Efficacy of Intravenous Glyco-P® in Patients Undergoing Procedure That Require Anesthesia Service
This study has been completed.
Information provided by (Responsible Party):
Prasert Sawasdiwipachai, Mahidol University
First received: March 30, 2014
Last updated: April 2, 2014
Last verified: March 2014
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.
Prevention of Drooling
Reversal of Muscle Relaxants
||Time Perspective: Prospective
||Efficacy of Intravenous Glyco-P® in Patients Undergoing Procedure That Require Anesthesia Service
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2013 (Final data collection date for primary outcome measure)
A group of patients enrolled to prove efficacy of Glyco-P for reduction of secretions.
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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
- 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.
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02102542
|Anesthesiology Department Siriraj Hospital
|Bangkoknoi, Bangkok, Thailand, 10700 |
||Prasert Sawasdiwipachai, Attending physician, Mahidol University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 30, 2014
||April 2, 2014
||Thailand: Food and Drug Administration
Keywords provided by Mahidol University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 25, 2014
Nervous System Diseases
Signs and Symptoms
Salivary Gland Diseases
Neuromuscular Blocking Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents
Peripheral Nervous System Agents