The effect of Dextromethorphan premedication on cough, pain, anxiety, procedure duration and sedation during fiber optic bronchoscopy: a randomized, double-blind, placebo-controlled trial
1. Objective:
Patients are usually conscious during Fiber Optic Bronchoscopy (FOB), so their cooperation could strongly affect the procedure quality.
2. Design:
Patients scheduled for FOB will be randomly assigned by research supervisor (using random number table) to group-A and group-B. Group-A patients will receive 90 mg syrup Dextromethorphan and group-B will receive syrup sucrose (as placebo).
3. Setting and conduct:
Both group of patient will receive drug or placebo in similar container 90 min before diagnostic FOB. In addition to patients, researcher (who gathers the data) and the physician who performs and monitors the patients during FOB will not be aware of drug/placebo group.
4. Participants including major eligibility criteria:
Inclusion
1- Any documented indication for diagnostic FOB;
2- Age>18;
Exclusion:
1. Allergy to opioids;
2. Taking sedative drugs during last 48 hours;
3. Pregnant woman;
4. Breastfeeding;
5. Patients with central nervous system diseases;
6. Associated unstable medical condition;
7. Emergent FOB;
8. Unconsciousness patients;
9. Intubated patients.
5. Intervention:
90 min before FOB, patients will receive 90 mg (30 cc) of syrup Dextromethorphan (IRC-1228087158) of equivalent placebo (sucrose).
6. Main outcome measures (variables):
-Cough intensity (mild, moderate, severe) during FOB assessed by physician
-Anxiety (mild, moderate, severe) during FOB assessed by patient
-Lidocaine requirement (dose) during FOB assessed by physician
-Midazolam requirement (dose) during FOB assessed by physician
-Fentanyl requirement (dose) during FOB assessed by physician
-General perception about procedure (mild, moderate, severe) during and 2 hours after FOB assessed by patient
-Duration of FOB
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015060520024N2
Registration date:2015-07-06, 1394/04/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-06, 1394/04/15
Registrant information
Name
Soheil Peiman
Name of organization / entity
Tehran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 9922
Email address
s-peiman@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2015-06-01, 1394/03/11
Expected recruitment end date
2015-12-01, 1394/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Dextromethorphan premedication on cough, pain, anxiety, procedure duration and sedation during fiber optic bronchoscopy: a randomized, double-blind, placebo-controlled trial
Public title
The effect of Dextromethorphan premedication on cough, pain, anxiety, procedure duration and sedation during fiber optic bronchoscopy.
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
1- Any documented indication for diagnostic Fiber Optic Bronchoscopy;
2- Age>18;
Exclusion criteria:
1. Allergy to opioid drugs;
2. Taking sedative drugs during last 48 hours;
3. Pregnant woman;
4. Breastfeeding;
5. Patients with central nervous system diseases;
6. Patients with unstable medical condition;
7. Emergent Fiber Optic Bronchoscopy;
8. Impaired level of consciousness;
9. Intubated patients.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Sixty-six patients scheduled for FOB in Imamkhomeini hospital complex will be randomly allocated into two groups according to four blocks (AABB) randomization system. Six states of AABB, ABAB, ABBA, BBAA, BABA, and BAAB will be recorded in six different cards, and then these cards will be mixed together. Consequently, the cars will be selected for 18 times and the order of letters will be registered. The A and B label will be sealed to the researcher and the patients.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Tehran University of Medical Sciences
Street address
6th floor,Vice Chancellor for Research, Tehran University of Medical Sciences central building, Keshavarz blvd. Ghods street.
City
Tehran
Postal code
Approval date
2014-12-31, 1393/10/10
Ethics committee reference number
9111160015-131784
Health conditions studied
1
Description of health condition studied
Respiratory disorder, unspecified
ICD-10 code
J98.9
ICD-10 code description
Respiratory disease (chronic) NOS
Primary outcomes
1
Description
Cough intensity
Timepoint
during FOB
Method of measurement
Physicians' self assessment score
2
Description
Anxiety intensity
Timepoint
during FOB
Method of measurement
Patients' self assessment score
3
Description
Lidocaine requirement
Timepoint
during FOB
Method of measurement
Dose of drug recorded by Physician
4
Description
Midazolam requirement
Timepoint
during FOB
Method of measurement
Dose of drug recorded by Physician
5
Description
Fentanyl requirement
Timepoint
during FOB
Method of measurement
Dose of drug recorded by Physician
6
Description
General perception about procedure
Timepoint
during FOB
Method of measurement
Patients' self assessment score
Secondary outcomes
1
Description
General perception about procedure
Timepoint
2 hours after FOB
Method of measurement
patients' self-assessment score
2
Description
Duration of FOB
Timepoint
at the end of FOB
Method of measurement
time in minutes
Intervention groups
1
Description
Ninety minutes before FOB, 90 mg (30 cc) of syrup Dextromethorphan, manufactured by kharazmi pharmaceutical co, code:IRC-1228087158,
Category
Treatment - Drugs
2
Description
Ninety minutes before FOB, 30cc sucrose syrup
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imamkhomeini hospital, Tehran University of Medical Sciences
Full name of responsible person
Dr. Soheil Peiman
Street address
Gharib Street, End of Keshavarz blvd.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr Ali Javad Mousavi
Street address
Vice chancellor for research, 6th Floor, Central organization of Tehran University of Medical Sciences, Ghods street, Keshavaez blv,
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Department of Internal medicine, Tehran University of Medical Sciences
Full name of responsible person
Dr. Soheil Peiman
Position
Assistant professor
Other areas of specialty/work
Street address
Dr Nafissi's Building, Imamkhomeini hospital complex, Keshavarz blvd.
City
Tehran
Postal code
Phone
+98 21 6693 9922
Fax
Email
s-peiman@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Advanced Thoracic Research Center, Tehran University of Medical Sciences
Full name of responsible person
Dr. Besharat Rahimi
Position
Assistant professor
Other areas of specialty/work
Street address
Advanced Thoracic Research Cente, Imamkhomeini medical complex, Keshavarz blvd.
City
Tehran
Postal code
Phone
+98 21 6658 1594
Fax
Email
besharatrahimi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Internal medicine, Tehran University of Medical Sciences
Full name of responsible person
Dr. Soheil Peiman
Position
Assistant professor
Other areas of specialty/work
Street address
Dr. Nafissi building, ImamKhomeini hospital, Keshavarz blvd.
City
Tehran
Postal code
Phone
+98 937 661 7621
Fax
Email
s-peiman@tums.ac.ir; soheil_peiman@yahoo.com;
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)