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

NCT02102542 | Completed

• 1 other identifier: 185/2555(EC3)
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypersalivation; Prevention of Drooling; Bradycardia; Reversal of Muscle Relaxants

Keywords

glycopyrrolate; efficacy; antisialagogue

Outcome Measures

Primary Outcomes (1)

• Efficacy of Glyco-P as an antisialagogue

  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.

  3 months

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Anesthesiology Department Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

Location

Related Publications (1)

• Salem MG, Richardson JC, Meadows GA, Lamplugh G, Lai KM. Comparison between glycopyrrolate and atropine in a mixture with neostigmine for reversal of neuromuscular blockade. Studies in patients following open heart surgery. Br J Anaesth. 1985 Feb;57(2):184-7. doi: 10.1093/bja/57.2.184.

  PMID: 2857570 BACKGROUND

MeSH Terms

Conditions

Sialorrhea; Bradycardia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: March 30, 2014
• First Posted: April 3, 2014
• Study Start: July 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 3, 2014

Record last verified: 2014-03

Locations

TH (1)