Hypotension During SurgeryTAPHNCT07328958
Effect of Titrated Administration of Ciprofol on Perioperative Hypotension in Elderly Patients Undergoing Laparoscopic Abdominal Surgery: A Randomized Controlled Trial
A study testing titrated anesthesia in people with Hypotension During Surgery, run by Sixth Affiliated Hospital, Sun Yat-sen University at 2 sites in China.
Trial summary
Elderly patients are frequently burdened with age-associated comorbidities and frailty, accompanied by physiological changes such as vascular stiffening, cardiac dysfunction, and impaired autonomic regulation. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypotension During Surgery
- What is being tested?
- titrated anesthesia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesChina
- Study dates
- 16 Jan 2026to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥65 years, scheduled for elective laparoscopic abdominal surgery
- American Society of Anesthesiologists (ASA) physical status I-III
- Requirement for invasive arterial blood pressure monitoring
Who cannot join
- Participation in other clinical trials that may interfere with the intervention or outcomes of this study
- Severe hepatic or renal disease (GFR ≤30 mL/min/1.73 m², requirement for renal replacement therapy, or Child-Pugh class C liver function)
- Uncontrolled severe hypertension (preoperative SBP ≥180 mmHg or DBP ≥110 mmHg)
- Patients with severe mental disorders (such as schizophrenia), epilepsy, or Parkinson's disease, severe cognitive or intellectual impairment, severe visual or hearing impairments affecting assessment, or long-term alcohol abuse or use of sedative/analgesic medications;
- Known allergy to drugs used in this study
- Requirement for continuous vasopressor infusion before surgery, or intraoperative need for prolonged hemodynamic manipulation due to surgical factors
Show all 9Show fewer
- Anticipated blood loss >15% of estimated blood volume
- Expected surgical duration <1 hours or >6 hours
- Expected postoperative hospital stay <72 hours
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
- Recruiting
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
Hong Bai, slowwind.b@gmail.com
About this study
Official title: Effect of Titrated Administration of Ciprofol Combined With Remifentanil on Perioperative Hypotension in Elderly Patients Undergoing Laparoscopic Abdominal Surgery: A Randomized Controlled Trial
Elderly patients are frequently burdened with age-associated comorbidities and frailty, accompanied by physiological changes such as vascular stiffening, cardiac dysfunction, and impaired autonomic regulation. These factors not only increase the risk of adverse perioperative outcomes but also heighten sensitivity to anesthetic agents, making elderly patients particularly susceptible to anesthesia-related complications, especially hypotension. Consequently, optimizing anesthesia strategies for this high-risk population has become a critical goal in perioperative management.
Titrated anesthesia, which individualizes anesthetic drug delivery based on patient response to achieve predefined endpoints, offers a potential approach to mitigating anesthetic risks. Ciprofol, a novel intravenous anesthetic, has been associated with less hemodynamic suppression compared with traditional agents; however, higher single doses may still predispose patients to hypotension. Remifentanil, an ultra-short-acting opioid, exerts significant cardiovascular depressive effects, further contributing to perioperative hypotension.
It is hypothesized that titrated administration of anesthetic agents during both the induction and maintenance phases, compared with conventional fixed-dose protocols, may reduce the incidence of perioperative hypotension in elderly patients.
Read the detailed description
This study aims to investigate whether titrated anesthesia can provide more stable hemodynamic conditions during surgery and whether this approach is associated with improved postoperative recovery in elderly patients.
- Conditions
- Hypotension During Surgery
- Being tested
- titrated anesthesia
- Keywords
- elderly, general anesthesia, titrated, ciprofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
titrated anesthesiaDrug
Anesthesia induction and maintenance will be performed with ciprofol and remifentanil. During the entire procedure, infusion rates will be adjusted according to a target BIS value of approximately 50, with anesthetic dosing continuously modified in response to BIS monitoring. The attending anesthesiologist will titrate anesthetic delivery based on BIS guidance rather than routine clinical judgment alone.
