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

Primary Purpose

Lower Extremity Fracture

Status
Unknown status
Phase
Phase 4
Locations
Nepal
Study Type
Interventional
Intervention
Atropine
Glycopyrrolate
Normal Saline Flush, 0.9% Injectable Solution
Sponsored by
B.P. Koirala Institute of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lower Extremity Fracture

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dr. BishnuPokharelRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Atropine sulphate

Glycopyrrolate

Normal Saline

Arm Description

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 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.

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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

Full Information

First Posted
June 17, 2018
Last Updated
August 15, 2018
Sponsor
B.P. Koirala Institute of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03580889
Brief Title
Atropine Versus Glycopyrrolate in Preventing Spinal Anesthesia Induced Hypotension in Lower Limb Surgeries
Official Title
Comparison of Atropine Versus Glycopyrrolate in Preventing Spinal Anesthesia Induced Hypotension in Adult Patient Undergoing Major Lower Limb Orthopedic Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2017 (Actual)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
B.P. Koirala Institute of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Extremity Fracture

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Atropine sulphate
Arm Type
Active Comparator
Arm Description
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
Arm Title
Glycopyrrolate
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Normal Saline
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Atropine
Intervention Description
Comparison between atropine, glycopyrrolate and Normal Saline
Intervention Type
Drug
Intervention Name(s)
Glycopyrrolate
Intervention Description
Comparison between glycopyrrolate, atropine and Normal saline
Intervention Type
Drug
Intervention Name(s)
Normal Saline Flush, 0.9% Injectable Solution
Other Intervention Name(s)
Normal Saline
Intervention Description
Comparison between Normal saline, atropine and glycopyrrolate
Primary Outcome Measure Information:
Title
Blood pressure from base line will be measured and hypotension will be described and treated as in description section
Description
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
Time Frame
From anesthesia to 2 hrs after completion of surgery
Title
Heart rate will be monitored and treated accordingly
Description
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
Time Frame
Iv atropine or glycopyrrolate to 2 hrs after completion of surgery
Secondary Outcome Measure Information:
Title
Incidence of Nausea and vomiting will be described and treated accordingly.
Description
0- no nausea no vomiting light nausea and no vomiting moderate nausea one or two vomiting episodes severe nausea, 3 or more vomiting episodes
Time Frame
Initiation of spinal anesthesia to 2 hrs after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bishnu Pokharel, Dr.
Phone
025525555
Email
Bpkihs@bpkihs.edu
Facility Information:
Facility Name
Dr. BishnuPokharel
City
Dharān Bāzār
State/Province
Sunsari
ZIP/Postal Code
977
Country
Nepal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bishnu Pokharel, Dr.
Phone
025525555
Email
Bpkihs@bpkihs.edu
First Name & Middle Initial & Last Name & Degree
Raju Thapamagar, Dr

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
I do not want to share IPD with other investigators
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result

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

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