arterial blood lactate at 45 minutes after tubation(45 minutes after tubation)
  • Oxygen supply index at 45 minutes after tubation(45 minutes after tubation)
  • Oxygen consumption index at 45 minutes after tubation(45 minutes after tubation)
  • Central venous blood oxygen saturation at 45 minutes after tubation(45 minutes after tubation)
  • Arterial blood hemoglobin at the end of surgery(at the end of surgery)
  • Arterial blood lactate at the end of surgery(at the end of surgery)
  • Partial pressure central venous oxygen at the end of surgery(at the end of surgery)
  • Central venous blood oxygen saturation at the end of surgery(at the end of surgery)
  • Oxygen supply index at the end of surgery(at the end of surgery)
  • Oxygen consumption index at the end of surgery(at the end of surgery)
  • Partial pressure of oxygen at 1 minute after extubation(1 minute after extubation)
  • Arterial oxygen saturation at 1 minute after extubation(1 minute after extubation)
  • Arterial blood hemoglobin at 1 minute after extubation(1 minute after extubation)
  • Arterial blood lactate at 1 minute after extubation(1 minute after extubation)
  • Partial pressure central venous oxygen at 1 minute after extubation(1 minute after extubation)
  • Central venous blood oxygen saturation at 1 minute after extubation(1 minute after extubation)
  • Oxygen supply index at 1 minute after extubation(1 minute after extubation)
  • Oxygen consumption index at 1 minute after extubation(1 minute after extubation)
  • Plartia pressure of oxygen at 5 minutes after extubation(5 minutes after extubation)
  • Arterial oxygen saturation at 5 minutes after extubation(5 minutes after extubation)
  • Arterial blood hemoglobin at 5 minutes after extubation(5 minutes after extubation)
  • Arterial blood lactate at 5 minutes after extubation(5 minutes after extubation)
  • Partial pressure central venous oxygen at 5 minutes after extubation(5 minutes after extubation)
  • Central venous blood oxygen saturation at 5 minutes after extubation(5 minutes after extubation)
  • Oxygen supply index at 5 minutes after extubation(5 minutes after extubation)
  • Oxygen consumption index at 5 minutes after extubation(5 minutes after extubation)
  • mean artery pressure(MAP) after the participants are taken into the operatin after the participantsg room(during surgery)
  • heart rate(HR) after the participants are taken into the operating room(during surgery)
  • central venous pressure(CVP) after the participants are taken into the operating room(during surgery)
  • variability of stroke volume(SVV) after the participants are taken into the operating room(during surgery)
  • heart rate(HR) after the induction(during surgery)
  • variability of stroke volume(SVV) after the induction(during surgery)
  • mean artery pressure(MAP) at 5 minutes after tubation(5 minutes after tubation)
  • heart rate(HR) at 5 minutes after tubation(5 minutes after tubation)
  • central venous pressure(CVP) at 5 minutes after tubation(5 minutes after tubation)
  • variability of stroke volume(SVV) at 5 minutes after tubation(5 minutes after tubation)
  • mean artery pressure(MAP) at 10 minutes after tubation(10 minutes after tubation)
  • heart rate(HR) at 10 minutes after tubation(10 minutes after tubation)
  • central venous pressure(CVP) at 10 minutes after tubation(10 minutes after tubation)
  • variability of stroke volume(SVV) at 10 minutes after tubation(10 minutes after tubation)
  • mean artery pressure(MAP) at 15 minutes after tubation(15 minutes after tubation)
  • heart rate(HR) at 15 minutes after tubation(15 minutes after tubation)
  • central venous pressure(CVP) at 15 minutes after tubation(15 minutes after tubation)
  • variability of stroke volume(SVV) at 15 minutes after tubation(15 minutes after tubation)
  • mean artery pressure(MAP) at 30 minutes after tubation(30 minutes after tubation)
  • heart rate(HR) at 30 minutes after tubation(30 minutes after tubation)
  • central venous pressure(CVP) at 30 minutes after tubation(30 minutes after tubation)
  • variability of stroke volume(SVV) at 30 minutes after tubation(30 minutes after tubation)
  • mean artery pressure(MAP) at 45 minutes after tubation(45 minutes after tubation)
  • heart rate(HR) at 45 minutes after tubation(45 minutes after tubation)
  • central venous pressure(CVP) at the end of surgery(at the end of surgery)
  • central venous pressure(CVP) at 45 minutes after tubation(45 minutes after tubation)
  • variability of stroke volume(SVV) at 45 minutes after tubation(45 minutes after tubation)
  • mean artery pressure(MAP) at the end of surgery(at the end of surgery)
  • heart rate(HR) at 1 minute after extubation(1 minute after extubation)
  • variability of stroke volume(SVV) at 1 minute after extubation(1 minute after extubation)
  • central venous pressure(CVP) at 1 minute after extubation(1 minute after extubation)
  • mean artery pressure(MAP) at 5 minutes after extubation(5 minutes after extubation)
  • mean artery pressure(MAP) at 1 minute after extubation(1 minute after extubation)
  • variability of stroke volume(SVV) at the end of surgery(at the end of surgery)
  • central venous pressure(CVP) at 5 minutes after extubation(5 minutes after extubation)
  • heart rate(HR) at 5 minutes after extubation(5 minutes after extubation)
  • heart rate(HR) at the end of surgery(at the end of surgery)
  • variability of stroke volume(SVV) at 5 minutes after extubation(5 minutes after extubation)

研究者

发起方
Liang Bing
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Liang Bing

Associate chief physician

Guangzhou Red Cross Hospital

研究点 (1)

Loading locations...

相似试验

已完成
不适用
Physical Activity in Relation to Surgical ProceduresSurgeryColorectal Cancer
NCT02299596Sahlgrenska University Hospital761
已完成
不适用
Study Assessing Impact of Dermatology Consultation for Patients Admitted With CellulitisCellulitis
NCT01706913Massachusetts General Hospital246
已完成
不适用
Evaluation of Safety of HEMOBLAST Bellows in Spine SurgerySurgical Bleeding
NCT04734535Dilon Technologies Inc.60
撤回
不适用
Post Surgically Treated Peritonitis ComplicationsPeritonitis
NCT03284476Nantes University Hospital
已完成
不适用
Effects of the Spinal Manipulative Therapy and Myofascial Release in Individuals With Non-specific Chronic Low Back PainChronic Low Back Pain
NCT03434990University of Brasilia90