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An open-label, sequential, dose escalation study of the Pharmacokinetics, Safety, and Preliminary ...
|NPO (Nothing to Eat or Drink by Mouth) instructions: Patient should NOT eat solid food for at least 6 hours before pain management procedure. Patients are however encouraged to drink CLEAR FLUIDS (including water, pulp–free juice and tea or coffee without milk) up to 2 hours before procedure.Ref: Smith I, Kranke P, Veld B etal. Peri-operative fasting in adults and children: guidelines from the European Society of Anesthesiology. European Journal of Anesthesiology, 2011, Vol 28, No 8, page 556 – 569.
PATIENT SHOULD TAKE ALL CARDIAC AND BLOOD PRESSURE MEDICATION WITH SIP OF WATER ON THE DAY OF PROCEDURE AS USUAL.
INSTRUCTION FOR PATIENTS WITH RECENT HISTORY OF INFECTION:
Patient with history of infection associated with fever such as respiratory infection, soar throat from bacterial infection, urinary tract infection such as cystitis, pyelonephritis or kidney infection, etc, should be rescheduled until after the infection has resolved completely with or without antibiotic use. If they are put on antibiotics, then they need to finish the course of antibiotic prior to getting scheduled for the procedure. If a patient catches infection after the procedure, he or she should inform the physician.
INSTRUCTION FOR DIABETIC PATIENTS:
We will make every effort TO SCHEDULE DIABETIC PATIENT EARLY IN THE MORNING.
Our goal is to maintain adequate blood glucose level and avoid hypoglycemia during pre-procedure, intra-procedure and post procedure period until the normal diet is resumed. We would like to achieve this by minimum interruption of the existing patient’s antidiabetic treatment. We will monitor blood glucose before the procedure, and if necessary during and after the procedure.
Ideal blood glucose level should be fasting 90-130 mg/dL and postprandial or after food less than 180 mg/dL. HbA1c < 7% (range 4% – 7%) . A physician would make the final determination. If the HbA1c is > 8 % and the fasting blood glucose is more than 200 mg/ dl than the procedures involving implantable devices such as spinal cord stimulator, intrathecal drug delivery, percutaneous diskectomy, discogram, minimally invasive lumbar decompression procedure, caudal epidural neuroplasty, transforaminal injections, cervical epidural injections etc. would be rescheduled.
The staff at the center would enquire and make sure that the patient is able to check blood glucose level at home.
Blood glucose would be checked on patient’s arrival before the procedure and if necessary after the procedure. It would not be necessary to monitor blood glucose during the procedure for procedures < 2 hours.
Patients with the history of chronically elevated blood sugar level does not require intervention to reduce blood glucose level to a normal level since these patients have altered or abnormal counterregulatory response. On normalization rapidly they would suffer symptoms of hypoglycemia.
Pre-procedure oral antidiabetic and non-insulin injectable therapy:
Oral antidiabetics and non-insulin injectable should not be taken on the day of procedure until the normal diet is resumed.
Long-acting insulin should not be discontinued on the day before procedure unless patient gave history of hypoglycemia at night, in the morning or with missed meals and in patient on diet restriction preoperatively e.g., for bowel preparation.
Combination treatment with using insulin with oral antidiabetic may experience hypoglycemia if a meal is omitted as for example for bowel prep.
LIST OF ANTIDIABETIC MEDICINE:
Sulphonylureas: (Stimulates insulin secretion and decreases insulin resistance). ½ life 2 – 10 hours.
Meglitinides (Stimulates pancreatic insulin secretion. ½ life 1 hour
Thiozolidindiones (Regulate carbohydrate and lipid metabolism, reduce insulin resistance and hepatic glucose production). ½ life: 3- 8 hours.
Alpha-glucosidase inhibitors: Reduces the intestinal absorption of ingested glucose. ½ life 2 – 4 hours .
Dipeptidyl peptidase – 4 (DPP-4): Reduces breakdown of gastrointestinal hormone-incretins (glucagon like peptide type -1, enhance insulin secretion, decrease glucagon). ½ life 8 – 14 hours.
Non insulin Injectables:
Exenatide (Byetta): Synthetic form of Exendin 4, which has actions similar to glucagon-like peptide type 1 (GLP-1). ½ life : 6 – 10 hours. Supresses glucagon and hepatic glucose production. Supresses appetite and delays gastric emptying.
Pramlintide (Symlin): Synthetic form of amylin, a naturally occurring peptide that is cosecrected with insulin by beta cells. Suppresses PP glucagon production. Enhances effect of insulin. Supresses appetite and delays gastric emptying. ½ life 2 – 4 hours.
Metformin may be discontinued 24 hours prior to the treatment provided the patient has history of renal failure.