Efficacy of Intravenous Glyco-P® in Patients Undergoing Procedure That Require Anesthesia Service

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prasert Sawasdiwipachai, Mahidol University
ClinicalTrials.gov Identifier:
NCT02102542
First received: March 30, 2014
Last updated: April 2, 2014
Last verified: March 2014
  Purpose

This observational study was designed to prove clinical efficacy of the well known "glycopyrrolate" which is considered an orphan drug in Thailand. Since the medication has never been officially used in Thai people and this particular brand "Glyco-P" which was made in India has never been officially proven of its efficacy in Thai people. The study was aimed to prove if this Glyco-P can modestly increase patient's heart rate, decrease secretion and safely used in combination with neostigmine for reversal of non-depo muscle relaxant drugs.


Condition
Hypersalivation
Prevention of Drooling
Bradycardia
Reversal of Muscle Relaxants

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Efficacy of Intravenous Glyco-P® in Patients Undergoing Procedure That Require Anesthesia Service

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Efficacy of Glyco-P as an antisialagogue [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Examine efficacy of Glyco-P for reduction of secretion and also for prevention of secretion. The secretions score ranges from 0-5 was evaluated by a person who was blinded to treatment before and after treatment.


Estimated Enrollment: 65
Study Start Date: July 2012
Study Completion Date: April 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Antisialagouge
A group of patients enrolled to prove efficacy of Glyco-P for reduction of secretions.
Bradycardia
A group of patients enrolled to prove efficacy of Glyco-P for modest increase of heart rate.
For reversal of neuromuscular blocking agents
Group of patients enrolled to prove efficacy of Glyco-P when used in combination with neostigmine to reserve neuromuscular blocking agents.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants:- 100 adult male or female patients, over 18 year old who consent to the study.

Exclusion Criteria : Children < 18 yo, pregnant or parturient of breast feeding patients, patients who refused or unable to give consent, patients who has co-existing problems with dry secretion i.e. Sjögren's syndrome, glaucoma, myasthenia gravis, patient whom baseline heart rate is > 100 bpm

Criteria

Inclusion Criteria:

  • adult over 18 years of age, undergoing procedure that require anesthesia service.
  • meet criteria for prevention of drooling, hypersalivation or bradycardia or require reversal of muscle relaxants.

Exclusion Criteria:

  • children < 18 years old,
  • pregnant or parturient of breast feeding patients,
  • patients who refused or unable to give consent,
  • patients who has co-existing problems with dry secretion (i.e. Sjögren's syndrome, glaucoma, myasthenia gravis),
  • patient whom baseline heart rate is > 100 bpm
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02102542

Locations
Thailand
Anesthesiology Department Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
  More Information

Publications:
Responsible Party: Prasert Sawasdiwipachai, Attending physician, Mahidol University
ClinicalTrials.gov Identifier: NCT02102542     History of Changes
Other Study ID Numbers: 185/2555(EC3)
Study First Received: March 30, 2014
Last Updated: April 2, 2014
Health Authority: Thailand: Food and Drug Administration

Keywords provided by Mahidol University:
glycopyrrolate
efficacy
antisialagogue

Additional relevant MeSH terms:
Muscle Hypotonia
Sialorrhea
Bradycardia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anesthetics
Neuromuscular Blocking Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Neuromuscular Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 25, 2014