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Effect of High vs. Low MAP Levels on Clinical Outcomes in Elderly Patients During Noncardiothoracic Surgery

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ClinicalTrials.gov Identifier: NCT02857153
Recruitment Status : Recruiting
First Posted : August 5, 2016
Last Update Posted : August 16, 2016
Sponsor:
Collaborators:
West China Hospital
The Affiliated Hospital Of Guizhou Medical University
Taihe Hospital
The Third Affiliated Hospital of Kunming Medical College.
Sichuan Provincial People's Hospital
Henan Provincial Hospital
Information provided by (Responsible Party):
Hu Anmin, The Second Clinical Medical College of Jinan University

Brief Summary:
This will be a multicentre, randomised, controlled and prospective clinical trial. All participants provided their written informed consent to participate in a randomized trial that examined the effects of low-level MAP (60-70 mmHg) vs. high-level MAP (90-100 mmHg) in elderly patients (65 or more years of age) during noncardiothoracic surgery under general anesthesia. The investigators hypothesise high-level blood presure of the intervention for reducing the incidence of post-operative complications.

Condition or disease Intervention/treatment Phase
Aging Surgery Blood Pressure Anesthesia Blood Loss, Surgical Postoperative Delirium Drug: Urapidil Drug: Phenylephrine Procedure: Low-level MAP Procedure: High-level MAP Not Applicable

Detailed Description:

This will be a multicentre, randomised, controlled and prospective clinical trial. Elderly patients will be included from seven centers, including Shenzhen People's Hospital affiliated to Jinan University, West China Hospital affiliated to Sichuan University, Taihe Hospital affiliated to Hubei University of Medicine, The Third Affiliated Hospital of Kunming Medical University, Sichuan Provincial People's Hospital, Guizhou Provincial People's Hospital and Henan Provincial People's Hospital. This research protocol was approved by the Institutional Review Board of Jinan University (2016001).

On the day of surgery, patients come to the operating room and are provided with standard monitoring. General anesthesia is given using midazolam and propofol, opioids, muscle relaxants and maintained with sevoflurane with inhaled concentrations of 1.5% sevoflurane in oxygen. Supplemental dosing of 1 μg/kg of fentanyl is used every hour from induction up to approximately 1 hour prior to the end of surgery. A tramadol bolus of 2 mg/kg is given 15 to 30 mins before the end of surgery. Propofol infusion is stopped 5 to 10 mins prior to the end of surgery, whereas at the end of skin closure, remifentanil was discontinued.

According to grouping, MAP is regulated to the goal level (60-70 mmHg or 95-100 mmHg) during general anesthesia. If necessary, intravenous antihypertensives (urapidil or phenylephrine when mean arterial pressure exceeded 10 mmHg of the target value), rather than more anesthesia, may be used in situations wherein sympathetic stimulation was high; yet a sufficient amount of anesthesia was being administered and bispectral index showed an adequate depth of hypnosis. Sedation was provided by a propofol infusion targeted to a BIS number of approximately 50 during general anesthesia. Atropine and esmolol would be used at the time of heart rate <50 beats/min and >110 beats/min, respectively.

Lactated Ringer's solution was given to bring the maintenance fluids to 10 ml/kg/h. Blood loss could be corrected for in a 1:1 ratio using gelofusine. Hospital transfusion guidelines were used to determine whether blood products were necessary (haemoglobin level less than 10 g/dl in patients with cardiac comorbidities, and below 7 g.dl-1 in those without cardiac disease). For later starting cases, an additional bolus of Ringer's solution of 1.5 ml/kg/fasted hour from 8 AM was given to bring the total 2 ml/kg/fasted hour. If urine output decreased to <0.5 mL/kg/h for 1 hour, fursemide 0.3 mg/kg was given.

Mechanical ventilation patterns are adjusted to obtain an end-tidal carbon dioxide value of 35-45 mmHg, at 5-10 min after induction of anesthesia.

For patients with endotracheal tubes, intravenous sedatives including propofol or midazolam were administrated continuously and titrated by bedside nurses to a target sedation level. Daily awakening is used for those who were not extubated in the morning.

All patients receive patient controlled intravenous analgesia during postoperative days 1 to 3.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 322 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparsion of the Effect of High Versus Low Mean Arterial Pressure (MAP) Levels on Clinical Outcomes in Elderly Patients During Noncardiothoracic Surgery Under General Anesthesia
Study Start Date : July 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

Arm Intervention/treatment
Experimental: Low-level MAP
According to grouping, MAP is regulated to the goal level (60-70 mmHg) during general anesthesia.
Drug: Urapidil
If necessary, intravenous urapidil 0.2-0.5 mg/kg when mean arterial pressure exceeded 10 mmHg of the target value, rather than more anesthesia, may be used in situations wherein sympathetic stimulation was high; yet a sufficient amount of anesthesia was being administered and bispectral index showed an adequate depth of hypnosis. Sedation was provided by a propofol infusion targeted to a BIS number of approximately 50 during general anesthesia.
Other Name: Ebrantil

Drug: Phenylephrine
If necessary, intravenous phenylephrine 4-6 μg/kg when mean arterial pressure exceeded 10 mmHg of the target value, rather than more anesthesia, may be used in situations wherein sympathetic stimulation was high; yet a sufficient amount of anesthesia was being administered and bispectral index showed an adequate depth of hypnosis. Sedation was provided by a propofol infusion targeted to a BIS number of approximately 50 during general anesthesia.
Other Names:
  • Metaoxedrin
  • Neosynephrine

Procedure: Low-level MAP
MAP is regulated to the goal level (60-70 mmHg) during general anesthesia.

