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

Liang Bing

Status: Unknown

Conditions: Hypotension,Controlled

Treatments: Drug: Nitroglycerin

Study type: Interventional

Funder types: Other

Identifiers

NCT03917004

2018-032-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 35 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

hypotension group (group H )

Experimental group

Description:

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

Treatment:

Drug: Nitroglycerin

control group (group C )

No Intervention group

Description:

participants in cotrol group are received no controlled hypertension in the operation