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Completed

NCT Number: NCT06968091

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

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.

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Key information

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhejiang cancer hospital

Hangzhou, Zhejiang, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Trendelenburg position

Other

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

Supine Horizontal Position

Other

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

Primary outcomes

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

    Time frame: within 15 minutes after anesthesia induction

Secondary outcomes

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

    Time frame: within 15 minutes after anesthesia induction

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

    Time frame: within 15 minutes after anesthesia induction

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

    Time frame: within 15 minutes after anesthesia induction

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

    Time frame: within 15 minutes after anesthesia induction

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

    Time frame: within 15 minutes after anesthesia induction

  6. The duration during which the Mean Arterial Pressure (MAP) is less than 50 mmHg

    Time frame: within 15 minutes after anesthesia induction

  7. The duration during which the Mean Arterial Pressure (MAP) is less than 40 mmHg

    Time frame: within 15 minutes after anesthesia induction

  8. The usage of vasoactive drugs

    Time frame: within 15 minutes after anesthesia induction and during the whole process of the surgery

    The vasoactive drugs are selected from the following according to the protocol: phenylephrine, ephedrine, norepinephrine, and epinephrine.

  9. The lowest mean arterial pressure

    Time frame: within 15 minutes after anesthesia induction

  10. the postoperative complications

    Time frame: within 30 days after surgery

    The complications are assessed using the Claviene-Dindo score.

  11. the postoperative recovery

    Time frame: on postoperative day 1

    The postoperative recovery is assessed using the quality of recovery-15 questionnaire (QoR-15) .The QoR-15 has 15 questions. Each question is rated on a 10-point scale, ranging from 0 (none of the time or poor) to 10 (all of the time or excellent). The maximum score (best recovery) is 150.

  12. Length of hospital stay after surgery

    Time frame: through study completion, an average of 3-15 days

  13. The time duration required to complete endotracheal intubation

    Time frame: through study completion, an average of 10-60 s

  14. The incidence of refractory hypotension

    Time frame: within 15 minutes after anesthesia induction

    If either of the following two definitions is met, it is considered refractory hypotension:

    • During the anesthesia induction period, the total administered dosage exceeds the maximum dose, and the patient's hypotension does not recover. The maximum usage dose of ephedrine is 0.5 mg/kg (ideal body weight), and the maximum usage dose of phenylephrine is 8 μg/kg (ideal body weight).
    • When two or more vasoactive drugs are used, the systolic blood pressure is less than 80 mmHg or the mean blood pressure is less than 65 mmHg continuously for more than 5 minutes.
  15. The number of attempts at tracheal intubation

    Time frame: through study completion, an average of 1-2times

  16. The dosage of propofol during the anesthesia induction period

    Time frame: within 15 minutes after anesthesia induction

  17. The dosage of remifentanil during the anesthesia induction period

    Time frame: within 15 minutes after anesthesia induction

  18. The VIDIAC score of the video laryngoscope.

    Time frame: through study completion, an average of -1~1 points

    The VIDIAC score is comprised of: E, the interaction between the blade tip and epiglottis; V, the best view of the vocal cords from the blade camera; and A, enlargement of the arytenoids. The score range of the VIDIAC score is from -1 to 5 points. The VIDIAC score classification is as follows: Easy, with a score of -1 or 0; Moderate, with a score of 1; Difficult, with a score of 2; Severe, with a score of ≥3.

  19. The usage of other medications during the anesthesia induction period

    Time frame: within 15 minutes after anesthesia induction

    The usage of medications other than propofol, remifentanil, phenylephrine, ephedrine, norepinephrine, and epinephrine.

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

    Time frame: within 20 minutes after anesthesia induction

  21. The pulse pressure variation rate after mechanical ventilation.

    Time frame: At the 1st, 3rd, 5th and 10th minutes after tracheal intubation

  22. The peak airway pressure after mechanical ventilation.

    Time frame: At the 1st minutes after tracheal intubation

  23. The infusion volume of crystalloid solution during the induction period.

    Time frame: within 15 minutes after anesthesia induction

  24. Arterial systolic pressure after anesthesia induction

    Time frame: At the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 8th, 9th, 10th, 11th, 12th, 13th, 14th, 15th, 16th, 17th, 18th, 19th and 20th minutes after anesthesia induction.

    The monitor records continuous arterial blood pressure data at intervals of 1 second.

  25. Arterial diastolic pressure after anesthesia induction

    Time frame: At the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 8th, 9th, 10th, 11th, 12th, 13th, 14th, 15th, 16th, 17th, 18th, 19th and 20th minutes after anesthesia induction.

    The monitor records continuous arterial blood pressure data at intervals of 1 second.

  26. Mean arterial pressure after anesthesia induction

    Time frame: At the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 8th, 9th, 10th, 11th, 12th, 13th, 14th, 15th, 16th, 17th, 18th, 19th and 20th minutes after anesthesia induction.

    The monitor records continuous arterial blood pressure data at intervals of 1 second.

  27. Heart rate after anesthesia induction

    Time frame: At the 1st, 2nd, 3rd, 4th, 5th, 6th, 7th, 8th, 9th, 10th, 11th, 12th, 13th, 14th, 15th, 16th, 17th, 18th, 19th and 20th minutes after anesthesia induction.

Sponsors and collaborators

Lead sponsor

Zhejiang Cancer Hospital

Other

Registry information

Official study title

Effect of Trendelenburg Positioning on Anesthesia-Induced Hypotension in Elderly Patients: A Randomized Controlled Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 13, 2025
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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