Blood PressurePhase 4NCT03933306

Intraoperative Goal-directed Blood Pressure and Dexmedetomidine on Outcomes

A Phase 4 study testing Dexmedetomidine, Goal-directed blood pressure management and Routine blood pressure management in people with Blood Pressure and Dexmedetomidine, run by Peking University First Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 50 years and older
Conditions the study is for: Blood Pressure, Dexmedetomidine, High-risk Patients
What is being tested?: Dexmedetomidine, Goal-directed blood pressure management and Routine blood pressure management
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 496 participants
Where: 1 siteChina
Study dates: 20 May 2019to 30 May 2024
Phase: Phase 4
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 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 50 years or older;
Scheduled to undergo abdominal surgery under general anesthesia with an expected duration of 2 hours or longer;
With a preoperative acute kidney injury risk index of class III or higher (meet 4 or more of the following factors: age ≥56 years, male sex, active congestive heart failure, ascites, hypertension, emergency surgery, intraperitoneal surgery, mild or moderate renal insuffificiency, diabetes mellitus requiring oral or insulin therapy).

Who cannot join

Severe uncontrolled hypertension (SBP>180 mmHg or diastolic blood pressure >110 mmHg);
Acute or decompensated heart failure, acute coronary syndrome, or stroke within 1 month;
Severe bradycardia (heart rate < 50 bpm), sick sinus syndrome, second-degree or higher atrioventricular block without pacemaker, atrial fibrillation, or frequent premature beats;
Severe hepatic dysfunction (Child-Pugh C) or chronic kidney disease (glomerular filtration rate <30 ml/min/1.73 m2 or dependent on renal replacement therapy) ;
Pregnant;
Receiving dexmedetomidine or norepinephrine infusion before surgery;
Do not provide written informed consent.

Trial locations and contacts

1 site in 1 country.

China1 site

Peking University First Hospital
Beijing, Beijing Municipality, 100034

Other trials in China

About this study

Official title: Impact of Intraoperative Goal-directed Blood Pressure Management and Dexmedetomidine on Outcomes of High-risk Patients After Major Abdominal Surgeries: a 2×2 Factorial Randomized Controlled Trial

Perioperative organ injuriy remain an important threat to patients undergoing major surgeries. Intraoperative hypotension is associated with an increase in postoperative morbidity and mortality. Whereas individualized intraoperative blood pressure management is likely to decrease the incidence of postoperative organ injury when compared with standard blood pressure management strategy. Dexmedetomidine, a highly selective alpha2 adrenergic agonist, has been shown to provide organ protective effects. This study aims to investigate the impact of intraoperative goal-directed blood pressure management and dexmedetomidine infusion on incidence of postoperative organ injury in high-risk patients undergoing major surgery.

Read the detailed description

The number of patients undergoing surgeries is increasing worldwide. However, some patients develop complications or even die after surgery. Perioperative organ injury is the leading cause of the unfavorable outcomes.

Hypotension is not uncommon during major surgery and is highly responsible for the inadequate perfusion and organ injury. A recent study showed that individualized blood pressure management decreases the incidence of postoperative organ injury when compared with standard blood pressure management strategy.

Dexmedetomidine is a highly selective alpha2 adrenergic agonist. Previous studies showed that dexmedetomidine provides organ protection in various conditions. In a recent meta-analysis, perioperative dexmedetomidine reduceds the occurrence of postoperative delirium. However, whether it can reduce postoperative complications remains inconclusive.

This study aims to investigate the impact of intraoperative goal-directed blood pressure management and dexmedetomidine infusion on the incidence of postoperative organ injury in high-risk patients undergoing major abdominal surgery.

Conditions: Blood Pressure, Dexmedetomidine, High-risk Patients, Abdominal Surgery, Postoperative Complications
Being tested: Dexmedetomidine, Placebo, Goal-directed blood pressure management, Routine blood pressure management
Keywords: blood pressure management, dexmedetomidine, high-risk patients, abdominal surgery, postoperative organ injury
Medical subject headings: Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DexmedetomidineDrug
Also called Dexmedetomidine hydrochloride injection
Loading dose dexmedetomidine (0.6 mcg/kg for 10 min) administered before anesthesia induction, followed by a continuous infusion (0.5 mcg/kg/h) until 1 hour before the end of surgery.
PlaceboDrug
Also called Normal saline
Loading dose placebo administered before anesthesia induction, followed by a continuous infusion until 1 hour before the end of surgery.
Goal-directed blood pressure managementOther
Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management.
Routine blood pressure managementOther
Blood pressure is maintained according to routine practice, i.e., systolic blood pressure > 90 mmHg or within ±30% of baseline within intermittent ephedrine or phenylephrine.

