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Trial record 8 of 8 for:    UNISOM OR Unisom OR DOXYLAMINE OR Doxy-Sleep-Aid OR DOXYLAMINE SUCCINATE OR DECAPRYN OR Decapryn OR DOXY-SLEEP-AID

Alternative Sedation During Bronchoscopy (DEX)

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ClinicalTrials.gov Identifier: NCT01158820
Recruitment Status : Completed
First Posted : July 8, 2010
Results First Posted : October 31, 2018
Last Update Posted : February 26, 2019
Sponsor:
Collaborator:
Hospira, now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Sedation
Interventions Drug: Dexmedetomidine load
Drug: Ketamine load
Drug: Midazolam load
Drug: Fentanyl load
Drug: Dexmedetomidine maintenance
Drug: Ketamine maintenance
Drug: Midazolam demand
Drug: Fentanyl demand
Drug: Benadryl demand
Enrollment 50
Recruitment Details Patients were recruited from the practices of the pulmonologist sub investigators by the principal investigator
Pre-assignment Details  
Arm/Group Title Placebo Dexmedetomidine and Ketamine
Hide Arm/Group Description
  1. Nebulized lidocaine 2% (maximum dose 200 mg) will be administered for 20 minutes.
  2. Following nebulization, syringe A (placebo) will be given at a rate of 1 µg/kg (based on a concentration of 4 µg/ml) for 10 minutes. Supplemental topical anesthesia will be administered by the pulmonologist during this time.
  3. After step 2, syringe B (midazolam 2 mg and fentanyl 50 µg) will be administered by the anesthesiologist. The infusion rate of syringe A (placebo) will be decreased to 0.7 µg/kg/hr. Syringe C (placebo) will be infused at 4 µg/kg/min (based on 10 mg/ml concentration)
  4. Boluses of 0.5 mg midazolam and 12.5 µg fentanyl will be administered by the pulmonologist from syringe D as needed for patient comfort. Syringe E (benadryl 25 mg) will be administered in entirety by the anesthesiologist after the 6th and 16th bolus of midazolam/fentanyl.

placebo + Standard of Care of midazolam and fentanyl: Control Saline 50 ml Midazolam 2 mg + Fentanyl 50 µg Saline 20 ml Midazolam 1

  1. Nebulized lidocaine 2% (maximum dose 200 mg) will be administered for 20 minutes.
  2. Following nebulization, syringe A (dexmedetomidine) will be given at a rate of 1 µg/kg (based on a concentration of 4 µg/ml) for 10 minutes. Supplemental topical anesthesia will be administered by the pulmonologist during this time.
  3. After step 2, syringe B (ketamine 30 mg) will be administered by the anesthesiologist. The infusion rate of syringe A (dexmedetomidine) will be decreased to 0.7 µg/kg/hr. Syringe C (ketamine) will be infused at 4 µg/kg/min (based on 10 mg/ml concentration)
  4. Boluses of 0.5 mg midazolam and 12.5 µg fentanyl will be administered by the pulmonologist from syringe D as needed for patient comfort. Syringe E (benadryl 25 mg) will be administered in entirety by the anesthesiologist after the 6th and 16th bolus of midazolam/fentanyl.

dexmedetomidine and ketamine Study Medication: Experimental Dexmedetomidine 200 µg in 50 ml Ketamine 30 mg Ketamine 200 mg in 20 ml M

