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Trial record 6 of 312 for:    Clonidine

Effect of Intrathecal Clonidine in Hypertensive Subjects With Poorly Controlled Blood Pressure

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ClinicalTrials.gov Identifier: NCT01297335
Recruitment Status : Completed
First Posted : February 16, 2011
Results First Posted : January 1, 2016
Last Update Posted : October 19, 2016
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
The Center for Clinical Research, Winston-Salem, NC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypertension
Intervention Drug: clonidine
Enrollment 10

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intrathecal Clonidine
Hide Arm/Group Description

Subject will receive one time Clonidine injection via lower lumber interspace. Clonidine (Duraclon), 100 μg/ml, 1.5 ml will be diluted to 2 ml with preservative free saline, and total of 150 μg will be delivered. Supine and sitting blood pressures and heart rate will be measured at 10 minute intervals until 60 minutes after clonidine administration, then at 15 minutes for next 3 hours.

clonidine: Intrathecal Clonidine

Period Title: Overall Study
Started 10
Completed 10
Not Completed 0
Arm/Group Title Intrathecal Clonidine
Hide Arm/Group Description All subjects met all inclusion and exclusionary criteria, and we report study subjects' demographic information in following sections.
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
57  (5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
8
  80.0%
Male
2
  20.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants
African American, Non-hispanic 7
White, Non-hispanic 3
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
Duration of Hypertension Diagnosis  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants
17
(6 to 25)
Number of active antihypertensive medications  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants
4 active antihypertensive medications 8
3 active antihypertensive medications 2
1.Primary Outcome
Title Change in Blood Pressure After Intrathecal Injection of Clonidine.
Hide Description

Subjects baseline blood pressure (systolic blood pressure (SBP), and diastolic blood pressure (DBP)), and blood pressures after clonidine injection was compared against baseline to assess efficacy of clonidine in refractory hypertensive subjects. Subject's blood pressure was monitored continuously after intrathecal injection of clonidine until subjects blood pressure nadir and return to pre clonidine injection level. The mean value reported below are the average changes in blood pressure from baseline (pre clonidine injection) in both SBP and DBP during post clonidine injection blood pressure monitoring for 4 hours.

Blood pressure measurements were collected every 10 minutes for first hour after injection, and every 15 minutes after the first hour, up to 4 hours were averaged to report the change from baseline.

Time Frame Baseline, Every 10 Minutes for first hour after clonidine injection, and every 15 minutes after first hour, until 4 hours after clonidine injection
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects met inclusion and exclusionary criteria, and was given an intrathecal injection of clonidine. They were followed for changes in blood pressure for 4 hours.
Arm/Group Title Intrathecal Clonidine
Hide Arm/Group Description:
Subject received one time Clonidine injection via lower lumber interspace. Clonidine (Duraclon), 100 μg/ml, 1.5 ml will be diluted to 2 ml with preservative free saline, and total of 150 μg were delivered. Supine and sitting blood pressures and heart rate were measured at 10 minute intervals until 60 minutes after clonidine administration, then at 15 minutes for next 3 hours.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: mm Hg
Change in mean SBP after clonidine injection 79  (28)
Change in DBP after clonidine injection 37  (17)
2.Secondary Outcome
Title Likert Scale Pain Rating
Hide Description Likert scale is 11 point digital pain rating system that asks subjects to rate their pain from 0 to 10. Rating of 0 means no pain at all, and in increasing order, 10 would mean worst pain imaginable/ unbearable pain.
Time Frame Pre-dose and 1 hour post injection.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects met inclusion and exclusionary criteria, and received intrathecal injection of clonidine. Subjects were asked to rate their baseline pain on Likert scale prior to receiving intrathecal clonidine injection, and 1 hour post intrathecal clonidine injection.
Arm/Group Title Intrathecal Clonidine
Hide Arm/Group Description:

Subject will receive one time Clonidine injection via lower lumber interspace. Clonidine (Duraclon), 100 μg/ml, 1.5 ml will be diluted to 2 ml with preservative free saline, and total of 150 μg will be delivered. Supine and sitting blood pressures and heart rate will be measured at 10 minute intervals until 60 minutes after clonidine administration, then at 15 minutes for next 3 hours.

clonidine: Intrathecal Clonidine

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pre-injection average Likert score 6.5  (1.9)
Post-injection average Likert score 3.6  (2.6)
3.Secondary Outcome
Title Changes in Visual Analogue Scale (VAS) Ratings of Sedation and Sensation of Dry Mouth Reported by the Subjects, Pre and 1 Hour Post Injection
Hide Description Subjects were asked to rate severity of two of the most common side effects of clonidine, sedation and sensation of dry mouth, at pre and post (1 hour after) intrathecal administration of clonidine. The mean changes between pre and post injection VAS ratings of sedation and sensation of dry mouth are reported below. The VAS scale ranges from 1 to 10 cm, with higher values indicating higher level of sedation and higher level of dry mouth.
Time Frame Before clonidine injection (Baseline), and at 1 hour after clonidine injection.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All qualified subjects were given intrathecal clonidine and were asked to rate level of sedation and sensation of dry mouth before clonidine injection (baseline) and 1 hour post injection on VAS scale.
Arm/Group Title Intrathecal Clonidine
Hide Arm/Group Description:
Subjects were asked to rate both level of sedation and dryness of their mouths (two of the most common side effects of clonidine) at before clonidine injection (baseline) and at one hour after clonidine injection (Post injection) on VAS scale. VAS scale is an analogue scale that measures subject response from 0 to 10 cm, where larger value represents greater level of sedation and dryness in the mouth subject experienced.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: cm
Change in level of sedation 3.36  (3.66)
Change in sensation of dry mouth 3.47  (3.93)
Time Frame Adverse events were collected during the duration of the study. Some adverse events, such as pregnancy that occurred during the study would have been followed until the delivery of fetus or termination of pregnancy.
Adverse Event Reporting Description Events such as spinal headaches, or hypotension requiring intravenous fluids or vasopressor intervention
 
Arm/Group Title Intrathecal Clonidine
Hide Arm/Group Description

Subject will receive one time Clonidine injection via lower lumber interspace. Clonidine (Duraclon), 100 μg/ml, 1.5 ml will be diluted to 2 ml with preservative free saline, and total of 150 μg will be delivered. Supine and sitting blood pressures and heart rate will be measured at 10 minute intervals until 60 minutes after clonidine administration, then at 15 minutes for next 3 hours.

clonidine: Intrathecal Clonidine

All-Cause Mortality
Intrathecal Clonidine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intrathecal Clonidine
Affected / at Risk (%)
Total   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intrathecal Clonidine
Affected / at Risk (%)
Total   0/10 (0.00%) 
This study was limited by small sample size, and lack of control group.
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
Name/Title: Medical Director
Organization: The Center for Clinical Research
Phone: 3367656181
Publications:
Responsible Party: The Center for Clinical Research, Winston-Salem, NC
ClinicalTrials.gov Identifier: NCT01297335     History of Changes
Other Study ID Numbers: 1461 Clonidine
1461 ( Other Grant/Funding Number: Medtronic )
First Submitted: February 14, 2011
First Posted: February 16, 2011
Results First Submitted: July 27, 2015
Results First Posted: January 1, 2016
Last Update Posted: October 19, 2016