Clinical trial NCT03917004: Correlation Analysis of the Effects of Management Pressure Goals and Control Volume Goals in Patients in Spinal Surgery
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypotension,Controlled
Keywords: controlled hypotension
cardiac output on
blood loss
surgical field
oxygen supply
oxygen consumption
Lead sponsor: Guangzhou Red Cross Hospital
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 160
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: cardiac index(CI) after the participants are taken into the operating room
timeFrame: during surgery
measure: cardiac index(CI) after the induction
timeFrame: during surgery
measure: cardiac index(CI) at 5 minutes after tubation
timeFrame: 5 minutes after tubation
measure: cardiac index(CI) at 10 minutes after tubation
timeFrame: 10 minutes after tubation
measure: cardiac index(CI) at 15 minutes after tubation
timeFrame: 15 minutes after tubation
measure: cardiac index(CI) at 30 minutes after tubation
timeFrame: 30 minutes after tubation
measure: cardiac index(CI) at 45 minutes after tubation
timeFrame: 45 minutes after tubation
measure: cardiac index(CI) at the end of surgery
timeFrame: at the end of surgery
measure: cardiac index(CI) at 1 minute after extubation
timeFrame: 1 minute after extubation
measure: cardiac index(CI) at 5 minutes after extubation
timeFrame: 5 minutes after extubation
Secondary outcomes:
measure: Partial pressure of oxygen after the participants are taken into the operating room
timeFrame: during surgery
measure: Arterial oxygen saturation after the participants are taken into the operating room
timeFrame: during surgery
measure: Arterial blood hemoglobin after the participants are taken into the operating room
timeFrame: during surgery
measure: Arterial blood lactate after the participants are taken into the operating room
timeFrame: during surgery
measure: Partial pressure central venous oxygen after the participants are taken into the operating room
timeFrame: during surgery
measure: Central venous blood oxygen saturation after the participants are taken into the operating room
timeFrame: during surgery
measure: Oxygen supply index after the participants are taken into the operating room
timeFrame: during surgery
measure: Oxygen consumption index after the participants are taken into the operating room
timeFrame: during surgery
measure: Partial pressure of oxygen after the induction
timeFrame: during surgery
measure: Arterial oxygen saturation after the induction
timeFrame: during surgery
measure: Arterial blood hemoglobin after the induction
timeFrame: during surgery
measure: Arterial blood lactate after the induction
timeFrame: during surgery
measure: Partial pressure central venous oxygen after the induction
timeFrame: during surgery
measure: Central venous blood oxygen saturation after the induction
timeFrame: during surgery
measure: Oxygen supply index after the induction
timeFrame: during surgery
measure: Oxygen consumption index after the induction
timeFrame: during surgery
measure: Partial pressure of oxygen at 5 minutes after tubation
timeFrame: 5 minutes after tubation
measure: Arterial oxygen saturation at 5 minutes after tubation
timeFrame: 5 minutes after tubation
measure: Arterial blood hemoglobin at 5 minutes after tubation
timeFrame: 5 minutes after tubation
measure: Arterial blood lactate at 5 minutes after tubation
timeFrame: 5 minutes after tubation
measure: Partial pressure central venous oxygen at 5 minutes after tubation
timeFrame: 5 minutes after tubation
measure: Central venous blood oxygen saturation at 5 minutes after tubation
timeFrame: 5 minutes after tubation
measure: Oxygen supply index at 5 minutes after tubation
timeFrame: 5 minutes after tubation
measure: Oxygen consumption index at 5 minutes after tubation
timeFrame: 5 minutes after tubation
measure: Partial pressure of oxygen at 10 minutes after tubation
timeFrame: 10 minutes after tubation
measure: Arterial oxygen saturation at 10 minutes after tubation
timeFrame: 10 minutes after tubation
measure: Arterial blood hemoglobin at 10 minutes after tubation
timeFrame: 10 minutes after tubation