Experimental: High-level MAP
According to grouping, MAP is regulated to the goal level (90-100 mmHg) during general anesthesia.
Drug: Urapidil
If necessary, intravenous urapidil 0.2-0.5 mg/kg when mean arterial pressure exceeded 10 mmHg of the target value, rather than more anesthesia, may be used in situations wherein sympathetic stimulation was high; yet a sufficient amount of anesthesia was being administered and bispectral index showed an adequate depth of hypnosis. Sedation was provided by a propofol infusion targeted to a BIS number of approximately 50 during general anesthesia.
Other Name: Ebrantil

Drug: Phenylephrine
If necessary, intravenous phenylephrine 4-6 μg/kg when mean arterial pressure exceeded 10 mmHg of the target value, rather than more anesthesia, may be used in situations wherein sympathetic stimulation was high; yet a sufficient amount of anesthesia was being administered and bispectral index showed an adequate depth of hypnosis. Sedation was provided by a propofol infusion targeted to a BIS number of approximately 50 during general anesthesia.
Other Names:
  • Metaoxedrin
  • Neosynephrine

Procedure: High-level MAP
MAP is regulated to the goal level (90-100 mmHg) during general anesthesia.




Primary Outcome Measures :
  1. Incidence of delirium [ Time Frame: Within the first 7 days after surgery ]

Secondary Outcome Measures :
  1. Delirium duration days (Postoperative delirium defined by the confusion assessment method for the ICU (CAM-ICU)) [ Time Frame: Within the first 7 days after surgery ]
  2. Intra-operative blood loss [ Time Frame: Intra-operative ]
    Estimate of blood loss occurring during the surgical procedure as determined by anesthesia staff and documented by anesthesia, nursing and surgical staff as per hospital protocol.

  3. Intraoperative urine volume. [ Time Frame: Intra-operative ]
  4. All-cause 28-day mortality. [ Time Frame: The investigators would observe it within the 28-day period after surgery. ]
    Outcome assessment will be performed by independent researchers.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male and females, American Society of Anesthesiologists I-II-III, 65 or more years of age, scheduled to undergo noncardiothoracic surgery with general anesthesia are enrolled.

Exclusion Criteria:

  • the patient suffered from Cardiovascular Disease and Metabolic Diseases, such as hypertension, cardiac disease, diabetes;
  • the patient has severe liver, kidney or blood disease;
  • the patient is accompanied severe cognitive impairment (Mini-Mental State Examination (MMSE) score < 15);
  • preoperative history of schizophrenia, epilepsy, parkinsonism, use of cholinesterase inhibitor, or levodopa treatment;
  • use of haloperidol or other neuroleptics during or after anesthesia;
  • neurosurgery;
  • individuals unlikely to survive for >24 hrs; previous participation in this study.

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): NCT02857153


Contacts
Contact: Hu Anmin 18026980789 toanmin@163.com

Locations
China, Guangdong
Shenzhen People's Hospital Recruiting
Shenzhen, Guangdong, China, 518001
Contact: Hu Anmin, M.S    18026980789    toanmin@163.com   
Principal Investigator: Gong Xiaolei, M.S         
Principal Investigator: Zhang Zhongjun, M.S         
Sub-Investigator: Li Furong, Ph.D         
Sub-Investigator: Qiu Chen, M.D         
China, Guizhou
The affiliated Hospital of Guizhou Medical University Recruiting
Guiyang, Guizhou, China, 550000
Contact: Hu Bolong, M.S       375896605@qq.com   
China, Henan
Henan Provincial People's Hospital Recruiting
Zhengzhou, Henan, China, 450000
Contact: Yang Yali, M.S    18703818071    yangyali_1982@163.com   
China, Hubei
Taihe Hospital affiliated to Hubei University of Medicine Recruiting
Shiyan, Hubei, China, 442000
Contact: Wang Xianyu, M.D    13972482018    wxytj@126.com   
Principal Investigator: Li Shutao, M.D         
China, Sichuan
West China Hospital affiliated to Sichuan University Recruiting
Chengdu, Sichuan, China, 610000
Contact: Qiu Yan, M.S    18980606269    12395299@qq.com   
Sichuan Provincial People's Hospital Recruiting
Chengdu, Sichuan, China, 641000
Contact: Zhang Peng, Ph.D    15902891950    583559085@qq.com   
China, Yunnan
The Third Affiliated Hospital of Kunming Medical University Recruiting
Kunming, Yunnan, China, 650000
Contact: Zhao Rui, M.S    18388231643    635741914@qq.com   
Sponsors and Collaborators
Hu Anmin
West China Hospital
The Affiliated Hospital Of Guizhou Medical University
Taihe Hospital
The Third Affiliated Hospital of Kunming Medical College.
Sichuan Provincial People's Hospital
Henan Provincial Hospital
Investigators
Study Director: Hu Anmin Jinan University

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hu Anmin, Shenzhen People's Hospital, The Second Clinical Medical College of Jinan University
ClinicalTrials.gov Identifier: NCT02857153     History of Changes
Other Study ID Numbers: 2016001
First Posted: August 5, 2016    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Hu Anmin, The Second Clinical Medical College of Jinan University:
MAP
Blood loss
Postoperative delirium
Elderly patients
Noncardiothoracic surgery

Additional relevant MeSH terms:
Antihypertensive Agents
Delirium
Hemorrhage
Blood Loss, Surgical
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Pathologic Processes
Intraoperative Complications
Anesthetics
Phenylephrine
Oxymetazoline
Urapidil
Central Nervous System Depressants
Physiological Effects of Drugs
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists