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

Phase 4

• Conditions: Lower Extremity Fracture
• Interventions: Drug: Normal Saline Flush, 0.9% Injectable Solution; Drug: Atropine; Drug: Glycopyrrolate

• Registration Number: NCT03580889
• Lead Sponsor: B.P. Koirala Institute of Health Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-15
• Study First Submitted: 2018-06-17
• Study First Submitted QC: 2018-07-06
• Study First Posted: 2018-07-10
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-15
• Last Update Posted: 2018-08-16
• Primary Completion: 2018-09
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 138

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Normal Saline	Normal Saline Flush, 0.9% Injectable Solution	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.
Atropine sulphate	Atropine	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
Glycopyrrolate	Glycopyrrolate	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.

Primary Outcome Measures

Name	Time	Method
Blood pressure from base line will be measured and hypotension will be described and treated as in description section	From anesthesia to 2 hrs after completion of surgery	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
Heart rate will be monitored and treated accordingly	Iv atropine or glycopyrrolate to 2 hrs after completion of surgery	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

Secondary Outcome Measures

Name	Time	Method
Incidence of Nausea and vomiting will be described and treated accordingly.	Initiation of spinal anesthesia to 2 hrs after surgery	0- no nausea no vomiting; 1. light nausea and no vomiting; 2. moderate nausea one or two vomiting episodes; 3. severe nausea, 3 or more vomiting episodes

Trial Locations

Locations (1)

Dr. BishnuPokharel; 🇳🇵 Dharān Bāzār, Sunsari, Nepal