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

NCT02857153 | Unknown DMC

• 1 other identifier: 2016001
• Study Type: interventional
• Target: 322
• Locations: 1 country
• Sites: 7

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.

Conditions

Aging; Surgery; Blood Pressure; Anesthesia; Blood Loss, Surgical; Postoperative Delirium

Keywords

MAP; Blood loss; Postoperative delirium; Elderly patients; Noncardiothoracic surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of delirium

  Within the first 7 days after surgery

Secondary Outcomes (4)

• Delirium duration days (Postoperative delirium defined by the confusion assessment method for the ICU (CAM-ICU))

  Within the first 7 days after surgery

• Intra-operative blood loss

  Intra-operative

• Intraoperative urine volume.

  Intra-operative

• All-cause 28-day mortality.

  The investigators would observe it within the 28-day period after surgery.

Study Arms (2)

Low-level MAP

EXPERIMENTAL

According to grouping, MAP is regulated to the goal level (60-70 mmHg) during general anesthesia.

Drug: Urapidil; Drug: Phenylephrine; Procedure: Low-level MAP

High-level MAP

EXPERIMENTAL

According to grouping, MAP is regulated to the goal level (90-100 mmHg) during general anesthesia.

Drug: Urapidil; Drug: Phenylephrine; Procedure: High-level MAP

Interventions

Urapidil DRUG

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.

Also known as: Ebrantil

High-level MAP; Low-level MAP

Phenylephrine DRUG

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.

Also known as: Metaoxedrin, Neosynephrine

High-level MAP; Low-level MAP

Low-level MAP PROCEDURE

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

Low-level MAP

High-level MAP PROCEDURE

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

High-level MAP

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hu Anmin: lead
• West China Hospital: collaborator
• The Affiliated Hospital Of Guizhou Medical University: collaborator
• Taihe Hospital: collaborator
• The Third Affiliated Hospital of Kunming Medical College.: collaborator
• Sichuan Provincial People's Hospital: collaborator
• Henan Provincial People's Hospital: collaborator

Study Sites (7)

Shenzhen People's Hospital

Shenzhen, Guangdong, 518001, China

RECRUITING

The affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, 550000, China

RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

Taihe Hospital affiliated to Hubei University of Medicine

Shiyan, Hubei, 442000, China

RECRUITING

West China Hospital affiliated to Sichuan University

Chengdu, Sichuan, 610000, China

RECRUITING

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 641000, China

RECRUITING

The Third Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650000, China

RECRUITING

Related Publications (6)

• London MJ. Intraoperative Mean Blood Pressure and Outcome: Is 80 (mmHg) the "New" 60? Anesthesiology. 2016 Jan;124(1):4-6. doi: 10.1097/ALN.0000000000000923. No abstract available.

  PMID: 26540150 BACKGROUND

• 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.

  PMID: 26083768 RESULT

• 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.

  PMID: 23835589 RESULT

• Chang HS, Hongo K, Nakagawa H. Adverse effects of limited hypotensive anesthesia on the outcome of patients with subarachnoid hemorrhage. J Neurosurg. 2000 Jun;92(6):971-5. doi: 10.3171/jns.2000.92.6.0971.

  PMID: 10839257 RESULT

• Reich DL, Bennett-Guerrero E, Bodian CA, Hossain S, Winfree W, Krol M. Intraoperative tachycardia and hypertension are independently associated with adverse outcome in noncardiac surgery of long duration. Anesth Analg. 2002 Aug;95(2):273-7, table of contents. doi: 10.1097/00000539-200208000-00003.

  PMID: 12145033 RESULT

• Hu A, Qiu Y, Zhang P, Hu B, Yang Y, Li S, Zhao R, Zhang Z, Zhang Y, Zheng Z, Qiu C, Li F, Gong X. Comparison of the effect of high versus low mean arterial pressure levels on clinical outcomes and complications in elderly patients during non-cardiothoracic surgery under general anesthesia: study protocol for a randomized controlled trial. Trials. 2017 Nov 21;18(1):554. doi: 10.1186/s13063-017-2233-8.

  PMID: 29162132 DERIVED

MeSH Terms

Conditions

Blood Loss, Surgical; Emergence Delirium; Hemorrhage

Interventions

urapidil; Phenylephrine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Hu Anmin

  Jinan University

  STUDY DIRECTOR

Central Study Contacts

Hu Anmin

CONTACT

18026980789; toanmin@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Shenzhen People's Hospital

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: August 5, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: October 1, 2017
• Last Updated: August 16, 2016

Record last verified: 2016-08

Locations

CN (7)