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

Surgery Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02857153
• Other study ID #: 2016001
• Status: Recruiting
• Phase: N/A
• First received: July 15, 2016
• Last updated: August 15, 2016
• Start date: July 2016
• Est. completion date: October 2017

Study information

• Verified date: August 2016
• Source: The Second Clinical Medical College of Jinan University
• Contact: Hu Anmin
• Phone: 18026980789
• Email: toanmin[@]163.com
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 322
• Est. completion date: October 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aging
• Anesthesia
• Blood Loss, Surgical
• Blood Pressure
• Delirium
• Hemorrhage
• Postoperative Delirium
• Surgery

Intervention

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.
• 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.

Procedure:
• Low-level MAP
MAP is regulated to the goal level (60-70 mmHg) during general anesthesia.
• High-level MAP
MAP is regulated to the goal level (90-100 mmHg) during general anesthesia.

Locations

Country	Name	City	State
China	Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	West China Hospital affiliated to Sichuan University	Chengdu	Sichuan
China	The affiliated Hospital of Guizhou Medical University	Guiyang	Guizhou
China	The Third Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	Shenzhen People's Hospital	Shenzhen	Guangdong
China	Taihe Hospital affiliated to Hubei University of Medicine	Shiyan	Hubei
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (7)

Lead Sponsor	Collaborator
Hu Anmin	Henan Provincial Hospital, Sichuan Provincial People's Hospital, Taihe Hospital, The Affiliated Hospital Of Guizhou Medical University, The Third Affiliated Hospital of Kunming Medical College., West China Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. Anesthesi — View Citation

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 conte — View Citation

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. Anest — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of delirium		Within the first 7 days after surgery	Yes
Secondary	Delirium duration days (Postoperative delirium defined by the confusion assessment method for the ICU (CAM-ICU))		Within the first 7 days after surgery	Yes
Secondary	Intra-operative blood loss	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	Yes
Secondary	Intraoperative urine volume.		Intra-operative	Yes
Secondary	All-cause 28-day mortality.	Outcome assessment will be performed by independent researchers.	The investigators would observe it within the 28-day period after surgery.	Yes