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

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.

Study Overview

• Status: Recruiting
• Conditions: Asana Adjustment
• Intervention / Treatment: Behavioral: Asana adjustment

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhuan Zhang; Phone Number: +8615062791355; Email: zhangzhuancg@163.com

Study Locations

• China
  • Jiangsu
    • Yangzhou, Jiangsu, China
      • Recruiting
      • the Affiliated Hospital of Yangzhou University, Yangzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trendelenburg position	Behavioral: Asana adjustment; 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.
No Intervention: Procumbent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra-abdominal pressure level	Intra-abdominal pressure	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	Vasoactive drug dosage	Intraoperatively

Collaborators and Investigators

• Sponsor: Zhuan Zhang

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Anticipated): October 30, 2023
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: February 18, 2023
• First Submitted That Met QC Criteria: February 18, 2023
• First Posted (Actual): March 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 18, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Intra-abdominal pressure; Cardiac output; Prone Position; Hemodynamics; Trendelenburg position
• Other Study ID Numbers: 20230218

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No