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

• Sponsor: Zhuan Zhang (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05749978
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 2.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asana Adjustment	Behavioral: Asana adjustment	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Effects of Postural Adjustment on Hemodynamics in Patients Undergoing Prone Spine Surgery Under General Anesthesia
• Actual Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: Oct 30, 2023
• Anticipated Study Completion Date: Dec 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Blood 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]

   Hemodynamics

2. Changes in the level of 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]

   Cardiac output

Secondary Outcome Measures

1. 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]

   Intra-abdominal pressure

2. Vasoactive drugs [Intraoperatively]

   Vasoactive drug dosage

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	the Affiliated Hospital of Yangzhou University, Yangzhou University	Yangzhou	Jiangsu	China

Sponsors and Collaborators

• Zhuan Zhang

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhuan Zhang, Principal Investigator, Yangzhou University
• ClinicalTrials.gov Identifier: NCT05749978
• Other Study ID Numbers: 20230218
• First Posted: Mar 1, 2023
• Last Update Posted: Mar 1, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zhuan Zhang, Principal Investigator, Yangzhou University: Trendelenburg position; Prone Position; Hemodynamics; Intra-abdominal pressure; Cardiac output

Study Results

No Results Posted as of Mar 1, 2023