| Study group | Role | What they receive |
|---|---|---|
| controled group | No intervention | Patients in this group will undergo anesthesia induction and maintenance with ciprofol and remifentanil. Induction will be performed with intravenous bolus administration of ciprofol at a dose of 0.4 mg/kg and remifentanil at a dose of 1.2μg/kg, followed by a neuromuscular blocker to facilitate tracheal intubation. During surgery, anesthetic doses will be adjusted at the discretion of the anesthesiologist, based on the patient's physiological parameters and surgical conditions. BIS monitoring is applied and the screen remains visible to the anesthesiologist. However, ciprofol dose adjustments are made according to routine clinical judgement without reference to a prespecified BIS target or structured titration rule. |
| titrated group | Experimental | In this group, anesthesia induction is performed with continuous infusion of ciprofol until loss of consciousness (OAA/S score = 1). Remifentanil 1.2 μg/kg is then administered, followed by a neuromuscular blocker to facilitate tracheal intubation. After intubation, anesthesia was maintained with ciprofol (0.4-3 mg/kg/h) and remifentanil (0.01-0.5 µg/kg/min) until the end of surgery. Depth of anesthesia was adjusted intraoperatively to maintain BIS at approximately 50. Receives: Drug: titrated anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intraoperative hypotension.
Hypotension is defined as at least one episode of mean arterial pressure (MAP) <65 mmHg sustained for at least 1 minute.
Measured: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
Secondary outcomes (15)
the time-weighted area under the curve (TWA) for MAP <65 mmHg during the anesthesia period
calculated as AUC / total time of anesthesia
Measured: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
cumulative dose of norepinephrine and the proportion of patients requiring vasoactive support;
the cumulative dose of norepinephrine administered intraoperatively (µg) and the proportion of patients who required any vasoactive medication (norepinephrine, dopamine, or ephedrine) during the anesthesia period.
Measured: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
the time-weighted area under the curve (TWA) for MAP <0.8 baseline during the anesthesia period
caculate as area under the curve / total anesthesia time
Measured: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
Time to first hypotension
The time to first hypotension during anesthesia
Measured: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
CI trend during anesthesia
CI data will be collected by the device and extracted for analysis.
Measured: From induction of general anesthesia to the beginning of surgery, assessed intraoperatively for up to 2 hours.
The time periods with a higher incidence of hypotension between the two groups
The time is divided into four parts: induction period, post-induction period, surgical period, and early postoperative period
Measured: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
Total dose of ciprofol and remifentanil during surgery
The total doses of ciprofol and remifentanil administered per hour throughout the entire surgical procedure.
Measured: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
Whether blood pressure variability (CV) and the average rate of blood pressure variation (ARV) are different.
Both CV and ARV will be calculated using the formulas provided in the reference literature.
Measured: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
The incidence of severe intraoperative hypotension
Severe intraoperative hypotension is defined as MAP < 55 mmHg
Measured: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
Time from discontinuation of anesthetic drugs to awakening.
Awakening is defined as the first eye opening in response to a verbal command.
Measured: From discontinuation of anesthetic drugs to awakening, assessed up to 2 hours postoperatively.
the rate of postoperative delirium
Postoperative delirium is assessed using the Chinese version of the 3D-CAM scale. The Chinese version of the 3D-CAM has a sensitivity ranging from 84.6% to 87.2% and a specificity ranging from 96.7% to 97.4%. If a patient is admitted to the ICU, the CAM-ICU scale will be used to evaluate them for delirium.
Measured: Postoperatively (4-6 hours), Day 1, Day 2, Day 3
Postoperative complications
The evaluation of postoperative complications will be conducted using Futier's classification system for postoperative complications, with the primary basis for assessment being medical record data and follow-up data.
Measured: 30 days after the operation
All-cause mortality within 30 days after surgery.
All-cause mortality is defined as death from any cause occurring within 30 days following surgery.
Measured: 30 days after operation
Hospital readmission within 30 days after surgery
Readmission is defined as any unplanned hospital admission occurring within 30 days after surgery.
Measured: 30 days postoperatively.
The lowest MAP during anesthesia
The lowest MAP during anesthesia
Measured: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start16 Jan 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Hypotension During SurgeryStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SanQing Jin, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07328958
- Sponsor's protocol ID
- 2025ZSLYEC-415
- Acronym
- TAPH
- Status last verified
- Apr 2026
- First submitted
- 21 Nov 2025
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cannon JW. Hemorrhagic Shock. N Engl J Med. 2018 Jan 25;378(4):370-379. doi: 10.1056/NEJMra1705649. No abstract available.
