Effect of Trendelenburg Positioning on Anesthesia-Induced Hypotension in Elderly Patients

NCT06968091 | Completed DMC

• 1 other identifier: IRB-2025-478
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigated the effect of Trendelenburg position on preventing post-induction hypotension in elderly patients undergoing abdominal surgery with general anesthesia. The patients will receive the 10° Trendelenburg position or supine position during anesthesia induction. The primary outcome is the area under a mean arterial pressure (MAP) below 65 mm Hg within the first 15 minutes during anesthesia induction.

Conditions

Hypotension on Induction; Old Age

Outcome Measures

Primary Outcomes (1)

• The area under the curve of the mean arterial pressure being lower than 65 mmHg

  within 15 minutes after anesthesia induction

Secondary Outcomes (27)

• The area under the curve of the mean arterial pressure being lower than 60 mmHg

  within 15 minutes after anesthesia induction

• The area under the curve of the mean arterial pressure being lower than 50 mmHg

  within 15 minutes after anesthesia induction

• The area under the curve of the mean arterial pressure being lower than 40 mmHg

  within 15 minutes after anesthesia induction

• The duration during which the Mean Arterial Pressure (MAP) is less than 65 mmHg

  within 15 minutes after anesthesia induction

• The duration during which the Mean Arterial Pressure (MAP) is less than 60 mmHg

  within 15 minutes after anesthesia induction

Study Arms (2)

The Trendelenburg Position Group

EXPERIMENTAL

Other: Trendelenburg position

The Supine Horizontal Position Group

PLACEBO COMPARATOR

Other: Supine Horizontal Position

Interventions

Trendelenburg position OTHER

After the loss of consciousness during general anesthesia, the 10° Trendelenburg position is adopted.

The Trendelenburg Position Group

Supine Horizontal Position OTHER

After the loss of consciousness during general anesthesia, the Supine Horizontal Position is adopted.

The Supine Horizontal Position Group

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• patients aged 65-90 years
• scheduled for abdominal surgery with general anesthesia
• expected to have continuous radial arterial pressure monitoring
• American Society of Anesthesiologists (ASA) physical status I to III

You may not qualify if:

• contraindications or failure of radial arterial catheterization
• expected possible difficult airway
• non-sinus rhythm
• increased intracranial pressure
• patients at high risk of regurgitation or aspiration
• inability to provide consent

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang cancer hospital

Hangzhou, Zhejiang, China

Location

MeSH Terms

Interventions

Head-Down Tilt

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The anesthesiologists do not implement the blinding method for the patient grouping, while the physicians conducting the postoperative follow-up implement the blinding method for the grouping.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 3, 2025
• First Posted: May 13, 2025
• Study Start: May 16, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 3, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: starting about 6 months after publication

Locations

CN (1)