Atropine Versus Glycopyrrolate in Preventing Spinal Anesthesia Induced Hypotension in Lower Limb Surgeries

Study Overview
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Brief Summary
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A study to compare between intravenous atropine and glycopyrrolate in preventing spinal anesthesia induced hypotension in patients undergoing major lower limb orthopedic surgeries. Hypotension is the most common complication in spinal anesthesia that can be life threatening. If this can be prevented patients comfort can be increased and satisfaction as well.

Official Title
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Comparison of Atropine Versus Glycopyrrolate in Preventing Spinal Anesthesia Induced Hypotension in Adult Patient Undergoing Major Lower Limb Orthopedic Surgeries

Conditions
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Lower Extremity Fracture

Intervention / Treatment
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* Drug: Atropine
* Drug: Glycopyrrolate
* Drug: Normal Saline Flush, 0.9% Injectable Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA PS I and II, age 16 to 65, undergoing lower limb major orthopedic surgery, willing to participate Exclusion Criteria: Contra indication to spinal anesthesia, patient refusal, ASA PS >III, cardiac diseases, hypertension >160/ 100, arrhythmias, Acute coronary syndrome, patients taking beta-blockers, hepatic and pulmonary diseases

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Atropine sulphate<br>Atropine 5 mcg/kg diluted in normal saline to total volume of 2 ml is given intravenous 1 minute after giving intrathecal Bupivacaine 0.5% (Heavy) and patients vitals such as blood pressure, heart rate, SPO2 are monitored every 1 minute for 5 minutes ,then every 5 minutes for 30 minutes then every 10 minutes till end of surgery. Patient shifted to PACU where above vitals are monitored for 2 hrs then shifted to ward. Mean while any adverse outcomes such as nausea, vomiting, sweating, dry mouth is noted and treated accordingly | Drug: Atropine<br>* Comparison between atropine, glycopyrrolate and Normal Saline<br>|
| Active Comparator: Glycopyrrolate<br>Glycopyrrolate 2.5 mcg / kg diluted in normal saline to total volume of 2 ml is given intravenous 1 minute after giving intrathecal Bupivacaine 0.5% (Heavy) and patients vitals such as blold pressure, heart rate, SPO2 are monitored every 1 minute for 5 minutes ,then every 5 minutes for 30 minutes then every 10 minutes till end of surgery. Patient shifted to PACU where above vitals are monitored for 2 hrs then shifted to ward. Mean while any adverse outcomes such as nausea, vomiting, sweating, dry mouth is noted and treated accordingly. | Drug: Glycopyrrolate<br>* Comparison between glycopyrrolate, atropine and Normal saline<br>|
| Active Comparator: Normal Saline<br>Normal saline 2 ml is given intravenous 1 minute after giving intrathecal Bupivacaine 0.5% (Heavy) and patients vitals such as blold pressure, heart rate, SPO2 are monitored every 1 minute for 5 minutes ,then every 5 minutes for 30 minutes then every 10 minutes till end of surgery. Patient shifted to PACU where above vitals are monitored for 2 hrs then shifted to ward. Mean while any adverse outcomes such as nausea, vomiting, sweating, dry mouth is noted and treated accordingly. | Drug: Normal Saline Flush, 0.9% Injectable Solution<br>* Comparison between Normal saline, atropine and glycopyrrolate<br>* Other names: Normal Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure from base line will be measured and hypotension will be described and treated as in description section | Systolic arterial pressure <90 mm of hg or 20% decrease from base line or decrease in blood pressure 30 mm Hg or more from base line will be considered hypotension. Hypotension along with tachycardia (as described below) will be treated with phenylephrine 100 mcg and hypotension alone will be treated with mephentermine 6 mg bolus | From anesthesia to 2 hrs after completion of surgery | 
| Heart rate will be monitored and treated accordingly | Heart rate > 100 Bpm or more or more than 20% from base line will be described as tachycardia. Heart rate less than 50 bpm or less than 20% from baseline will be described as bradycardia | Iv atropine or glycopyrrolate to 2 hrs after completion of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Nausea and vomiting will be described and treated accordingly. | 0- no nausea no vomiting light nausea and no vomiting moderate nausea one or two vomiting episodes severe nausea, 3 or more vomiting episodes | Initiation of spinal anesthesia to 2 hrs after surgery |