Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 8 of 186 for:    GLYCOPYRROLATE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 17, 2018
First Posted Date  ICMJE July 10, 2018
Last Update Posted Date August 16, 2018
Actual Study Start Date  ICMJE September 15, 2017
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2018)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03580889 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2018)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Atropine Versus Glycopyrrolate in Preventing Spinal Anesthesia Induced Hypotension in Lower Limb Surgeries
Official Title  ICMJE Comparison of Atropine Versus Glycopyrrolate in Preventing Spinal Anesthesia Induced Hypotension in Adult Patient Undergoing Major Lower Limb Orthopedic Surgeries
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Lower Extremity Fracture
Intervention  ICMJE
  • Drug: Atropine
    Comparison between atropine, glycopyrrolate and Normal Saline
  • Drug: Glycopyrrolate
    Comparison between glycopyrrolate, atropine and Normal saline
  • Drug: Normal Saline Flush, 0.9% Injectable Solution
    Comparison between Normal saline, atropine and glycopyrrolate
    Other Name: Normal Saline
Study Arms  ICMJE
  • 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
    Intervention: Drug: Atropine
  • 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.
    Intervention: Drug: Glycopyrrolate
  • 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.
    Intervention: Drug: Normal Saline Flush, 0.9% Injectable Solution
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 6, 2018)
138
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2018
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Bishnu Pokharel, Dr. 025525555 Bpkihs@bpkihs.edu
Listed Location Countries  ICMJE Nepal
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03580889
Other Study ID Numbers  ICMJE IRC/1087/017
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: I do not want to share IPD with other investigators
Responsible Party Raju Thapamagar, B.P. Koirala Institute of Health Sciences
Study Sponsor  ICMJE B.P. Koirala Institute of Health Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account B.P. Koirala Institute of Health Sciences
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP