Hypotension During Surgery
Conditions
Brief summary
Orthopedic lower limb procedures are carried out under spinal anesthesia which involves administration of drugs in the space surrounding the spinal cord. From there the drug acts on the spinal cord blocking electrical signals moving across nerve fibers thereby providing sufficient pain relief and surgical conditions. However blocking of these fibers result in reduce signal transmission to blood vessels and heart resulting in fall in blood pressure. Various drugs can be used to treat or prevent this hypotension. One such drug is Dexamethasone which is a steroid. This drug can be administered before spinal anesthesia through Intravenous route to prevent fall in blood pressure.
Detailed description
Lower limb orthopedic surgeries are carried out under Sub Arachnoid block which is associated with sympathectomy resulting in vasodilation and hypotension. The hypotension can compromise end organ perfusion and pre-disposes the person to end organ damage such as Myocardial infarction, stroke and renal injury. Therefore treatment and prevention of post spinal hypotension is one of the major goals to improve peri-operative outcomes. One such drug which can be used to prevent post spinal hypotension is Dexamethasone which can be given prophylactically to prevent post spinal hypotension as the drug causes increase in systemic vascular resistance thereby counteracting post spinal vasodilation and hypotension.
Interventions
DRUGDexamethasone
8 mg of Intravenous Dexamethasone in 100 ml Normal saline given 1 hour before anesthesia induction
DRUGPlacebo
100ml of Normal saline administration 1 hour before anesthesia induction
Sponsors
Pakistan Institute of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
After taking informed consent participants will be divided into two equal groups using computer generated random numbers. The participants in group D will receive 8 mg of IV Dexamethasone in 100ml Normal saline 1 hour before induction of spinal anesthesia while participants in group C will receive 100ml of Normal saline 1 hour before induction of spinal anesthesia. 1 hour after administration of IV Dexamethasone or placebo patient will be brought into OR, ASA monitoring will be attached, Sub Arachnoid block will be induced with 15mg of hyperbaric bupivacaine, patient will be made to lie down, level of block will be assessed and surgery will be started. Intraoperatively hemodynamics will be recorded at 5 minutes interval for first 30 minutes. Any fall in blood pressure by more than 20% from baseline will be noted and treated with Phenylephrine IV bolus.
Eligibility
Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients undergoing orthopedic surgery under spinal anaesthesia. * ASA I & II.
Exclusion criteria
* Known case of ischemic heart disease. * Patients having contraindication to spinal anesthesia (e.g.- coagulopathy, thrombocytopenia, allergy to local anesthetic agent). * Patients using corticosteroids or drugs that affect serotonin (e.g., selective serotonin reuptake inhibitor). * Patients with uncorrected hypovolemia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure | baseline, 5 mins, 10 mins, 15 mins, 20 mins, 25 mins,30 mins | This is the highest blood pressure during cardiac cycle occurring at the peak of systole measured by Non invasive automated blood pressure cuff |
| Diastolic Blood Pressure | baseline, 5 mins, 10 mins, 15 mins, 20 mins, 25 mins,30 mins | This is the lowest blood pressure during cardiac cycle measured by Non invasive automated blood pressure cuff |
| Mean Blood Pressure | baseline, 5 mins, 10 mins, 15 mins, 20 mins, 25 mins,30 mins | This is the average blood pressure during cardiac cycle measured by Non invasive automated blood pressure cuff |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Hypotensive episodes | Intraoperative period | This will be the number of times in the intraoperative period the patient experience fall in either systolic, diastolic or mean blood pressure by more than 20% from baseline |
| Rescue Phenylephrine | Intraoperative period | This will be the total amount of phenylephrine administered in intraoperative period to the patient in case of fall in either systolic, diastolic or mean blood pressure by more than 20% from baseline |
| Rescue intravenous fluid | Intraoperative period | This will be the total amount of IV crystalloid fluid administered in intraoperative period to the patient in case of fall in either systolic, diastolic or mean blood pressure by more than 20% from baseline |
Countries
Pakistan
Outcome results
None listed