Clinical trial NCT06968091: Effect of Trendelenburg Positioning on Anesthesia-Induced Hypotension in Elderly Patients
Official title: Effect of Trendelenburg Positioning on Anesthesia-Induced Hypotension in Elderly Patients: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypotension on Induction
Old Age
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 168
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: The area under the curve of the mean arterial pressure being lower than 65 mmHg
timeFrame: within 15 minutes after anesthesia induction
Secondary outcomes:
measure: The area under the curve of the mean arterial pressure being lower than 60 mmHg
timeFrame: within 15 minutes after anesthesia induction
measure: The area under the curve of the mean arterial pressure being lower than 50 mmHg
timeFrame: within 15 minutes after anesthesia induction
measure: The area under the curve of the mean arterial pressure being lower than 40 mmHg
timeFrame: within 15 minutes after anesthesia induction
measure: The duration during which the Mean Arterial Pressure (MAP) is less than 65 mmHg
timeFrame: within 15 minutes after anesthesia induction
measure: The duration during which the Mean Arterial Pressure (MAP) is less than 60 mmHg
timeFrame: within 15 minutes after anesthesia induction
measure: The duration during which the Mean Arterial Pressure (MAP) is less than 50 mmHg
timeFrame: within 15 minutes after anesthesia induction
measure: The duration during which the Mean Arterial Pressure (MAP) is less than 40 mmHg
timeFrame: within 15 minutes after anesthesia induction
measure: The usage of vasoactive drugs
timeFrame: within 15 minutes after anesthesia induction and during the whole process of the surgery
measure: The lowest mean arterial pressure
timeFrame: within 15 minutes after anesthesia induction
measure: the postoperative complications
timeFrame: within 30 days after surgery
measure: the postoperative recovery
timeFrame: on postoperative day 1
measure: Length of hospital stay after surgery
timeFrame: through study completion, an average of 3-15 days
measure: The time duration required to complete endotracheal intubation
timeFrame: through study completion, an average of 10-60 s
measure: The incidence of refractory hypotension
timeFrame: within 15 minutes after anesthesia induction
measure: The number of attempts at tracheal intubation
timeFrame: through study completion, an average of 1-2times
measure: The dosage of propofol during the anesthesia induction period
timeFrame: within 15 minutes after anesthesia induction
measure: The dosage of remifentanil during the anesthesia induction period
timeFrame: within 15 minutes after anesthesia induction
measure: The VIDIAC score of the video laryngoscope.
timeFrame: through study completion, an average of -1~1 points
measure: The usage of other medications during the anesthesia induction period
timeFrame: within 15 minutes after anesthesia induction
measure: The area under the curve of the mean arterial pressure being lower than 65 mmHg
timeFrame: within 20 minutes after anesthesia induction
measure: The pulse pressure variation rate after mechanical ventilation.
timeFrame: At the 1st, 3rd, 5th and 10th minutes after tracheal intubation
measure: The peak airway pressure after mechanical ventilation.
timeFrame: At the 1st minutes after tracheal intubation
measure: The infusion volume of crystalloid solution during the induction period.
timeFrame: within 15 minutes after anesthesia induction
measure: Arterial systolic pressure after anesthesia induction
timeFrame: 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.
measure: Arterial diastolic pressure after anesthesia induction
timeFrame: 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.
measure: Mean arterial pressure after anesthesia induction
timeFrame: 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.
measure: Heart rate after anesthesia induction
timeFrame: 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.
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang cancer hospital
state: Zhejiang
Study officials:
References: