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Effect of Glycopyrrolate on Vasopressors Requirement for Non-elective Caesarean Section Under Spinal Anaesthesia

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ClinicalTrials.gov Identifier: NCT04401345
Recruitment Status : Recruiting
First Posted : May 26, 2020
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Rajesh Deshar, B.P. Koirala Institute of Health Sciences

Brief Summary:
This is prospective randomised double blind study conducted in parturients planned for non-elective caesarean section under spinal anaesthesia. Glycopyrrolate group will receive 0.2 mg of Glycopyrrolate before start of phenylephrine infusion. Control group will receive 0.2 ml of Normal Saline before start of phenylephrine infusion. Total amount of vasopressors required i.e. ephedrine or phenylephrine will recorded in the form of phenylephrine equivalent during intraoperative period.

Condition or disease Intervention/treatment Phase
Glycopyrrolate Post-spinal Hypotension Effect of Drug Hemodynamic Instability Drug: Glycopyrrolate 0.2 MG/ML Drug: Normal saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 258 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Experimental Group (GP): In the experimental group patients will receive 0.2 mg (1 ml) glycopyrrolate before phenylephrine infusion is initiated.

Placebo Group (NS): In the placebo group patients will receive 1 ml normal saline (0.9%) before phenylephrine infusion is initiated.

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Glycopyrrolate and normal saline will be administered as 1 ml clear fluid, and therefore, both patient and investigator will be blinded to the randomization and intervention.
Primary Purpose: Prevention
Official Title: Effect of Glycopyrrolate on Vasopressors Requirement for Non-elective Caesarean Section Under Spinal Anaesthesia
Actual Study Start Date : June 1, 2020
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : May 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Experimental: Experimental Group (GP)
Patients will receive 0.2 mg (1 ml) glycopyrrolate before phenylephrine infusion is initiated at 25mcg/min.
Drug: Glycopyrrolate 0.2 MG/ML
In this group, the patients will receive glycopyrrolate 0.2 mg in 1 ml
Other Name: Glycopyrronium bromide

Placebo Comparator: Placebo Group(NS)
patients will receive 1 ml normal saline (0.9%) before phenylephrine infusion is initiated at 25 mcg/min
Drug: Normal saline
In this group, the patients will receive 1 ml of 0.9% normal saline
Other Name: 0.9% NS




Primary Outcome Measures :
  1. Total vasopressors requirement intraoperatively [ Time Frame: immediately after spinal anaesthesia till the end of the surgery ]
    Total vasopressors required to prevent hypotension during the period of surgery


Secondary Outcome Measures :
  1. The incidence of hypotension [ Time Frame: after spinal anaesthesia till the end of the surgery ]
    Hypotension is defined as systolic blood pressure < 80% of baseline reading or systolic blood pressure < 100 mmHg

  2. The incidence of reactive hypertension [ Time Frame: after spinal anaesthesia till the end of the surgery ]
    defined as systolic blood pressure > 120% of baseline reading

  3. The incidence of maternal bradycardia [ Time Frame: after spinal anaesthesia till the end of the surgery ]
    heart rate < 55/min

  4. The incidence of maternal tachycardia [ Time Frame: after spinal anaesthesia till the end of the surgery ]
    Heart rate > 100/min

  5. The incidence of nausea [ Time Frame: after spinal anaesthesia till the end of the surgery ]
    Patients will be asked to report the occurrence of intraoperative nausea and rate its severity using an 11-point verbal rating scale (0=no nausea, 10=worst possible nausea).

  6. The incidence of vomiting [ Time Frame: after spinal anaesthesia till the end of the surgery ]
    incidence of vomiting

  7. The incidence of shivering [ Time Frame: after spinal anaesthesia till the end of the surgery ]
    Shivering will be graded as: 0 no shivering, 1 one or more of the following: piloerection, peripheral vasoconstriction, peripheral cyanosis without other cause, but without visible muscular activity; 2 visible muscular activity confined to one muscle group; 3 visible muscular activity in more than one muscle group; and 4 gross muscular activity involving the whole body

  8. The incidence of dry mouth, intraoperative pruritus and dizziness [ Time Frame: after spinal anaesthesia till the end of the surgery ]
    incidence of dry mouth, intraoperative pruritus and dizziness

  9. Maternal heart rate and [ Time Frame: after spinal anaesthesia till the end of the surgery ]
    to record the heart rate of the patient during surgery

  10. Maternal systolic blood pressure [ Time Frame: after spinal anaesthesia till the end of the surgery ]
    to record systolic blood pressure of the patient during surgery


Other Outcome Measures:
  1. The APGAR outcome of baby [ Time Frame: at 1 and 5 min after delivery ]
    APGAR score comprises of 5 criteria : a) Appearance b) Pulse Rate c) Reflex d)Muscle tone e) Respiratory Effort with each criteria of score 0,1 or 2; making total score of 10. Score 7-10 is reassuring, 4-6 moderately normal, 0-3 is low and cause for immediate resuscitative efforts

  2. Need for neonatal resuscitation [ Time Frame: immediately after delivery ]
    resuscitation needed for baby

  3. Admission to neonatal ICU (NICU) [ Time Frame: after delivery ]
    the need for ICU admission

  4. Neonatal death [ Time Frame: within 30 days of delivery ]
    if there is neonatal death or not



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18-40 years
  • All parturients at term (gestational weeks ≥ 37)
  • ASA (American society of Anaesthesiologist) PS (Physical status) grade II

Exclusion Criteria:

  • Age >40 year
  • ASA PS Grade >2
  • Maternal bradycardia (baseline HR< 60/min) or tachycardia (baseline HR> 100/min)
  • Pregnancy induced hypertension
  • Gestational hypertension
  • Known fetal abnormalities
  • Intrauterine growth retardation (IUGR)
  • Intrauterine fetal death (IUFD)
  • Contraindications to spinal anaesthesia
  • Contraindications to glycopyrrolate
  • Multiple pregnancy
  • BMI: > 30 kg/m2
  • Height: <150cm

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): NCT04401345


Contacts
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Contact: Rajesh Deshar, MD/MS 9849808093 raz.deshar@gmail.com
Contact: Asish Subedi, MD/MS 9842040604 asishsubedi19@gmail.com

Locations
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Nepal
B.P.Koirala Institute of Health Sciences Recruiting
Dharān Bāzār, Province 1, Nepal, 56700
Contact: Bishnu Pokhrel, MS    9841829652    drbish20@gmail.com   
Sub-Investigator: Asish Subedi, MD/MS         
Sub-Investigator: Birendra Prasad Sah, MD/MS         
Sub-Investigator: Krishna Pokharel, MD/MS         
Sub-Investigator: Jagat Narayan Prasad, MD/MS         
Principal Investigator: Rajesh Deshar, MD/MS         
Sponsors and Collaborators
Rajesh Deshar
Publications of Results:
Ali S, Athar M, Ahmed SM. Basics of CPB. Indian J Anaesth. 2019;49:257-62.
Cardoso MM, Yamaguchi ET, Amaro AR, Mezzetti R, Torres MA. Fetal and maternal effects of bolus of phenylephrine or metaraminol during spinal anesthesia for cesarean delivery. Anesthesiology. 2005;102:A31--A31.
Quiney NF, Murphy PG. The effect of pretreatment with glycopyrrolate on emetic and hypotensive problems during caesarean section conducted under spinal anaesthesia. Int J Obstet Anesth. 2000;9:156-9.
Bruntion L (ed), Chabner B (ed), Knollman B (ed). Goodman & Gilman's The Pharmacological Basis of Therapeutics. 12th ed. New York: The McGraw Hill Companies; 2011.

Other Publications:
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Responsible Party: Rajesh Deshar, Principal Investigator, B.P. Koirala Institute of Health Sciences
ClinicalTrials.gov Identifier: NCT04401345    
Other Study ID Numbers: IRC/1603/019
First Posted: May 26, 2020    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rajesh Deshar, B.P. Koirala Institute of Health Sciences:
caesarean section
hypotension
spinal anaesthesia
glycopyrrolate
post-spinal anaesthesia
vasopressors
non-elective caesarean section
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Glycopyrrolate
Bromides
Anticonvulsants
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs