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Trial record 8 of 107 for:    ( Map: Nepal )

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

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ClinicalTrials.gov Identifier: NCT03580889
Recruitment Status : Recruiting
First Posted : July 10, 2018
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Raju Thapamagar, 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.

Condition or disease Intervention/treatment Phase
Lower Extremity Fracture Drug: Atropine Drug: Glycopyrrolate Drug: Normal Saline Flush, 0.9% Injectable Solution Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 15, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


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 Name: Normal Saline




Primary Outcome Measures :
  1. Blood pressure from base line will be measured and hypotension will be described and treated as in description section [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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



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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03580889


Contacts
Contact: Bishnu Pokharel, Dr. 025525555 Bpkihs@bpkihs.edu

Locations
Nepal
Dr. BishnuPokharel Recruiting
Dharān Bāzār, Sunsari, Nepal, 977
Contact: Bishnu Pokharel, Dr.    025525555    Bpkihs@bpkihs.edu   
Principal Investigator: Raju Thapamagar, Dr         
Sponsors and Collaborators
B.P. Koirala Institute of Health Sciences

Publications of Results:
Other Publications:
Paul g. Barash clinical anesthesia 7th edition
Sigdel S. Prophylactic use of iv atropine for prevention of spinal anesthesia induced hypotension and bradycardia in elderly. A randomized controlled trial. J anesthesiol clin res.2015;4(1):5

Responsible Party: Raju Thapamagar, Principal investigator, B.P. Koirala Institute of Health Sciences
ClinicalTrials.gov Identifier: NCT03580889     History of Changes
Other Study ID Numbers: IRC/1087/017
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: I do not want to share IPD with other investigators

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
Vascular Diseases
Cardiovascular Diseases
Atropine
Glycopyrrolate
Adjuvants, Anesthesia
Anti-Arrhythmia Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Parasympatholytics
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action