Study groups in NCT03933306
Study group	Role	What they receive
Placebo+routine blood pressure management	Placebo comparator	Placebo (normal saline) is administered during anesthesia. Blood pressure is managed according to routine practice. Receives: Drug: Placebo; Other: Routine blood pressure management
Dexmedetomidine+routine blood pressure management	Experimental	Dexmedetomidine is administered during anesthesia (0.6 mcg/kg for 10 min, then 0.5 mcg/kg/h). Blood pressure is managed according to routine practice. Receives: Drug: Dexmedetomidine; Other: Routine blood pressure management
Placebo+goal-directed blood pressure management	Experimental	Placebo (normal saline) is administered during anesthesia. Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management. Receives: Drug: Placebo; Other: Goal-directed blood pressure management
Dexmedetomidine+goal-directed blood pressure management	Experimental	Dexmedetomidine is administered during anesthesia (0.6 mcg/kg for 10 min, then 0.5 mcg/kg/h). Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management. Receives: Drug: Dexmedetomidine; Other: Goal-directed blood pressure management

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of organ injury and other complications within 30 days after surgery.
A composite endpoint including delirium, acute kidney injury, myocardial injury, and other complications after surgery.
Measured: Up to 30 days after surgery.

Secondary outcomes (8)

Incidence of organ injury and other complications within 7 days after surgery.
A composite endpoint including delirium, acute kidney injury, myocardial injury, and other complications after surgery.
Measured: Up to 7 days after surgery.
Length of stay in the intensive care unit after surgery.
Length of stay in the intensive care unit after surgery.
Measured: Up to 30 days after surgery.
Length of stay in hospital after surgery.
Length of stay in hospital after surgery.
Measured: Up to 30 days after surgery.
30-day all-cause mortality.
Rate of death due to any cause within 30 days after surgery.
Measured: Up to 30 days after surgery.
Overall survival after surgery.
Overall survival after surgery.
Measured: Up to 3 years after surgery.
Disease-free survival after surgery.
Disease-free survival after surgery.
Measured: Up to 3 years after surgery.
Quality of life of 3-year survivors: WHOQOL-BREF
Quality of life is assessed with with the World Health Organization quality of life scale brief version (WHOQOL-BREF).
Measured: At the end of 3 years after surgery.
Cognition function of 3-year survivors.
Cognitive function is assessed with the Telephone Interview for Cognitive Status-Modified (TICS-m).
Measured: At the end of 3 years after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 May 201930 May 2024

