Effects of Steroids, Controlling Blood Sugar Levels, and Avoidance of Deep Anesthesia on Patient Outcomes After Major Vascular Surgery - Full Text View

Sponsors and Collaborators:	Aspect Medical Systems The Cleveland Clinic
Information provided by:	Aspect Medical Systems
ClinicalTrials.gov Identifier:	NCT00433251

Purpose

The perioperative period is characterized by an intense inflammatory response marked by elevated concentrations of inflammatory markers like C-reactive protein (CRP). This response has been linked to increased perioperative morbidity and mortality. Available evidence suggests that blunting the inflammatory response to surgery might improve perioperative outcomes. The benefits from blunting the surgical stress response are likely to be greatest in the high risk patient such as those having major non-cardiac surgery.

Condition	Intervention
Major Non-Cardiac Surgery	Procedure: intensive glucose management Procedure: deeper anesthetic management Drug: placebo Drug: Dexamethasone Drug: conventional glucose control Device: Lighter anesthesia group

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Official Title:	The Effects of Corticosteroids, Glucose Control, and Depth-of-Anesthesia on Perioperative Inflammation and Morbidity From Major Vascular Surgery

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia Nausea and Vomiting Surgery

Drug Information available for: Dexamethasone Dextrose Dexamethasone acetate Doxiproct plus Dexamethasone Sodium Phosphate Corticosteroids

U.S. FDA Resources

Further study details as provided by Aspect Medical Systems:

Primary Outcome Measures:

To test the hypothesis that major perioperative morbidity is reduced by: 1. low dose dexamethasone 2. intensive perioperative glucose control 3. lighter anesthesia [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence and rate of minor surgical complications [ Time Frame: one year ] [ Designated as safety issue: No ]
Reduction in Postoperative nausea and vomiting (PONV) [ Time Frame: post op period ] [ Designated as safety issue: No ]
reduction in the incidence of Postoperative delirium [ Time Frame: duration of hospital admission ] [ Designated as safety issue: No ]
Time to hospital discharge [ Time Frame: duration of hospital admission ] [ Designated as safety issue: No ]
Postoperative quality of life and all-cause one-year mortality [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment:	970
Study Start Date:	February 2007
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator Patients are randomized to either dexamethasone or comparable volume of placebo that will be given intravenously	Drug: placebo comparable volume of placebo will be given IV
Dexamethasone: Experimental	Drug: placebo comparable volume of placebo will be given IV Drug: Dexamethasone 8 mg given 1-2 hours before surgery; 4 mg first POD a.m. and 2 mg on 2nd postop day a.m.
tight glucose control: Experimental blood glucose concentration 80-110 mg/dl	Procedure: intensive glucose management blood glucose 80-110 mg/dl
conventional glucose control: Active Comparator 180-200 mg/dl	Drug: conventional glucose control 180-200 mg/dl
deeper anesthesia: Active Comparator depth of anesthesia will be BIS titrated to <35	Procedure: deeper anesthetic management Titrate Sevoflurane to BIS <35 as hemodynamics permit; fentanyl is allowed per clinical judgement; Guidance for Hemodynamic management is offered within protocol
Lighter Anesthesia group: Experimental Depth of anesthesia will be BIS titrated to near 55.	Device: Lighter anesthesia group BIS titrated sevoflurane anesthesia with BIS near 55; Hemodynamic pertubations as per protocol guidance and clinical judgement; Propofol bolus may be administered; Fentanyl is allowed

Detailed Description:

We will study three interventions potentially modulating perioperative inflammation, corticosteroids, tight glucose control and light anesthesia and their effects on major morbidity and mortality resulting from major non-cardiac surgery.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age >=40 years old
Scheduled for major non-cardiac surgical procedures scheduled to take > or = 2 hours under general anesthesia
Written informed consent

Exclusion Criteria:

Procedures done under regional anesthesia
Non-English speaking patients
Recent Intravenous or oral steroid therapy (within 30 days;inhaled steroids are permitted
Any contraindications to the proposed intervention
ASA physical status >4

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00433251

Contacts

Contact: Nancy Grahm, B.A.,CCRP	216-445-7530	GRAHAMN@CCF.ORG
Contact: Paul J Manberg, PhD		pmanberg@aspectms.com

Locations

United States, Ohio
Cleveland Clinic Foundation	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Nancy Grahm, B.A., CCRP 216-445-7530 GRAHAMN@CCF.ORG
Principal Investigator: Basem Abdelmalak, MD

Sponsors and Collaborators

Aspect Medical Systems

The Cleveland Clinic

Investigators

Study Chair:	Daniel I Sessler, MD	The Cleveland Clinic
Principal Investigator:	Basem Abdelmalak, MD	The Cleveland Clinic

More Information

No publications provided

Responsible Party:	Cleveland Clinic Outcomes Research Division of surgery ( Basem Abdelmalak )
Study ID Numbers:	235
Study First Received:	February 7, 2007
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00433251 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Aspect Medical Systems:

Cleveland Clinic
vascular surgery
intra-operative glucose management
post surgical outcomes
CRP
PONV

post operative delirium
depth of anesthesia
corticosteroids
mortality
Patients scheduled for elective major non-cardiac surgery

Study placed in the following topic categories:

Anti-Inflammatory Agents
Dexamethasone
Fentanyl
Antineoplastic Agents, Hormonal
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Anesthetics
Central Nervous System Depressants
Antiemetics

Glucocorticoids
Hormones
Inflammation
Sevoflurane
Peripheral Nervous System Agents
Propofol
Dexamethasone acetate
Delirium

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dexamethasone
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Anesthetics
Central Nervous System Depressants

Antiemetics
Glucocorticoids
Hormones
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 02, 2009