PubMed 29365303Dell-Kuster S, Gomes NV, Gawria L, Aghlmandi S, Aduse-Poku M, Bissett I, Blanc C, Brandt C, Ten Broek RB, Bruppacher HR, Clancy C, Delrio P, Espin E, Galanos-Demiris K, Gecim IE, Ghaffari S, Gie O, Goebel B, Hahnloser D, Herbst F, Ioannidis O, Joller S, Kang S, Martin R, Mayr J, Meier S, Murugesan J, Nally D, Ozcelik M, Pace U, Passeri M, Rabanser S, Ranter B, Rega D, Ridgway PF, Rosman C, Schmid R, Schumacher P, Solis-Pena A, Villarino L, Vrochides D, Engel A, O'Grady G, Loveday B, Steiner LA, Van Goor H, Bucher HC, Clavien PA, Kirchhoff P, Rosenthal R. Prospective validation of classification of intraoperative adverse events (ClassIntra): international, multicentre cohort study. BMJ. 2020 Aug 25;370:m2917. doi: 10.1136/bmj.m2917.
PubMed 32843333Lu Z, Zheng H, Chen Z, Xu S, Chen S, Mi W, Wang T, Chai X, Guo Q, Zhou H, Yu Y, Zheng X, Zhang J, Ai Y, Yu B, Bao H, Zheng H, Huang W, Wu A, Deng X, Ma H, Ma W, Tao L, Yang X, Zhang J, Liu T, Ma HP, Liang W, Wang X, Zhang Y, Du W, Ma T, Xie Y, Xie Y, Li N, Yang Y, Zheng T, Zhang C, Zhao Y, Dong R, Zhang C, Zhang G, Liu K, Wu Y, Fan X, Tan W, Li N, Dong H, Xiong L. Effect of Etomidate vs Propofol for Total Intravenous Anesthesia on Major Postoperative Complications in Older Patients: A Randomized Clinical Trial. JAMA Surg. 2022 Oct 1;157(10):888-895. doi: 10.1001/jamasurg.2022.3338.
PubMed 35947398Futier E, Lefrant JY, Guinot PG, Godet T, Lorne E, Cuvillon P, Bertran S, Leone M, Pastene B, Piriou V, Molliex S, Albanese J, Julia JM, Tavernier B, Imhoff E, Bazin JE, Constantin JM, Pereira B, Jaber S; INPRESS Study Group. Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1346-1357. doi: 10.1001/jama.2017.14172.
PubMed 28973220Wildes TS, Mickle AM, Ben Abdallah A, Maybrier HR, Oberhaus J, Budelier TP, Kronzer A, McKinnon SL, Park D, Torres BA, Graetz TJ, Emmert DA, Palanca BJ, Goswami S, Jordan K, Lin N, Fritz BA, Stevens TW, Jacobsohn E, Schmitt EM, Inouye SK, Stark S, Lenze EJ, Avidan MS; ENGAGES Research Group. Effect of Electroencephalography-Guided Anesthetic Administration on Postoperative Delirium Among Older Adults Undergoing Major Surgery: The ENGAGES Randomized Clinical Trial. JAMA. 2019 Feb 5;321(5):473-483. doi: 10.1001/jama.2018.22005.
PubMed 30721296Salmasi V, Maheshwari K, Yang D, Mascha EJ, Singh A, Sessler DI, Kurz A. Relationship between Intraoperative Hypotension, Defined by Either Reduction from Baseline or Absolute Thresholds, and Acute Kidney and Myocardial Injury after Noncardiac Surgery: A Retrospective Cohort Analysis. Anesthesiology. 2017 Jan;126(1):47-65. doi: 10.1097/ALN.0000000000001432.
PubMed 27792044Maheshwari K, Turan A, Mao G, Yang D, Niazi AK, Agarwal D, Sessler DI, Kurz A. The association of hypotension during non-cardiac surgery, before and after skin incision, with postoperative acute kidney injury: a retrospective cohort analysis. Anaesthesia. 2018 Oct;73(10):1223-1228. doi: 10.1111/anae.14416. Epub 2018 Aug 24.
