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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The Trendelenburg Position Group | Experimental |
| |
| The Supine Horizontal Position Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trendelenburg position | Other | After the loss of consciousness during general anesthesia, the 10° Trendelenburg position is adopted. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The area under the curve of the mean arterial pressure being lower than 65 mmHg | within 15 minutes after anesthesia induction |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang cancer hospital | Hangzhou | Zhejiang | China |
We will share data on ClinicalTrials.gov, and data sharing will be always available.
starting about 6 months after publication
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| ID | Term |
|---|---|
| D018475 | Head-Down Tilt |
| ID | Term |
|---|---|
| D011187 | Posture |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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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.
| Supine Horizontal Position | Other | After the loss of consciousness during general anesthesia, the Supine Horizontal Position is adopted. |
|
| 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 |
| The duration during which the Mean Arterial Pressure (MAP) is less than 50 mmHg | within 15 minutes after anesthesia induction |
| The duration during which the Mean Arterial Pressure (MAP) is less than 40 mmHg | within 15 minutes after anesthesia induction |
| The usage of vasoactive drugs | The vasoactive drugs are selected from the following according to the protocol: phenylephrine, ephedrine, norepinephrine, and epinephrine. | within 15 minutes after anesthesia induction and during the whole process of the surgery |
| The lowest mean arterial pressure | within 15 minutes after anesthesia induction |
| the postoperative complications | The complications are assessed using the Claviene-Dindo score. | within 30 days after surgery |
| the postoperative recovery | 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. | on postoperative day 1 |
| Length of hospital stay after surgery | through study completion, an average of 3-15 days |
| The time duration required to complete endotracheal intubation | through study completion, an average of 10-60 s |
| The incidence of refractory hypotension | If either of the following two definitions is met, it is considered refractory hypotension:
| within 15 minutes after anesthesia induction |
| The number of attempts at tracheal intubation | through study completion, an average of 1-2times |
| The dosage of propofol during the anesthesia induction period | within 15 minutes after anesthesia induction |
| The dosage of remifentanil during the anesthesia induction period | within 15 minutes after anesthesia induction |
| The VIDIAC score of the video laryngoscope. | 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. | through study completion, an average of -1~1 points |
| The usage of other medications during the anesthesia induction period | The usage of medications other than propofol, remifentanil, phenylephrine, ephedrine, norepinephrine, and epinephrine. | within 15 minutes after anesthesia induction |
| The area under the curve of the mean arterial pressure being lower than 65 mmHg | within 20 minutes after anesthesia induction |
| The pulse pressure variation rate after mechanical ventilation. | At the 1st, 3rd, 5th and 10th minutes after tracheal intubation |
| The peak airway pressure after mechanical ventilation. | At the 1st minutes after tracheal intubation |
| The infusion volume of crystalloid solution during the induction period. | within 15 minutes after anesthesia induction |
| Arterial systolic pressure after anesthesia induction | The monitor records continuous arterial blood pressure data at intervals of 1 second. | 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. |
| Arterial diastolic pressure after anesthesia induction | The monitor records continuous arterial blood pressure data at intervals of 1 second. | 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. |
| Mean arterial pressure after anesthesia induction | The monitor records continuous arterial blood pressure data at intervals of 1 second. | 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. |
| Heart rate after anesthesia induction | 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. |