First posted1 May 2019
Study start20 May 2019
Primary completion29 Oct 2020
Study completion30 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (32)Papers the sponsor has linked to this study.
Other trials for Blood PressureStudies of the same condition, open and under way.
More trials run by Peking University First 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 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Model description: This is a 2x2 factorial trial
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 496 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03933306
Sponsor's protocol ID: 2019-73
Status last verified: Jul 2025
First submitted: 27 Apr 2019
Last updated: 18 Jul 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Weiser TG, Haynes AB, Molina G, Lipsitz SR, Esquivel MM, Uribe-Leitz T, Fu R, Azad T, Chao TE, Berry WR, Gawande AA. Estimate of the global volume of surgery in 2012: an assessment supporting improved health outcomes. Lancet. 2015 Apr 27;385 Suppl 2:S11. doi: 10.1016/S0140-6736(15)60806-6. Epub 2015 Apr 26.
PubMed 26313057
Monk TG, Bronsert MR, Henderson WG, Mangione MP, Sum-Ping ST, Bentt DR, Nguyen JD, Richman JS, Meguid RA, Hammermeister KE. Association between Intraoperative Hypotension and Hypertension and 30-day Postoperative Mortality in Noncardiac Surgery. Anesthesiology. 2015 Aug;123(2):307-19. doi: 10.1097/ALN.0000000000000756.
PubMed 26083768
Sessler DI, Meyhoff CS, Zimmerman NM, Mao G, Leslie K, Vasquez SM, Balaji P, Alvarez-Garcia J, Cavalcanti AB, Parlow JL, Rahate PV, Seeberger MD, Gossetti B, Walker SA, Premchand RK, Dahl RM, Duceppe E, Rodseth R, Botto F, Devereaux PJ. Period-dependent Associations between Hypotension during and for Four Days after Noncardiac Surgery and a Composite of Myocardial Infarction and Death: A Substudy of the POISE-2 Trial. Anesthesiology. 2018 Feb;128(2):317-327. doi: 10.1097/ALN.0000000000001985.
PubMed 29189290
Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.
PubMed 23835589
Sun LY, Wijeysundera DN, Tait GA, Beattie WS. Association of intraoperative hypotension with acute kidney injury after elective noncardiac surgery. Anesthesiology. 2015 Sep;123(3):515-23. doi: 10.1097/ALN.0000000000000765.
PubMed 26181335
Wesselink EM, Kappen TH, Torn HM, Slooter AJC, van Klei WA. Intraoperative hypotension and the risk of postoperative adverse outcomes: a systematic review. Br J Anaesth. 2018 Oct;121(4):706-721. doi: 10.1016/j.bja.2018.04.036. Epub 2018 Jun 20.
PubMed 30236233
Futier 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 28973220
Memis D, Hekimoglu S, Vatan I, Yandim T, Yuksel M, Sut N. Effects of midazolam and dexmedetomidine on inflammatory responses and gastric intramucosal pH to sepsis, in critically ill patients. Br J Anaesth. 2007 Apr;98(4):550-2. doi: 10.1093/bja/aem017. No abstract available.
PubMed 17363413
Xiang H, Hu B, Li Z, Li J. Dexmedetomidine controls systemic cytokine levels through the cholinergic anti-inflammatory pathway. Inflammation. 2014 Oct;37(5):1763-70. doi: 10.1007/s10753-014-9906-1.
PubMed 24803295
Cho JS, Kim HI, Lee KY, An JY, Bai SJ, Cho JY, Yoo YC. Effect of Intraoperative Dexmedetomidine Infusion on Postoperative Bowel Movements in Patients Undergoing Laparoscopic Gastrectomy: A Prospective, Randomized, Placebo-Controlled Study. Medicine (Baltimore). 2015 Jun;94(24):e959. doi: 10.1097/MD.0000000000000959.
PubMed 26091461
Kocoglu H, Karaaslan K, Gonca E, Bozdogan O, Gulcu N. Preconditionin effects of dexmedetomidine on myocardial ischemia/reperfusion injury in rats. Curr Ther Res Clin Exp. 2008 Apr;69(2):150-8. doi: 10.1016/j.curtheres.2008.04.003.
PubMed 24692794
Cheng J, Zhu P, Qin H, Li X, Yu H, Yu H, Peng X. Dexmedetomidine attenuates cerebral ischemia/reperfusion injury in neonatal rats by inhibiting TLR4 signaling. J Int Med Res. 2018 Jul;46(7):2925-2932. doi: 10.1177/0300060518781382. Epub 2018 Jun 21.
PubMed 29926753
Sahin T, Begec Z, Toprak HI, Polat A, Vardi N, Yucel A, Durmus M, Ersoy MO. The effects of dexmedetomidine on liver ischemia-reperfusion injury in rats. J Surg Res. 2013 Jul;183(1):385-90. doi: 10.1016/j.jss.2012.11.034. Epub 2012 Dec 8.
PubMed 23321519
Hanci V, Yurdakan G, Yurtlu S, Turan IO, Sipahi EY. Protective effect of dexmedetomidine in a rat model of alpha-naphthylthiourea-induced acute lung injury. J Surg Res. 2012 Nov;178(1):424-30. doi: 10.1016/j.jss.2012.02.027. Epub 2012 Mar 9.
PubMed 22445456
Kocoglu H, Ozturk H, Ozturk H, Yilmaz F, Gulcu N. Effect of dexmedetomidine on ischemia-reperfusion injury in rat kidney: a histopathologic study. Ren Fail. 2009;31(1):70-4. doi: 10.1080/08860220802546487.
PubMed 19142813

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
Not yet recruiting
Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior

All Blood Pressure trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of Intraoperative Goal-directed Blood Pressure Management and Dexmedetomidine on Outcomes of High-risk Patients After Major Abdominal Surgeries: a 2×2 Factorial Randomized Controlled Trial
ClinicalTrials.gov ID: NCT03933306
Acronym / sponsor ID: 2019-73
Conditions: Blood Pressure, Dexmedetomidine, High-risk Patients, Abdominal Surgery, Postoperative Complications
Keywords: blood pressure management, dexmedetomidine, high-risk patients, abdominal surgery, postoperative organ injury
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 496 participants (actual)
Lead sponsor: Peking University First HospitalUniversity, hospital or other
Study start: 20 May 2019 (actual)
Primary completion: 29 Oct 2020 (actual)
Study completion: 30 May 2024 (actual)
First posted: 1 May 2019 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4
Model description: This is a 2x2 factorial trial

Arm	Type	Receives
Placebo+routine blood pressure management	Placebo comparator	Drug: Placebo, Other: Routine blood pressure managementPlacebo (normal saline) is administered during anesthesia. Blood pressure is managed according to routine practice.
Dexmedetomidine+routine blood pressure management	Experimental	Drug: Dexmedetomidine, Other: Routine blood pressure managementDexmedetomidine is administered during anesthesia (0.6 mcg/kg for 10 min, then 0.5 mcg/kg/h). Blood pressure is managed according to routine practice.
Placebo+goal-directed blood pressure management	Experimental	Drug: Placebo, Other: Goal-directed blood pressure managementPlacebo (normal saline) is administered during anesthesia. Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management.
Dexmedetomidine+goal-directed blood pressure management	Experimental	Drug: Dexmedetomidine, Other: Goal-directed blood pressure managementDexmedetomidine is administered during anesthesia (0.6 mcg/kg for 10 min, then 0.5 mcg/kg/h). Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Age 50 years or older;
Scheduled to undergo abdominal surgery under general anesthesia with an expected duration of 2 hours or longer;
With a preoperative acute kidney injury risk index of class III or higher (meet 4 or more of the following factors: age ≥56 years, male sex, active congestive heart failure, ascites, hypertension, emergency surgery, intraperitoneal surgery, mild or moderate renal insuffificiency, diabetes mellitus requiring oral or insulin therapy).

Key exclusion criteria (7 listed)

Severe uncontrolled hypertension (SBP>180 mmHg or diastolic blood pressure >110 mmHg);
Acute or decompensated heart failure, acute coronary syndrome, or stroke within 1 month;
Severe bradycardia (heart rate < 50 bpm), sick sinus syndrome, second-degree or higher atrioventricular block without pacemaker, atrial fibrillation, or frequent premature beats;
Severe hepatic dysfunction (Child-Pugh C) or chronic kidney disease (glomerular filtration rate <30 ml/min/1.73 m2 or dependent on renal replacement therapy) ;
Pregnant;

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
DexmedetomidineAlso: Dexmedetomidine hydrochloride injectionLoading dose dexmedetomidine (0.6 mcg/kg for 10 min) administered before anesthesia induction, followed by a continuous infusion (0.5 mcg/kg/h) until 1 hour before the end of surgery.	Drug	Dexmedetomidine+goal-directed blood pressure management, Dexmedetomidine+routine blood pressure management
PlaceboAlso: Normal salineLoading dose placebo administered before anesthesia induction, followed by a continuous infusion until 1 hour before the end of surgery.	Drug	Placebo+goal-directed blood pressure management, Placebo+routine blood pressure management
Goal-directed blood pressure managementBlood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management.	Other	Dexmedetomidine+goal-directed blood pressure management, Placebo+goal-directed blood pressure management
Routine blood pressure managementBlood pressure is maintained according to routine practice, i.e., systolic blood pressure > 90 mmHg or within ±30% of baseline within intermittent ephedrine or phenylephrine.	Other	Dexmedetomidine+routine blood pressure management, Placebo+routine blood pressure management

Primary outcome

Incidence of organ injury and other complications within 30 days after surgery.
Time frame: Up to 30 days after surgery.
A composite endpoint including delirium, acute kidney injury, myocardial injury, and other complications after surgery.

8 secondary outcomes

Incidence of organ injury and other complications within 7 days after surgery.
Time frame: Up to 7 days after surgery.
Length of stay in the intensive care unit after surgery.
Time frame: Up to 30 days after surgery.
Length of stay in hospital after surgery.
Time frame: Up to 30 days after surgery.
30-day all-cause mortality.
Time frame: Up to 30 days after surgery.
Overall survival after surgery.
Time frame: Up to 3 years after surgery.
Disease-free survival after surgery.
Time frame: Up to 3 years after surgery.
Quality of life of 3-year survivors: WHOQOL-BREF
Time frame: At the end of 3 years after surgery.
Cognition function of 3-year survivors.
Time frame: At the end of 3 years after surgery.

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 18 Jul 2025.
Background: PubMed 26313057Weiser TG, Haynes AB, Molina G, Lipsitz SR, Esquivel MM, Uribe-Leitz T, Fu R, Azad T, Chao TE, Berry WR, Gawande AA. Estimate of the global volume of surgery in 2012: an assessment supporting improved health outcomes. Lancet. 2015 Apr 27;385 Suppl 2:S11. doi: 10.1016/S0140-6736(15)60806-6. Epub 2015 Apr 26.
Background: PubMed 26083768Monk TG, Bronsert MR, Henderson WG, Mangione MP, Sum-Ping ST, Bentt DR, Nguyen JD, Richman JS, Meguid RA, Hammermeister KE. Association between Intraoperative Hypotension and Hypertension and 30-day Postoperative Mortality in Noncardiac Surgery. Anesthesiology. 2015 Aug;123(2):307-19. doi: 10.1097/ALN.0000000000000756.
Background: PubMed 29189290Sessler DI, Meyhoff CS, Zimmerman NM, Mao G, Leslie K, Vasquez SM, Balaji P, Alvarez-Garcia J, Cavalcanti AB, Parlow JL, Rahate PV, Seeberger MD, Gossetti B, Walker SA, Premchand RK, Dahl RM, Duceppe E, Rodseth R, Botto F, Devereaux PJ. Period-dependent Associations between Hypotension during and for Four Days after Noncardiac Surgery and a Composite of Myocardial Infarction and Death: A Substudy of the POISE-2 Trial. Anesthesiology. 2018 Feb;128(2):317-327. doi: 10.1097/ALN.0000000000001985.
Background: PubMed 23835589Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.
Background: PubMed 26181335Sun LY, Wijeysundera DN, Tait GA, Beattie WS. Association of intraoperative hypotension with acute kidney injury after elective noncardiac surgery. Anesthesiology. 2015 Sep;123(3):515-23. doi: 10.1097/ALN.0000000000000765.
Background: PubMed 30236233Wesselink EM, Kappen TH, Torn HM, Slooter AJC, van Klei WA. Intraoperative hypotension and the risk of postoperative adverse outcomes: a systematic review. Br J Anaesth. 2018 Oct;121(4):706-721. doi: 10.1016/j.bja.2018.04.036. Epub 2018 Jun 20.
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 17363413Memis D, Hekimoglu S, Vatan I, Yandim T, Yuksel M, Sut N. Effects of midazolam and dexmedetomidine on inflammatory responses and gastric intramucosal pH to sepsis, in critically ill patients. Br J Anaesth. 2007 Apr;98(4):550-2. doi: 10.1093/bja/aem017. No abstract available.
Background: PubMed 24803295Xiang H, Hu B, Li Z, Li J. Dexmedetomidine controls systemic cytokine levels through the cholinergic anti-inflammatory pathway. Inflammation. 2014 Oct;37(5):1763-70. doi: 10.1007/s10753-014-9906-1.
Background: PubMed 26091461Cho JS, Kim HI, Lee KY, An JY, Bai SJ, Cho JY, Yoo YC. Effect of Intraoperative Dexmedetomidine Infusion on Postoperative Bowel Movements in Patients Undergoing Laparoscopic Gastrectomy: A Prospective, Randomized, Placebo-Controlled Study. Medicine (Baltimore). 2015 Jun;94(24):e959. doi: 10.1097/MD.0000000000000959.
Background: PubMed 24692794Kocoglu H, Karaaslan K, Gonca E, Bozdogan O, Gulcu N. Preconditionin effects of dexmedetomidine on myocardial ischemia/reperfusion injury in rats. Curr Ther Res Clin Exp. 2008 Apr;69(2):150-8. doi: 10.1016/j.curtheres.2008.04.003.
Background: PubMed 29926753Cheng J, Zhu P, Qin H, Li X, Yu H, Yu H, Peng X. Dexmedetomidine attenuates cerebral ischemia/reperfusion injury in neonatal rats by inhibiting TLR4 signaling. J Int Med Res. 2018 Jul;46(7):2925-2932. doi: 10.1177/0300060518781382. Epub 2018 Jun 21.
Individual participant dataSharing planned: No

Related trials for Blood Pressure

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
Not yet recruiting
Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior

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.

Dong-Xin Wang, MD, PhD principal investigator

Peking University First Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 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 18 Jul 2025. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Incidence of organ injury and other complications within 30 days after surgery. (time frame: Up to 30 days after surgery.). 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 NCT03933306, which also lists 32 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 18 Jul 2025.