PubMed 30144029D'Souza AW, Hissen SL, Manabe K, Takeda R, Washio T, Coombs GB, Sanchez B, Fu Q, Shoemaker JK. Age- and sex-related differences in sympathetic vascular transduction and neurohemodynamic balance in humans. Am J Physiol Heart Circ Physiol. 2023 Oct 1;325(4):H917-H932. doi: 10.1152/ajpheart.00301.2023. Epub 2023 Aug 18.
PubMed 37594483Abdellatif M, Rainer PP, Sedej S, Kroemer G. Hallmarks of cardiovascular ageing. Nat Rev Cardiol. 2023 Nov;20(11):754-777. doi: 10.1038/s41569-023-00881-3. Epub 2023 May 16.
PubMed 37193857Brauer D. [Evaluation of medical data using statistics software: the program packet ABSTAT]. Z Arztl Fortbild (Jena). 1988;82(18):905-8. No abstract available. German.
PubMed 3213092
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Titrated Administration of Ciprofol Combined With Remifentanil on Perioperative Hypotension in Elderly Patients Undergoing Laparoscopic Abdominal Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07328958
- Acronym / sponsor ID
- TAPH / 2025ZSLYEC-415
- Conditions
- Hypotension During Surgery
- Keywords
- elderly, general anesthesia, titrated, ciprofol
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 9 Jan 2026 (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.
Elderly patients are frequently burdened with age-associated comorbidities and frailty, accompanied by physiological changes such as vascular stiffening, cardiac dysfunction, and impaired autonomic regulation. These factors not only increase the risk of adverse perioperative outcomes but also heighten sensitivity to anesthetic agents, making elderly patients particularly susceptible to anesthesia-related complications, especially hypotension. Consequently, optimizing anesthesia strategies for this high-risk population has become a critical goal in perioperative management.
Titrated anesthesia, which individualizes anesthetic drug delivery based on patient response to achieve predefined endpoints, offers a potential approach to mitigating anesthetic risks. Ciprofol, a novel intravenous anesthetic, has been associated with less hemodynamic suppression compared with traditional agents; however, higher single doses may still predispose patients to hypotension. Remifentanil, an ultra-short-acting opioid, exerts significant cardiovascular depressive effects, further contributing to perioperative hypotension.
It is hypothesized that titrated administration of anesthetic agents during both the induction and maintenance phases, compared with conventional fixed-dose protocols, may reduce the incidence of perioperative hypotension in elderly patients.
Detailed description
This study aims to investigate whether titrated anesthesia can provide more stable hemodynamic conditions during surgery and whether this approach is associated with improved postoperative recovery in elderly patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| controled group | No intervention | –Patients in this group will undergo anesthesia induction and maintenance with ciprofol and remifentanil. Induction will be performed with intravenous bolus administration of ciprofol at a dose of 0.4 mg/kg and remifentanil at a dose of 1.2μg/kg, followed by a neuromuscular blocker to facilitate tracheal intubation. During surgery, anesthetic doses will be adjusted at the discretion of the anesthesiologist, based on the patient's physiological parameters and surgical conditions. BIS monitoring is applied and the screen remains visible to the anesthesiologist. However, ciprofol dose adjustments are made according to routine clinical judgement without reference to a prespecified BIS target or structured titration rule. |
| titrated group | Experimental | Drug: titrated anesthesiaIn this group, anesthesia induction is performed with continuous infusion of ciprofol until loss of consciousness (OAA/S score = 1). Remifentanil 1.2 μg/kg is then administered, followed by a neuromuscular blocker to facilitate tracheal intubation. After intubation, anesthesia was maintained with ciprofol (0.4-3 mg/kg/h) and remifentanil (0.01-0.5 µg/kg/min) until the end of surgery. Depth of anesthesia was adjusted intraoperatively to maintain BIS at approximately 50. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age ≥65 years, scheduled for elective laparoscopic abdominal surgery
- American Society of Anesthesiologists (ASA) physical status I-III
- Requirement for invasive arterial blood pressure monitoring
Key exclusion criteria (9 listed)
- Participation in other clinical trials that may interfere with the intervention or outcomes of this study
- Severe hepatic or renal disease (GFR ≤30 mL/min/1.73 m², requirement for renal replacement therapy, or Child-Pugh class C liver function)
- Uncontrolled severe hypertension (preoperative SBP ≥180 mmHg or DBP ≥110 mmHg)
- Patients with severe mental disorders (such as schizophrenia), epilepsy, or Parkinson's disease, severe cognitive or intellectual impairment, severe visual or hearing impairments affecting assessment, or long-term alcohol abuse or use of sedative/analgesic medications;
- Known allergy to drugs used in this study
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 |
|---|---|---|
| titrated anesthesiaAnesthesia induction and maintenance will be performed with ciprofol and remifentanil. During the entire procedure, infusion rates will be adjusted according to a target BIS value of approximately 50, with anesthetic dosing continuously modified in response to BIS monitoring. The attending anesthesiologist will titrate anesthetic delivery based on BIS guidance rather than routine clinical judgment alone. | Drug | titrated group |
Primary outcome
Incidence of intraoperative hypotension.
