Intraoperative Goal-directed Blood Pressure and Dexmedetomidine
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03933306 |
|
Recruitment Status :
Active, not recruiting
First Posted : May 1, 2019
Last Update Posted : February 4, 2021
|
Sponsor:
Peking University First Hospital
Information provided by (Responsible Party):
Dong-Xin Wang, Peking University First Hospital
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Blood Pressure Dexmedetomidine High-risk Patients Abdominal Surgery Postoperative Complications | Drug: Dexmedetomidine Drug: Placebo Other: Goal-directed blood pressure management Other: Routine blood pressure management | Phase 4 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 496 participants |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| Intervention Model Description: | This is a 2x2 factorial trial |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Masking Description: | For dexmedetomidine infusion, all the participants, care providers, investigators, outcomes assessors are masked. For blood pressure management, care providers, namely anesthesiologists, are not masked. |
| Primary Purpose: | Prevention |
| 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 |
| Actual Study Start Date : | May 20, 2019 |
| Actual Primary Completion Date : | October 29, 2020 |
| Estimated Study Completion Date : | May 2023 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Dexmedetomidine
| Arm | Intervention/treatment |
|---|---|
|
Placebo Comparator: Placebo+routine blood pressure management
Placebo (normal saline) is administered during anesthesia. Blood pressure is managed according to routine practice.
|
Drug: Placebo
Loading dose placebo administered before anesthesia induction, followed by a continuous infusion until 1 hour before the end of surgery.
Other Name: Normal saline Other: Routine blood pressure management 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. |
|
Experimental: Dexmedetomidine+routine blood pressure management
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.
|
Drug: Dexmedetomidine
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.
Other Name: Dexmedetomidine hydrochloride injection Other: Routine blood pressure management 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. |
|
Experimental: Placebo+goal-directed blood pressure management
Placebo (normal saline) is administered during anesthesia. Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management.
|
Drug: Placebo
Loading dose placebo administered before anesthesia induction, followed by a continuous infusion until 1 hour before the end of surgery.
Other Name: Normal saline Other: Goal-directed blood pressure management Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management. |
|
Experimental: Dexmedetomidine+goal-directed blood pressure management
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.
|
Drug: Dexmedetomidine
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.
Other Name: Dexmedetomidine hydrochloride injection Other: Goal-directed blood pressure management Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management. |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- Incidence of organ injury and other complications within 7 days after surgery. [ Time Frame: Up to 7 days after surgery. ]A composite endpoint including delirium, acute kidney injury, myocardial injury, and other complications after surgery.
- Length of stay in the intensive care unit after surgery. [ Time Frame: Up to 30 days after surgery. ]Length of stay in the intensive care unit after surgery.
- Length of stay in hospital after surgery. [ Time Frame: Up to 30 days after surgery. ]Length of stay in hospital after surgery.
- 30-day all-cause mortality. [ Time Frame: Up to 30 days after surgery. ]Rate of death due to any cause within 30 days after surgery.
- Overall survival within 2 years after surgery. [ Time Frame: Up to 2 years after surgery. ]Overall survival within 2 years after surgery.
- Disease-free survival within 2 years after surgery. [ Time Frame: Up to 2 years after surgery. ]Disease-free survival within 2 years after surgery.
- Quality of life of 2-year survivors: WHOQOL-BREF [ Time Frame: At the end of 2 years after surgery. ]Quality of life is assessed with with the World Health Organization quality of life scale brief version (WHOQOL-BREF).
- Cognition function of 2-year survivors. [ Time Frame: At the end of 2 years after surgery. ]Cognitive function is assessed with the Telephone Interview for Cognitive Status-Modified (TICS-m).
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03933306
Locations
| China, Beijing | |
| Peking University First Hospital | |
| Beijing, Beijing, China, 100034 | |
Sponsors and Collaborators
Peking University First Hospital
Investigators
| Principal Investigator: | Dong-Xin Wang, MD, PhD | Peking University First Hospital |
Publications:
| Responsible Party: | Dong-Xin Wang, Professor and Chairman, Department of Anaesthesiology and Critical Care Medicine, Peking University First Hospital |
| ClinicalTrials.gov Identifier: | NCT03933306 |
| Other Study ID Numbers: |
2019-73 |
| First Posted: | May 1, 2019 Key Record Dates |
| Last Update Posted: | February 4, 2021 |
| Last Verified: | February 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Dong-Xin Wang, Peking University First Hospital:
|
blood pressure management dexmedetomidine high-risk patients abdominal surgery postoperative organ injury |
Additional relevant MeSH terms:
|
Postoperative Complications Pathologic Processes Dexmedetomidine Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |