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

August 15, 2016 updated by: Hu Anmin

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

322

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518001
        • Recruiting
        • ShenZhen People's Hospital
        • Contact:
        • Principal Investigator:
          • Gong Xiaolei, M.S
        • Principal Investigator:
          • Zhang Zhongjun, M.S
        • Sub-Investigator:
          • Li Furong, Ph.D
        • Sub-Investigator:
          • Qiu Chen, M.D
    • Guizhou
      • Guiyang, Guizhou, China, 550000
        • Recruiting
        • The Affiliated Hospital of Guizhou Medical University
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • Henan Provincial People's Hospital
        • Contact:
    • Hubei
      • Shiyan, Hubei, China, 442000
        • Recruiting
        • Taihe Hospital affiliated to Hubei University of Medicine
        • Contact:
          • Wang Xianyu, M.D
          • Phone Number: 13972482018
          • Email: wxytj@126.com
        • Principal Investigator:
          • Li Shutao, M.D
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • West China Hospital Affiliated to Sichuan University
        • Contact:
      • Chengdu, Sichuan, China, 641000
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China, 650000
        • Recruiting
        • The Third Affiliated Hospital of Kunming Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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:
  • Neosynephrine
  • Metaoxedrin
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 Names:
  • 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:
  • Neosynephrine
  • Metaoxedrin
Procedure: High-level MAP
MAP is regulated to the goal level (90-100 mmHg) during general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of delirium
Time Frame: Within the first 7 days after surgery
Within the first 7 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within the first 7 days after surgery
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.
Intra-operative
Intraoperative urine volume.
Time Frame: Intra-operative
Intra-operative
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.
The investigators would observe it within the 28-day period after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hu Anmin

Collaborators

West China Hospital
Henan Provincial People's Hospital
The Affiliated Hospital Of Guizhou Medical University
Sichuan Provincial People's Hospital
Taihe Hospital
The Third Affiliated Hospital of Kunming Medical College.

Investigators

  • Study Director: Hu Anmin, Jinan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

July 15, 2016

First Submitted That Met QC Criteria

August 2, 2016

First Posted (Estimate)

August 5, 2016

Study Record Updates

Last Update Posted (Estimate)

August 16, 2016

Last Update Submitted That Met QC Criteria

August 15, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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