measure: Arterial blood lactate at 10 minutes after tubation
timeFrame: 10 minutes after tubation
measure: Partial pressure central venous oxygen at 10 minutes after tubation
timeFrame: 10 minutes after tubation
measure: Central venous blood oxygen saturation at 10 minutes after tubation
timeFrame: 10 minutes after tubation
measure: Oxygen supply index at 10 minutes after tubation
timeFrame: 10 minutes after tubation
measure: Oxygen consumption index at 10 minutes after tubation
timeFrame: 10 minutes after tubation
measure: Partial pressure of oxygen at 15 minutes after tubation
timeFrame: 15 minutes after tubation
measure: Arterial oxygen saturation at 15 minutes after tubation
timeFrame: 15 minutes after tubation
measure: Arterial blood hemoglobin at 15 minutes after tubation
timeFrame: 15 minutes after tubation
measure: Arterial blood lactate at 15 minutes after tubation
timeFrame: 15 minutes after tubation
measure: Partial pressure central venous oxygen at 15 minutes after tubation
timeFrame: 15 minutes after tubation
measure: Central venous blood oxygen saturation at 15 minutes after tubation
timeFrame: 15 minutes after tubation
measure: Oxygen supply index at 15 minutes after tubation
timeFrame: 15 minutes after tubation
measure: Calculated index at 15 minutes after tubation
timeFrame: 15 minutes after tubation
measure: Partial pressure of oxygen at 30 minutes after tubation
timeFrame: 30 minutes after tubation
measure: Arterial oxygen saturation at 30 minutes after tubation
timeFrame: 30 minutes after tubation
measure: Arterial blood hemoglobin at 30 minutes after tubation
timeFrame: 30 minutes after tubation
measure: Arterial blood lactate at 30 minutes after tubation
timeFrame: 30 minutes after tubation
measure: Partial pressure central venous oxygen at 30 minutes after tubation
timeFrame: 30 minutes after tubation
measure: Central venous blood oxygen saturation at 30 minutes after tubation
timeFrame: 30 minutes after tubation
measure: Oxygen supply index at 30 minutes after tubation
timeFrame: 30 minutes after tubation
measure: Oxygen consumption index at 30 minutes after tubation
timeFrame: 30 minutes after tubation
measure: Partial pressure of oxygen at 45 minutes after tubation
timeFrame: 45 minutes after tubation
measure: Arterial oxygen saturation at 45 minutes after tubation
timeFrame: 45 minutes after tubation
measure: Arterial blood hemoglobin at 45 minutes after tubation
timeFrame: 45 minutes after tubation
measure: Partial pressure central venous oxygen at 45 minutes after tubation
timeFrame: 45 minutes after tubation
measure: Arterial blood lactate at 45 minutes after tubation
timeFrame: 45 minutes after tubation
measure: Oxygen supply index at 45 minutes after tubation
timeFrame: 45 minutes after tubation
measure: Oxygen consumption index at 45 minutes after tubation
timeFrame: 45 minutes after tubation
measure: Central venous blood oxygen saturation at 45 minutes after tubation
timeFrame: 45 minutes after tubation
measure: Partial pressure of oxygen at the end of surgery
timeFrame: at the end of surgery
measure: Arterial oxygen saturation at the end of surgery
timeFrame: at the end of surgery
measure: Arterial blood hemoglobin at the end of surgery
timeFrame: at the end of surgery
measure: Arterial blood lactate at the end of surgery
timeFrame: at the end of surgery
measure: Partial pressure central venous oxygen at the end of surgery
timeFrame: at the end of surgery
measure: Central venous blood oxygen saturation at the end of surgery
timeFrame: at the end of surgery
measure: Oxygen supply index at the end of surgery
timeFrame: at the end of surgery
measure: Oxygen consumption index at the end of surgery
timeFrame: at the end of surgery
measure: Partial pressure of oxygen at 1 minute after extubation
timeFrame: 1 minute after extubation
measure: Arterial oxygen saturation at 1 minute after extubation
timeFrame: 1 minute after extubation
measure: Arterial blood hemoglobin at 1 minute after extubation
timeFrame: 1 minute after extubation
measure: Arterial blood lactate at 1 minute after extubation
timeFrame: 1 minute after extubation
measure: Partial pressure central venous oxygen at 1 minute after extubation