Period Title: Overall Study
Started 25 25
Completed 25 25
Not Completed 0 0
Arm/Group Title Placebo Dexmedetomidine and Ketamine Total
Hide Arm/Group Description Placebo + Standard of Care of midazolam and fentanyl dexmedetomidine and ketamine + Standard of Care of midazolam and fentanyl Total of all reporting groups
Overall Number of Baseline Participants 25 25 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
 100.0%
25
 100.0%
50
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 50 participants
59.4  (13.2) 61.2  (14.9) 59.88  (15.86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 50 participants
Female
13
  52.0%
6
  24.0%
19
  38.0%
Male
12
  48.0%
19
  76.0%
31
  62.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 25 participants 50 participants
25 25 50
1.Primary Outcome
Title Decreased Minute Ventilation
Hide Description An initial baseline minute ventilation estimate was obtained via calibrated respiratory impedance plethysmography bands. Subsequent minute ventilation was normalized to this value. Values exceeding 100% were excluded from analysis, as these typically reflected a period of hyperpnea subsequent to relief of airway obstruction by chin lift or jaw thrust.
Time Frame During the bronchoscopy procedure only, 58.5 minutes average
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Dexmedetomidine and Ketamine
Hide Arm/Group Description:
Placebo + Standard of Care of midazolam and fentanyl
dexmedetomidine and ketamine + Standard of Care (Midazolam + fentanyl)
Overall Number of Participants Analyzed 25 25
Median (Inter-Quartile Range)
Unit of Measure: percentage of baseline
0.736
(0.592 to 0.848)
0.764
(0.592 to 0.891)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dexmedetomidine and Ketamine
Comments [Not Specified]
Type of Statistical Test Other
Comments No data available for power analysis
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.028
Estimation Comments [Not Specified]
2.Primary Outcome
Title Total Fentanyl
Hide Description Total fentanyl dose delivered during the procedure
Time Frame During the bronchoscopy procedure only, 58.5 minutes average
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Dexmedetomidine and Ketamine
Hide Arm/Group Description:
Placebo + Standard of Care of midazolam and fentanyl
dexmedetomidine and ketamine + Standard of Care (midazolam + fentanyl)
Overall Number of Participants Analyzed 25 25
Median (Inter-Quartile Range)
Unit of Measure: µg
112.5
(87.5 to 188.4)
68.75
(21.9 to 103.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dexmedetomidine and Ketamine
Comments See reference power analysis
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 43.75
Estimation Comments units are µg
3.Primary Outcome
Title Total Midazolam
Hide Description Total midazolam delivered during procedure
Time Frame Duration of procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Dexmedetomidine and Ketamine
Hide Arm/Group Description:
Placebo + Standard of Care of midazolam and fentanyl
dexmedetomidine and ketamine + Standard of Care (Midazolam + fentanyl)
Overall Number of Participants Analyzed 25 25
Median (Inter-Quartile Range)
Unit of Measure: mg
4.5
(3.5 to 7.5)
2.75
(0.9 to 4.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Dexmedetomidine and Ketamine
Comments See reference for power analysis
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 1.75
Estimation Comments units are mg
4.Secondary Outcome
Title Desaturation (Cumulative)
Hide Description Cumulative time below saturation of 90% - the total number of seconds that the pulse oximeter reported a saturation below 90%
Time Frame During the bronchoscopy procedure only, 58.5 minutes average
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Dexmedetomidine and Ketamine
Hide Arm/Group Description:
Placebo + Standard of Care of midazolam and fentanyl
dexmedetomidine and ketamine + Standard of Care (Midazolam + fentanyl)
Overall Number of Participants Analyzed 25 25
Median (Inter-Quartile Range)
Unit of Measure: seconds
39
(8.5 to 117.5)
40
(3.8 to 170.5)
5.Secondary Outcome
Title Desaturation (Longest)
Hide Description Longest time below saturation of 90% (the number of seconds elapsed between the start of a period in which the pulse oximeter saturation fell below 90% and the return above 90%)
Time Frame During the bronchoscopy procedure only, 58.5 minutes average
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Dexmedetomidine and Ketamine
Hide Arm/Group Description:
Placebo + Standard of Care of midazolam and fentanyl
dexmedetomidine and ketamine + Standard of Care (Midazolam + fentanyl)
Overall Number of Participants Analyzed 25 25
Median (Inter-Quartile Range)
Unit of Measure: seconds
21
(5 to 43.5)
18
(3 to 53.3)
6.Secondary Outcome
Title Conversion to General Anesthesia
Hide Description Patients in which the procedure could not be completed without conversion to general anesthesia
Time Frame During the bronchoscopy procedure only, 58.5 minutes average
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Dexmedetomidine and Ketamine
Hide Arm/Group Description:
Placebo + Standard of Care of midazolam and fentanyl
dexmedetomidine and ketamine + Standard of Care (Midazolam + fentanyl)
Overall Number of Participants Analyzed 25 25
Measure Type: Count of Participants
Unit of Measure: Participants
6
  24.0%
1
   4.0%
7.Secondary Outcome
Title Patient Satisfaction
Hide Description Satisfaction rated by 10 point Likert scale (0 = Totally dissatisfied, 10 = Totally satisfied)
Time Frame After the bronchoscopy procedure only
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Dexmedetomidine and Ketamine
Hide Arm/Group Description:
Placebo + Standard of Care of midazolam and fentanyl
dexmedetomidine and ketamine + Standard of Care (Midazolam + fentanyl)
Overall Number of Participants Analyzed 25 25
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
9
(7 to 10)
10
(5 to 10)
8.Secondary Outcome
Title Endoscopist Satisfaction
Hide Description Satisfaction rated by 10 point Likert scale (0 = Totally dissatisfied, 10 = Totally satisfied)
Time Frame After the bronchoscopy procedure only
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Dexmedetomidine and Ketamine
Hide Arm/Group Description:
Placebo + Standard of Care of midazolam and fentanyl
dexmedetomidine and ketamine + Standard of Care (Midazolam + fentanyl)
Overall Number of Participants Analyzed 25 25
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
7
(5.5 to 8.5)
8
(6 to 9.5)
Time Frame The AE data was collected over a 2 year period from the enrollment date for each participant .
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Dexmedetomidine and Ketamine
Hide Arm/Group Description Placebo + Standard of Care (midazolam and fentanyl) dexmedetomidine and ketamine + Standard of Care (midazolam + fentanyl)
All-Cause Mortality
Placebo Dexmedetomidine and Ketamine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Dexmedetomidine and Ketamine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Dexmedetomidine and Ketamine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/25 (0.00%) 

The presence of an anesthesiologist may have affected the aggressiveness of the pulmonologists in administering sedation.

Alterations in the study drug were not permitted; an open label study might find larger differences in respiratory measures

Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Jeff E Mandel MD MS
Organization: Department of Anesthesiology & Critical Care
Phone: 2156150553
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01158820     History of Changes
Other Study ID Numbers: 810981
First Submitted: June 25, 2010
First Posted: July 8, 2010
Results First Submitted: August 29, 2018
Results First Posted: October 31, 2018
Last Update Posted: February 26, 2019