Time frame: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
Hypotension is defined as at least one episode of mean arterial pressure (MAP) <65 mmHg sustained for at least 1 minute.
15 secondary outcomes
the time-weighted area under the curve (TWA) for MAP <65 mmHg during the anesthesia period
Time frame: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
cumulative dose of norepinephrine and the proportion of patients requiring vasoactive support;
Time frame: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
the time-weighted area under the curve (TWA) for MAP <0.8 baseline during the anesthesia period
Time frame: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
Time to first hypotension
Time frame: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
CI trend during anesthesia
Time frame: From induction of general anesthesia to the beginning of surgery, assessed intraoperatively for up to 2 hours.
The time periods with a higher incidence of hypotension between the two groups
Time frame: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
Total dose of ciprofol and remifentanil during surgery
Time frame: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
Whether blood pressure variability (CV) and the average rate of blood pressure variation (ARV) are different.
Time frame: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
The incidence of severe intraoperative hypotension
Time frame: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
Time from discontinuation of anesthetic drugs to awakening.
Time frame: From discontinuation of anesthetic drugs to awakening, assessed up to 2 hours postoperatively.
the rate of postoperative delirium
Time frame: Postoperatively (4-6 hours), Day 1, Day 2, Day 3
Postoperative complications
Time frame: 30 days after the operation
All-cause mortality within 30 days after surgery.
Time frame: 30 days after operation
Hospital readmission within 30 days after surgery
Time frame: 30 days postoperatively.
The lowest MAP during anesthesia
Time frame: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Background: PubMed 29365303Cannon JW. Hemorrhagic Shock. N Engl J Med. 2018 Jan 25;378(4):370-379. doi: 10.1056/NEJMra1705649. No abstract available.
- Background: PubMed 32843333Dell-Kuster S, Gomes NV, Gawria L, Aghlmandi S, Aduse-Poku M, Bissett I, Blanc C, Brandt C, Ten Broek RB, Bruppacher HR, Clancy C, Delrio P, Espin E, Galanos-Demiris K, Gecim IE, Ghaffari S, Gie O, Goebel B, Hahnloser D, Herbst F, Ioannidis O, Joller S, Kang S, Martin R, Mayr J, Meier S, Murugesan J, Nally D, Ozcelik M, Pace U, Passeri M, Rabanser S, Ranter B, Rega D, Ridgway PF, Rosman C, Schmid R, Schumacher P, Solis-Pena A, Villarino L, Vrochides D, Engel A, O'Grady G, Loveday B, Steiner LA, Van Goor H, Bucher HC, Clavien PA, Kirchhoff P, Rosenthal R. Prospective validation of classification of intraoperative adverse events (ClassIntra): international, multicentre cohort study. BMJ. 2020 Aug 25;370:m2917. doi: 10.1136/bmj.m2917.