timeFrame: 1 minute after extubation
measure: Central venous blood oxygen saturation at 1 minute after extubation
timeFrame: 1 minute after extubation
measure: Oxygen supply index at 1 minute after extubation
timeFrame: 1 minute after extubation
measure: Oxygen consumption index at 1 minute after extubation
timeFrame: 1 minute after extubation
measure: Plartia pressure of oxygen at 5 minutes after extubation
timeFrame: 5 minutes after extubation
measure: Arterial oxygen saturation at 5 minutes after extubation
timeFrame: 5 minutes after extubation
measure: Arterial blood hemoglobin at 5 minutes after extubation
timeFrame: 5 minutes after extubation
measure: Arterial blood lactate at 5 minutes after extubation
timeFrame: 5 minutes after extubation
measure: Partial pressure central venous oxygen at 5 minutes after extubation
timeFrame: 5 minutes after extubation
measure: Central venous blood oxygen saturation at 5 minutes after extubation
timeFrame: 5 minutes after extubation
measure: Oxygen supply index at 5 minutes after extubation
timeFrame: 5 minutes after extubation
measure: Oxygen consumption index at 5 minutes after extubation
timeFrame: 5 minutes after extubation
measure: mean artery pressure(MAP) after the participants are taken into the operatin after the participantsg room
timeFrame: during surgery
measure: heart rate(HR) after the participants are taken into the operating room
timeFrame: during surgery
measure: central venous pressure(CVP) after the participants are taken into the operating room
timeFrame: during surgery
measure: variability of stroke volume(SVV) after the participants are taken into the operating room
timeFrame: during surgery
measure: mean artery pressure(MAP) after the induction
timeFrame: during surgery
measure: heart rate(HR) after the induction
timeFrame: during surgery
measure: central venous pressure(CVP) after the induction
timeFrame: during surgery
measure: variability of stroke volume(SVV) after the induction
timeFrame: during surgery
measure: mean artery pressure(MAP) at 5 minutes after tubation
timeFrame: 5 minutes after tubation
measure: heart rate(HR) at 5 minutes after tubation
timeFrame: 5 minutes after tubation
measure: central venous pressure(CVP) at 5 minutes after tubation
timeFrame: 5 minutes after tubation
measure: variability of stroke volume(SVV) at 5 minutes after tubation
timeFrame: 5 minutes after tubation
measure: mean artery pressure(MAP) at 10 minutes after tubation
timeFrame: 10 minutes after tubation
measure: heart rate(HR) at 10 minutes after tubation
timeFrame: 10 minutes after tubation
measure: central venous pressure(CVP) at 10 minutes after tubation
timeFrame: 10 minutes after tubation
measure: variability of stroke volume(SVV) at 10 minutes after tubation
timeFrame: 10 minutes after tubation
measure: mean artery pressure(MAP) at 15 minutes after tubation
timeFrame: 15 minutes after tubation
measure: heart rate(HR) at 15 minutes after tubation
timeFrame: 15 minutes after tubation
measure: central venous pressure(CVP) at 15 minutes after tubation
timeFrame: 15 minutes after tubation
measure: variability of stroke volume(SVV) at 15 minutes after tubation
timeFrame: 15 minutes after tubation
measure: mean artery pressure(MAP) at 30 minutes after tubation
timeFrame: 30 minutes after tubation
measure: heart rate(HR) at 30 minutes after tubation
timeFrame: 30 minutes after tubation
measure: central venous pressure(CVP) at 30 minutes after tubation
timeFrame: 30 minutes after tubation
measure: variability of stroke volume(SVV) at 30 minutes after tubation
timeFrame: 30 minutes after tubation
measure: mean artery pressure(MAP) at 45 minutes after tubation
timeFrame: 45 minutes after tubation
measure: heart rate(HR) at 45 minutes after tubation
timeFrame: 45 minutes after tubation
measure: central venous pressure(CVP) at 45 minutes after tubation
timeFrame: 45 minutes after tubation
measure: variability of stroke volume(SVV) at 45 minutes after tubation
timeFrame: 45 minutes after tubation
measure: mean artery pressure(MAP) at the end of surgery
timeFrame: at the end of surgery
measure: central venous pressure(CVP) at the end of surgery
