Hypotension on Induction, Old Age
Conditions
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.
Interventions
After the loss of consciousness during general anesthesia, the 10° Trendelenburg position is adopted.
OTHERSupine Horizontal Position
After the loss of consciousness during general anesthesia, the Supine Horizontal Position is adopted.
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The area under the curve of the mean arterial pressure being lower than 65 mmHg | within 15 minutes after anesthesia induction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 40 mmHg | within 15 minutes after anesthesia induction | — |
| The usage of vasoactive drugs | 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. |
| The lowest mean arterial pressure | within 15 minutes after anesthesia induction | — |
| the postoperative complications | within 30 days after surgery | The complications are assessed using the Claviene-Dindo score. |
| the postoperative recovery | 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. |
| 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 | within 15 minutes after anesthesia induction | If either of the following two definitions is met, it is considered refractory hypotension: 1. 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). 2. 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. |
| The duration during which the Mean Arterial Pressure (MAP) is less than 50 mmHg | within 15 minutes after anesthesia induction | — |
| 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. | 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. |
| The usage of other medications during the anesthesia induction period | within 15 minutes after anesthesia induction | The usage of medications other than propofol, remifentanil, phenylephrine, ephedrine, norepinephrine, and epinephrine. |
| 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 | 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. |
| Arterial diastolic pressure 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. | The monitor records continuous arterial blood pressure data at intervals of 1 second. |
| Mean arterial pressure 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. | The monitor records continuous arterial blood pressure data at intervals of 1 second. |
| 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. | — |
| The number of attempts at tracheal intubation | through study completion, an average of 1-2times | — |
Countries
China
Contacts
Primary ContactJi Zhu
Outcome results
None listed