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

Sponsor
B.P. Koirala Institute of Health Sciences (Other)
Overall Status
Unknown status
CT.gov ID
NCT03580889
Collaborator
(none)
138
Enrollment
1
Location
3
Arms
11.5
Anticipated Duration (Months)
12
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
138 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Comparison of Atropine Versus Glycopyrrolate in Preventing Spinal Anesthesia Induced Hypotension in Adult Patient Undergoing Major Lower Limb Orthopedic Surgeries
Actual Study Start Date :
Sep 15, 2017
Anticipated Primary Completion Date :
Sep 1, 2018
Anticipated Study Completion Date :
Sep 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Atropine sulphate

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
Comparison between atropine, glycopyrrolate and Normal Saline
Active Comparator: 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.

Drug: Glycopyrrolate
Comparison between glycopyrrolate, atropine and Normal saline
Active Comparator: Normal Saline

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
Comparison between Normal saline, atropine and glycopyrrolate
Other Names:
  • Normal Saline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    1. 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 light nausea and no vomiting moderate nausea one or two vomiting episodes severe nausea, 3 or more vomiting episodes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dr. BishnuPokharel Dharān Bāzār Sunsari Nepal 977

    Sponsors and Collaborators

    • B.P. Koirala Institute of Health Sciences

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Raju Thapamagar, Principal investigator, B.P. Koirala Institute of Health Sciences
    ClinicalTrials.gov Identifier:
    NCT03580889
    Other Study ID Numbers:
    • IRC/1087/017
    First Posted:
    Jul 10, 2018
    Last Update Posted:
    Aug 16, 2018
    Last Verified:
    Aug 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Hypotension
    Atropine
    Glycopyrrolate

    Study Results

    No Results Posted as of Aug 16, 2018