- Background: PubMed 35947398Lu Z, Zheng H, Chen Z, Xu S, Chen S, Mi W, Wang T, Chai X, Guo Q, Zhou H, Yu Y, Zheng X, Zhang J, Ai Y, Yu B, Bao H, Zheng H, Huang W, Wu A, Deng X, Ma H, Ma W, Tao L, Yang X, Zhang J, Liu T, Ma HP, Liang W, Wang X, Zhang Y, Du W, Ma T, Xie Y, Xie Y, Li N, Yang Y, Zheng T, Zhang C, Zhao Y, Dong R, Zhang C, Zhang G, Liu K, Wu Y, Fan X, Tan W, Li N, Dong H, Xiong L. Effect of Etomidate vs Propofol for Total Intravenous Anesthesia on Major Postoperative Complications in Older Patients: A Randomized Clinical Trial. JAMA Surg. 2022 Oct 1;157(10):888-895. doi: 10.1001/jamasurg.2022.3338.
- Background: PubMed 28973220Futier E, Lefrant JY, Guinot PG, Godet T, Lorne E, Cuvillon P, Bertran S, Leone M, Pastene B, Piriou V, Molliex S, Albanese J, Julia JM, Tavernier B, Imhoff E, Bazin JE, Constantin JM, Pereira B, Jaber S; INPRESS Study Group. Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1346-1357. doi: 10.1001/jama.2017.14172.
- Background: PubMed 30721296Wildes TS, Mickle AM, Ben Abdallah A, Maybrier HR, Oberhaus J, Budelier TP, Kronzer A, McKinnon SL, Park D, Torres BA, Graetz TJ, Emmert DA, Palanca BJ, Goswami S, Jordan K, Lin N, Fritz BA, Stevens TW, Jacobsohn E, Schmitt EM, Inouye SK, Stark S, Lenze EJ, Avidan MS; ENGAGES Research Group. Effect of Electroencephalography-Guided Anesthetic Administration on Postoperative Delirium Among Older Adults Undergoing Major Surgery: The ENGAGES Randomized Clinical Trial. JAMA. 2019 Feb 5;321(5):473-483. doi: 10.1001/jama.2018.22005.
- Background: PubMed 27792044Salmasi V, Maheshwari K, Yang D, Mascha EJ, Singh A, Sessler DI, Kurz A. Relationship between Intraoperative Hypotension, Defined by Either Reduction from Baseline or Absolute Thresholds, and Acute Kidney and Myocardial Injury after Noncardiac Surgery: A Retrospective Cohort Analysis. Anesthesiology. 2017 Jan;126(1):47-65. doi: 10.1097/ALN.0000000000001432.
- Background: PubMed 30144029Maheshwari K, Turan A, Mao G, Yang D, Niazi AK, Agarwal D, Sessler DI, Kurz A. The association of hypotension during non-cardiac surgery, before and after skin incision, with postoperative acute kidney injury: a retrospective cohort analysis. Anaesthesia. 2018 Oct;73(10):1223-1228. doi: 10.1111/anae.14416. Epub 2018 Aug 24.
- Background: PubMed 37594483D'Souza AW, Hissen SL, Manabe K, Takeda R, Washio T, Coombs GB, Sanchez B, Fu Q, Shoemaker JK. Age- and sex-related differences in sympathetic vascular transduction and neurohemodynamic balance in humans. Am J Physiol Heart Circ Physiol. 2023 Oct 1;325(4):H917-H932. doi: 10.1152/ajpheart.00301.2023. Epub 2023 Aug 18.
- Background: PubMed 37193857Abdellatif M, Rainer PP, Sedej S, Kroemer G. Hallmarks of cardiovascular ageing. Nat Rev Cardiol. 2023 Nov;20(11):754-777. doi: 10.1038/s41569-023-00881-3. Epub 2023 May 16.
- Background: PubMed 3213092Brauer D. [Evaluation of medical data using statistics software: the program packet ABSTAT]. Z Arztl Fortbild (Jena). 1988;82(18):905-8. No abstract available. German.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing titrated anesthesia in people with Hypotension During Surgery, run by Sixth Affiliated Hospital, Sun Yat-sen University at 2 sites 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 3 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hong Bai, Doctoral student (+86 13480250519, bhong@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of intraoperative hypotension. (time frame: From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07328958, which also lists 10 linked publications.
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 10 Jun 2026.