Effects of Postural Adjustment on Hemodynamics in Patients Undergoing Prone Spine Surgery Under General Anesthesia

NCT05749978 | Unknown

• 1 other identifier: 20230218
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The prone position is a special position often used for spinal surgery. As a special position of general anesthesia, after induction of general anesthesia, severe hemodynamic fluctuations often occur when the supine position is changed to the prone position, which seriously affects the patient's circulatory and respiratory functions.

Conditions

Asana Adjustment

Keywords

Trendelenburg position; Prone Position; Hemodynamics; Intra-abdominal pressure; Cardiac output

Outcome Measures

Primary Outcomes (2)

• Change in Blood pressure

  Hemodynamics

  Preoperatively,5 minute after anesthesia induction,Immediately before the prone position, Immediately after the prone position,1 minute after prone position, 3 minute after prone position,10 minute after prone position,Half an hour after prone position

• Changes in the level of Cardiac output

  Cardiac output

  Preoperatively,5 minute after anesthesia induction,Immediately before the prone position, Immediately after the prone position,1 minute after prone position, 3 minute after prone position,10 minute after prone position,Half an hour after prone position

Secondary Outcomes (2)

• Intra-abdominal pressure level

  Preoperatively,5 minute after anesthesia induction,Immediately before the prone position, Immediately after the prone position,1 minute after prone position, 3 minute after prone position,10 minute after prone position,Half an hour after prone position

• Vasoactive drugs

  Intraoperatively

Study Arms (2)

Trendelenburg position

EXPERIMENTAL

Behavioral: Asana adjustment

Procumbent

NO INTERVENTION

Interventions

Asana adjustment BEHAVIORAL

Adjust the operating table to 15° head height and foot low in advance. The patient is then slowly turned over from the transport table to the operating table and completed in the prone position. After the patient's hemodynamic stability is smooth, adjust the operating table to the level.

Trendelenburg position

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prone spine surgery after general anesthesia is planned.
• Age 18\~85 years old.
• ASA grade I or II.
• BMI18.3-30kg/m2

You may not qualify if:

• Unstable angina or myocardial infarction, coronary heart disease, congestive heart failure, structural heart disease, arrhythmia within 6 months;
• Increased intracranial pressure and central nervous system injury or disease;
• Severe hypertension
• Patients with other diseases affecting their own circulatory system.
• Have or have a history of severe mental disorders;
• Bleeding volume \>600ml or intraoperative blood transfusion treatment.
• Severe liver and kidney insufficiency

Sponsors & Collaborators

• Zhuan Zhang: lead

Study Sites (1)

the Affiliated Hospital of Yangzhou University, Yangzhou University

Yangzhou, Jiangsu, China

RECRUITING

Central Study Contacts

Zhuan Zhang

CONTACT

+8615062791355; zhangzhuancg@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 18, 2023
• First Posted: March 1, 2023
• Study Start: January 1, 2023
• Primary Completion: October 30, 2023
• Study Completion: December 30, 2024
• Last Updated: March 1, 2023

Record last verified: 2023-01

Locations

CN (1)