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Effect of Perioperative Glycemia Protocol on Glycemic Outcomes in Diabetic Patients Undergoing Abdominal Surgery

S

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

Status

Completed

Conditions

Perioperative Complication
Hyperglycemia

Treatments

Other: glycaemic management protocol implemented to clinic

Study type

Interventional

Funder types

Other

Identifiers

NCT04167410
SBUniversitesi_nursing

Details and patient eligibility

About

This study evaluated to the effects of a glycaemic control protocol directed by nurses during the perioperative period on glycaemic outcomes in diabetic patients undergoing major abdominal surgery. The study was conducted at the department of general surgery of a research and training hospital.The study included 47 patients who underwent elective major abdominal surgery between September 2017 and December 2018. The number of patients in the intervention and the control groups was 22 and 25, respectively. The glycemia control protocol will be used in the glycemia management of intervention group,routine glycemia management will be used in the control group.

Full description

The prevalence of diabetes among the surgical patient population is 10-15%, and surgical operations are administered to diabetic patients more frequently compared to non-diabetic patients. Diabetes or hyperglycaemia in surgical patients increases mortality and morbidity rates during the perioperative period by 50% compared to non-diabetic patients. Maintaining patient blood glucose (BG) levels of within the target range during the surgical period is crucial to prevent postoperative complications. The target BG level has been modified in line with recent scientific findings; institutions (such as the American Diabetes Association), have prepared new guidelines for the management of glycaemia in critically ill and surgical patients. Insulin infusion is the most effective method to control glycaemia in patients with critical disease or in patients about to undergo major surgery. Therefore, current guidelines recommend the use of reliable and practical glycaemia control protocols during insulin infusion. These protocols should be learnt by all members of the team that provide healthcare. Existing studies suggest that glycaemic management protocols are effective methods to achieve the target BG range and decrease the prevalence of hyperglycaemia and hypoglycaemia in critically ill and major surgery patients in a reliable and effective way.

Enrollment

47 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria;

  • Patients were diagnosed with type 2 diabetes
  • Patients planned to undergo elective major abdominal surgery

Exclusion Criteria;

  • Patients who had diabetes other than type 2 diabetes
  • Patient who had a preoperative glycated haemoglobin A1C (HbA1C) value of 8.5% or greater
  • Patient planned to undergo surgery related to the pancreas

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

Single Blind

47 participants in 2 patient groups

control group
No Intervention group
Description:
We did not perform any intervention on the patients in the control group. These patients received routine glycaemia control and healthcare provided to diabetic patients undergoing surgical intervention in the department of general surgery.After receiving written informed consent, the first part of the data collection form on the socio-demographic and disease characteristics of the patients were completed face-to-face. The BG levels of the patients and the medications and insulin used for glycaemic control were recorded one night before surgery. The anxiety levels of the patients were evaluated on the morning of surgery using State-Trait Anxiety Inventory . The second part of the data collection form , which included information on glycaemic management, glycaemia levels and the medications and insulin used on the morning of surgery and during surgery, intensive care stay and the clinical period, was filled in by the nurse on the monitoring and anaesthesia forms.
intervention group
Experimental group
Description:
Following the introduction of the glycaemic management protocol to the clinic, data on the patients in the intervention group was collected prospectively between June 2018 and December 2018. management was conducted by nurses in line with the protocol. Data on glycaemic management of the intervention group was similar to the control group.the glycaemic management of patients during the perioperative period was conducted by general surgery nurses according to the protoco
Treatment:
Other: glycaemic management protocol implemented to clinic

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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