timeFrame: at the end of surgery
measure: variability of stroke volume(SVV) at the end of surgery
timeFrame: at the end of surgery
measure: heart rate(HR) at the end of surgery
timeFrame: at the end of surgery
measure: mean artery pressure(MAP) at 1 minute after extubation
timeFrame: 1 minute after extubation
measure: heart rate(HR) at 1 minute after extubation
timeFrame: 1 minute after extubation
measure: variability of stroke volume(SVV) at 1 minute after extubation
timeFrame: 1 minute after extubation
measure: central venous pressure(CVP) at 1 minute after extubation
timeFrame: 1 minute after extubation
measure: mean artery pressure(MAP) at 5 minutes after extubation
timeFrame: 5 minutes after extubation
measure: central venous pressure(CVP) at 5 minutes after extubation
timeFrame: 5 minutes after extubation
measure: heart rate(HR) at 5 minutes after extubation
timeFrame: 5 minutes after extubation
measure: variability of stroke volume(SVV) at 5 minutes after extubation
timeFrame: 5 minutes after extubation
Other outcomes:
measure: Scores of surgical field quality after the induction
timeFrame: during surgery
measure: Scores of surgical field quality at 5 minutes after tubation
timeFrame: 5 minutes after tubation
measure: Scores of surgical field quality at 10 minutes after tubation
timeFrame: 10 minutes after tubation
measure: Scores of surgical field quality at 15 minutes after tubation
timeFrame: 15 minutes after tubation
measure: Scores of surgical field quality at 30 minutes after tubation
timeFrame: 30 minutes after tubation
measure: Scores of surgical field quality at 45 minutes after tubation
timeFrame: 45 minutes after tubation
measure: Scores of surgical field quality at the end of surgery
timeFrame: at the end of surgery
measure: Scores of surgical field quality at 5 minutes after extubation
timeFrame: 5 minutes after extubation
measure: Scores of surgical field quality at 1 minute after extubation
timeFrame: 1 minute after extubation
measure: operation time after the induction
timeFrame: during surgery
measure: operation time after the participants are taken into the operating room
timeFrame: during surgery
measure: operation time at 5 minutes after tubation
timeFrame: 5 minutes after tubation
measure: operation time at 10 minutes after tubation
timeFrame: 10 minutes after tubation
measure: operation time at 15 minutes after tubation
timeFrame: 15 minutes after tubation
measure: operation time at 30 minutes after tubation
timeFrame: 30 minutes after tubation
measure: operation time at 45 minutes after tubation
timeFrame: 45 minutes after tubation
measure: operation time at the end of surgery
timeFrame: at the end of surgery
measure: operation time at 5 minutes after extubation
timeFrame: 5 minutes after extubation
measure: operation time at 1 minute after extubation
timeFrame: 1 minute after extubation
measure: estimated blood loss after the induction
timeFrame: during surgery
measure: estimated blood loss after the participants are taken into the operating room
timeFrame: during surgery
measure: estimated blood loss at 5 minutes after tubation
timeFrame: 5 minutes after tubation
measure: estimated blood loss at 10 minutes after tubation
timeFrame: 10 minutes after tubation
measure: estimated blood loss at 15 minutes after tubation
timeFrame: 15 minutes after tubation
measure: estimated blood loss at 30 minutes after tubation
timeFrame: 30 minutes after tubation
measure: estimated blood loss at 45minutes after tubation
timeFrame: 45 minutes after tubation
measure: estimated blood loss at the end of surgery
timeFrame: at the end of surgery
measure: estimated blood loss at 1 minute after extubation
timeFrame: 1 minute after extubation
measure: estimated blood loss at 5 minutes after extubation
timeFrame: 5 minutes after extubation
measure: Scores of surgical field quality after the participants are taken into the operating room
timeFrame: during surgery
Locations:
city: Guangzhou
country: China
facility: Guangzhou Red cross hospital
state: Guangdong
Study officials:
affiliation: Guangzhou Red Cross Hospital
name: Cao Yang
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.