Hypotension on InductionNCT06968091
Effect of Trendelenburg Positioning on Anesthesia-Induced Hypotension in Elderly Patients
A study testing Trendelenburg position and Supine Horizontal Position in people with Hypotension on Induction and Old Age, run by Zhejiang Cancer Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Hypotension on Induction, Old Age
- What is being tested?
- Trendelenburg position and Supine Horizontal Position
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- 16 May 2025to 3 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Trendelenburg Positioning on Anesthesia-Induced Hypotension in Elderly Patients: A Randomized Controlled Clinical Trial
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
- Being tested
- Trendelenburg position, Supine Horizontal Position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trendelenburg positionOther
After the loss of consciousness during general anesthesia, the 10° Trendelenburg position is adopted.
Supine Horizontal PositionOther
After the loss of consciousness during general anesthesia, the Supine Horizontal Position is adopted.
| Study group | Role | What they receive |
|---|---|---|
| The Trendelenburg Position Group | Experimental | Not described Receives: Other: Trendelenburg position |
| The Supine Horizontal Position Group | Placebo comparator | Not described Receives: Other: Supine Horizontal Position |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area under the curve of the mean arterial pressure being lower than 65 mmHg
Measured: within 15 minutes after anesthesia induction
Secondary outcomes (27)
The area under the curve of the mean arterial pressure being lower than 60 mmHg
Measured: within 15 minutes after anesthesia induction
The area under the curve of the mean arterial pressure being lower than 50 mmHg
Measured: within 15 minutes after anesthesia induction
The area under the curve of the mean arterial pressure being lower than 40 mmHg
Measured: within 15 minutes after anesthesia induction
The duration during which the Mean Arterial Pressure (MAP) is less than 65 mmHg
Measured: within 15 minutes after anesthesia induction
The duration during which the Mean Arterial Pressure (MAP) is less than 60 mmHg
Measured: within 15 minutes after anesthesia induction
The duration during which the Mean Arterial Pressure (MAP) is less than 50 mmHg
Measured: within 15 minutes after anesthesia induction
The duration during which the Mean Arterial Pressure (MAP) is less than 40 mmHg
Measured: 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.
Measured: within 15 minutes after anesthesia induction and during the whole process of the surgery
The lowest mean arterial pressure
Measured: within 15 minutes after anesthesia induction
the postoperative complications
The complications are assessed using the Claviene-Dindo score.
Measured: 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.
Measured: on postoperative day 1
Length of hospital stay after surgery
Measured: through study completion, an average of 3-15 days
The time duration required to complete endotracheal intubation
Measured: 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:
- 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.
Measured: within 15 minutes after anesthesia induction
The number of attempts at tracheal intubation
Measured: through study completion, an average of 1-2times
The dosage of propofol during the anesthesia induction period
Measured: within 15 minutes after anesthesia induction
The dosage of remifentanil during the anesthesia induction period
Measured: 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.
Measured: 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.
Measured: within 15 minutes after anesthesia induction
The area under the curve of the mean arterial pressure being lower than 65 mmHg
Measured: within 20 minutes after anesthesia induction
The pulse pressure variation rate after mechanical ventilation.
Measured: At the 1st, 3rd, 5th and 10th minutes after tracheal intubation
The peak airway pressure after mechanical ventilation.
Measured: At the 1st minutes after tracheal intubation
The infusion volume of crystalloid solution during the induction period.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start16 May 2025
- Primary completion1 Apr 2026
- Study completion3 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension on InductionStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gu Bin, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968091
- Sponsor's protocol ID
- IRB-2025-478
- Status last verified
- Apr 2026
- First submitted
- 3 May 2025
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share data on ClinicalTrials.gov, and data sharing will be always available.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Trendelenburg Positioning on Anesthesia-Induced Hypotension in Elderly Patients: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06968091
- Acronym / sponsor ID
- IRB-2025-478
- Conditions
- Hypotension on Induction, Old Age
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 16 May 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 3 Apr 2026 (actual)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Trendelenburg Position Group | Experimental | Other: Trendelenburg position |
| The Supine Horizontal Position Group | Placebo comparator | Other: Supine Horizontal Position |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trendelenburg positionAfter the loss of consciousness during general anesthesia, the 10° Trendelenburg position is adopted. | Other | The Trendelenburg Position Group |
| Supine Horizontal PositionAfter the loss of consciousness during general anesthesia, the Supine Horizontal Position is adopted. | Other | The Supine Horizontal Position Group |
Primary outcome
The area under the curve of the mean arterial pressure being lower than 65 mmHg
Time frame: within 15 minutes after anesthesia induction
27 secondary outcomes
The area under the curve of the mean arterial pressure being lower than 60 mmHg
Time frame: within 15 minutes after anesthesia induction
The area under the curve of the mean arterial pressure being lower than 50 mmHg
Time frame: within 15 minutes after anesthesia induction
The area under the curve of the mean arterial pressure being lower than 40 mmHg
Time frame: within 15 minutes after anesthesia induction
The duration during which the Mean Arterial Pressure (MAP) is less than 65 mmHg
Time frame: within 15 minutes after anesthesia induction
The duration during which the Mean Arterial Pressure (MAP) is less than 60 mmHg
Time frame: within 15 minutes after anesthesia induction
The duration during which the Mean Arterial Pressure (MAP) is less than 50 mmHg
Time frame: within 15 minutes after anesthesia induction
The duration during which the Mean Arterial Pressure (MAP) is less than 40 mmHg
Time frame: within 15 minutes after anesthesia induction
The usage of vasoactive drugs
Time frame: within 15 minutes after anesthesia induction and during the whole process of the surgery
The lowest mean arterial pressure
Time frame: within 15 minutes after anesthesia induction
the postoperative complications
Time frame: within 30 days after surgery
the postoperative recovery
Time frame: on postoperative day 1
Length of hospital stay after surgery
Time frame: through study completion, an average of 3-15 days
The time duration required to complete endotracheal intubation
Time frame: through study completion, an average of 10-60 s
The incidence of refractory hypotension
Time frame: within 15 minutes after anesthesia induction
The number of attempts at tracheal intubation
Time frame: through study completion, an average of 1-2times
The dosage of propofol during the anesthesia induction period
Time frame: within 15 minutes after anesthesia induction
The dosage of remifentanil during the anesthesia induction period
Time frame: within 15 minutes after anesthesia induction
The VIDIAC score of the video laryngoscope.
Time frame: through study completion, an average of -1~1 points
The usage of other medications during the anesthesia induction period
Time frame: within 15 minutes after anesthesia induction
The area under the curve of the mean arterial pressure being lower than 65 mmHg
Time frame: within 20 minutes after anesthesia induction
The pulse pressure variation rate after mechanical ventilation.
Time frame: At the 1st, 3rd, 5th and 10th minutes after tracheal intubation
The peak airway pressure after mechanical ventilation.
Time frame: At the 1st minutes after tracheal intubation
The infusion volume of crystalloid solution during the induction period.
Time frame: within 15 minutes after anesthesia induction
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: Yes. We will share data on ClinicalTrials.gov, and data sharing will be always available.
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Anesthesia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trendelenburg position and Supine Horizontal Position in people with Hypotension on Induction and Old Age, run by Zhejiang Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The area under the curve of the mean arterial pressure being lower than 65 mmHg (time frame: within 15 minutes after anesthesia induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.