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

NCT03917004 | Unknown

• 1 other identifier: 2018-032-01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension,Controlled

Keywords

controlled hypotension; cardiac output on; blood loss; surgical field; oxygen supply; oxygen consumption

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (120)

• 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

Other Outcomes (30)

• Scores of surgical field quality after the induction

  during surgery

• Scores of surgical field quality at 5 minutes after tubation

  5 minutes after tubation

• Scores of surgical field quality at 10 minutes after tubation

  10 minutes after tubation

Study Arms (2)

hypotension group (group H )

EXPERIMENTAL

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

Drug: Nitroglycerin

control group (group C )

NO INTERVENTION

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

Interventions

Nitroglycerin DRUG

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.

Also known as: Controlled Hypotension

hypotension group (group H )

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Liang Bing: lead

Study Sites (1)

Guangzhou Red cross hospital

Guangzhou, Guangdong, 510220, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 25859171 BACKGROUND

• 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.

  PMID: 23162401 BACKGROUND

MeSH Terms

Conditions

Hypotension; Hemorrhage

Interventions

Nitroglycerin; Hypotension, Controlled

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitro Compounds; Organic Chemicals; Anesthesia and Analgesia

Study Officials

• Cao Yang

  Guangzhou Red Cross Hospital

  STUDY DIRECTOR

Central Study Contacts

Cao Yang

CONTACT

+86-020-34403854; caoy2008@163.com

Yang

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate chief physician

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: April 16, 2019
• Study Start: April 1, 2019
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)