Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 10 of 186 for:    GLYCOPYRROLATE

Effectiveness of Atropine and Glycopyrrolate to Reduce Hyper Salivation With Ketamine Sedation

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01191398
Recruitment Status : Completed
First Posted : August 30, 2010
Results First Posted : March 20, 2014
Last Update Posted : April 16, 2014
Sponsor:
Information provided by (Responsible Party):
Craig J. Huang, University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition Sialorrhea
Interventions Drug: Atropine (0.01mg/kg)
Drug: Glycopyrrolate (0.01mg/kg)
Drug: Normal saline 0.9%
Enrollment 52
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Atropine Glycopyrrolate
Hide Arm/Group Description

Normal Saline0.9% will act as a placebo.

Placebo: Normal Saline of 0.9% will be given at a volume of 2mL. This medication will be given once by IV 30 minutes before the administration of Ketamine

Atropine (0.01mg/kg): Atropine will be given at 0.01mg/kg with a minimum dosage of 0.1mg and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine. Glycopyrrolate (0.01mg/kg): Glycopyrrolate will be given at 0.01mg/kg with no minimum dosage and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
Period Title: Overall Study
Started 17 17 18
Completed 17 17 18
Not Completed 0 0 0
Arm/Group Title Placebo Atropine Glycopyrrolate Total
Hide Arm/Group Description

Normal Saline0.9% will act as a placebo.

Placebo: Normal Saline of 0.9% will be given at a volume of 2mL. This medication will be given once by IV 30 minutes before the administration of Ketamine

Atropine (0.01mg/kg): Atropine will be given at 0.01mg/kg with a minimum dosage of 0.1mg and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine. Glycopyrrolate (0.01mg/kg): Glycopyrrolate will be given at 0.01mg/kg with no minimum dosage and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine. Total of all reporting groups
Overall Number of Baseline Participants 17 17 18 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 17 participants 18 participants 52 participants
5.34  (4.07) 5.09  (3.76) 4.48  (3.09) 4.85  (3.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 18 participants 52 participants
Female
6
  35.3%
8
  47.1%
11
  61.1%
25
  48.1%
Male
11
  64.7%
9
  52.9%
7
  38.9%
27
  51.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 17 participants 18 participants 52 participants
17 17 18 52
1.Primary Outcome
Title Difference in Salivary Flow Rate (ml/Min) Between Study Groups
Hide Description Oral Secretions will be collected by oral suctioning starting at the time Ketamine is administed until 30 minutes post Ketamine administration. Suctionings will be done by trained personnel every 5 minutes starting with the Ketamine administration. Flow rate will be calculated by dividing the total volume of saliva suctioned by the total time suctioned (30 minutes)
Time Frame 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Atropine Glycopyrrolate
Hide Arm/Group Description:

Normal Saline0.9% will act as a placebo.

Placebo: Normal Saline of 0.9% will be given at a volume of 2mL. This medication will be given once by IV 30 minutes before the administration of Ketamine

Atropine (0.01mg/kg): Atropine will be given at 0.01mg/kg with a minimum dosage of 0.1mg and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
Glycopyrrolate (0.01mg/kg): Glycopyrrolate will be given at 0.01mg/kg with no minimum dosage and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
Overall Number of Participants Analyzed 17 17 18
Mean (Standard Deviation)
Unit of Measure: ml/min
.072  (0.111) .003  (0.0084) NA [1]   (NA)
[1]
No detectable measurable amount was collected, so mean and SD could not be calculated.
2.Secondary Outcome
Title Monitoring of Adverse Events During Study Administration
Hide Description Subjects will be monitored for episodes of apnea, laryngospasm, vomiting, oxygen desaturation(<92%), and changes in heart rate and blood pressure. The time frame will include the time the study medication is administered until at least 30 minutes post Ketamine administration.
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Atropine Glycopyrrolate
Hide Arm/Group Description:

Normal Saline0.9% will act as a placebo.

Placebo: Normal Saline of 0.9% will be given at a volume of 2mL. This medication will be given once by IV 30 minutes before the administration of Ketamine

Atropine (0.01mg/kg): Atropine will be given at 0.01mg/kg with a minimum dosage of 0.1mg and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
Glycopyrrolate (0.01mg/kg): Glycopyrrolate will be given at 0.01mg/kg with no minimum dosage and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
Overall Number of Participants Analyzed 17 17 18
Measure Type: Number
Unit of Measure: adverse events
1 0 0
Time Frame 9 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Atropine Glycopyrrolate
Hide Arm/Group Description

Normal Saline0.9% will act as a placebo.

Placebo: Normal Saline of 0.9% will be given at a volume of 2mL. This medication will be given once by IV 30 minutes before the administration of Ketamine

Atropine (0.01mg/kg): Atropine will be given at 0.01mg/kg with a minimum dosage of 0.1mg and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine. Glycopyrrolate (0.01mg/kg): Glycopyrrolate will be given at 0.01mg/kg with no minimum dosage and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
All-Cause Mortality
Placebo Atropine Glycopyrrolate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Atropine Glycopyrrolate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/17 (0.00%)      0/17 (0.00%)      0/18 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Atropine Glycopyrrolate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/17 (5.88%)      0/17 (0.00%)      0/18 (0.00%)    
Gastrointestinal disorders       
Vomiting  [1]  1/17 (5.88%)  1 0/17 (0.00%)  0 0/18 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Episode of vomiting, post sedation. However, patient able to tolerate oral intake prior to hospital discharge.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Craig J. Huang, MD
Organization: University of Texas Southwestern Dallas Medical Center
Phone: 214-456-6371
EMail: craig.huang@utsouthwestern.edu
Layout table for additonal information
Responsible Party: Craig J. Huang, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01191398     History of Changes
Other Study ID Numbers: 012008-058
First Submitted: August 27, 2010
First Posted: August 30, 2010
Results First Submitted: December 11, 2013
Results First Posted: March 20, 2014
Last Update Posted: April 16, 2014