The aim of this prospective, randomized study was to compare the standard regimen of midazolam with infusion of dexmedetomidine for sedation during transesophageal echocardiography. Inclusion criteria was patients scheduled for TEE and ages of 18-60 years. Patients were excluded of study if they have previous TEE and upper digestive system endoscopic examinations; emergency examinations; pregnancy; mechanical ventilation; patients with psychiatric and emotional disorder; history of addiction; history of allergic reaction. In this study, 60 patients scheduled for TEE participated in the study. TEE examinations were performed by two skilled operators who were blinded to the study. All patients were anaesthetized topically in the oropharynx with 10% aerosol solution of lidocaine until the gag reflex was suppressed. After written informed consent, blood pressure, heart rate and pulse oximetry were monitored and recorded. Patients received either IV midazolam (group M, 2 mg bolus) or an infusion of dexmedetomidine (group D, 1 mcg/kg/min, reduced to 0.2 mcg/kg/min after probe insertion). Sedation was assessed using Ramsey sedation score during echocardiography. We recorded blood pressure, SpO(2) and heart rate during echocardiography and recovery. Time-to-discharge, duration of procedure, side effect of drugs, complications and Patients' satisfaction was assessed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201308095381N7
Registration date:2015-01-27, 1393/11/07
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-27, 1393/11/07
Registrant information
Name
Nadia Banihashem
Name of organization / entity
Babol University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 22 38296
Email address
nbanihashem@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor of Research Babol University of Medical Sciences
Expected recruitment start date
2013-06-19, 1392/03/29
Expected recruitment end date
2013-09-11, 1392/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of dexmedetomidine and midazolam for sedation in transesophageal echocardiography.
Public title
A comparison of dexmedetomidine and midazolam for sedation in transesophageal echocardiography.
Purpose
Treatment
Inclusion/Exclusion criteria
exclusion criteria: previous TEE and upper digestive system endoscopic examinations; emergency examinations; pregnancy; mechanical ventilation; patients with psychiatric and emotional disorder;history of addiction;history of allergic reaction.
Inclusion criteria:patients scheduled forTEE; patients with a history of transient cerebral ischaemic attack؛ages of 18-60years
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
Daneshgah Sq - Ganjafrooz Ave
City
babol
Postal code
Approval date
2013-06-11, 1392/03/21
Ethics committee reference number
9235635
Health conditions studied
1
Description of health condition studied
Transient cerebral ischaemic attack
ICD-10 code
G45.9
ICD-10 code description
Transient cerebral ischaemic attack, unspecified
Primary outcomes
1
Description
sedation level
Timepoint
Observation during echography
Method of measurement
Ramsy sedation score
2
Description
patient satisfaction
Timepoint
after echocardiography
Method of measurement
Visual analoge scale
Secondary outcomes
1
Description
Recovery time
Timepoint
end of TEE
Method of measurement
minute
2
Description
nausea and vomiting
Timepoint
End of TEE
Method of measurement
Direct inspection and history
3
Description
Hypoxia
Timepoint
during and after TEE
Method of measurement
pulse oximetry
4
Description
blood pressure
Timepoint
during and after TEE
Method of measurement
Noninvasive cuff measurrment
5
Description
heart rate
Timepoint
during and after TEE
Method of measurement
pulse counting
Intervention groups
1
Description
The first group will received 2 mgmidazolam before the procedure and if needed additional midazolam will be added.
Category
Treatment - Drugs
2
Description
The second group will received an infusion of dexmedetomidine1 mcg/kg/minand reduced to 0.2 mcg/kg/min after probe insertion.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Ruhani Hospital
Full name of responsible person
Dr Nadia Banihashem
Street address
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor of Research Babol University Of Medical Sciences
Full name of responsible person
Dr Amrolah Mostafazadeh
Street address
Daneshgah Square, Ganjafrooz Avenue, Vice-chancellor Of Research
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor of Research Babol 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
Babol University of Medical Sciences
Full name of responsible person
Dr Nadia Banihashem
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 112238296
Fax
Email
nbanihashem@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Nadia Banihashem
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
nbanihashem@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Nadia Banihashem
Position
Assistant Professor of Anesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Ruhani Hospital, Daneshgah Square, Ganjafrooz Avenue
City
Babol
Postal code
Phone
+98 11 1223 8296
Fax
Email
nbanihashem@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)