Protocol summary

Summary
In this study we compared Entonox effectiveness of sedation for Cardioversion with standard intravenous sedation, midazolam & fentanyl. Inclusion criteria was: age over 18 years, symptomatic Tachydysrythmia. Exclusion criteria was: any situation that cause air entrapment in body. Forty four patients with symptomatic Tachydysrythmia divided in two groups randomly. Midazolam plus Fentanyl administered intravenously in first group and Entonox administered with demand valve mask in second group. Time of sedation, time of end of sedation, complications was recorded. Level of sedation noted according to Richmond sedation and analgesia score and at the end of sedation, pain score recorded in each group with visual analogue scale.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201202269147N1
Registration date: 2014-05-13, 1393/02/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-05-13, 1393/02/23
Registrant information
Name
Sina Saghari
Name of organization / entity
Ahvaz Jundishapur University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1375 7129
Email address
saghari.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz University of Medical Sciences
Expected recruitment start date
2013-03-21, 1392/01/01
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparison the Effectiveness between Entonox and Midazolam-Fentanyl in Sedation for Cardioversion in patients with Tachydysrythmia
Public title
Sedation for Cardioversion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age over 18 years; symptomatic Tachydysrythmia Exclusion criteria: Drug sensitivity; pneumothorax; small bowel obstruction; chronic obstructive pulmonary disease; head trauma with decreased level of consciousness; Maxiofacial Injury; air emboli; inner ear infection
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Jundishapur University of Medical sciences, University City, Ahvaz, Khuzestan, Iran
City
Ahvaz
Postal code
Approval date
2012-06-21, 1391/04/01
Ethics committee reference number
ETH-534

Health conditions studied

1

Description of health condition studied
Sedation for Cardioversion
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain
Timepoint
After Sedation
Method of measurement
Visual Analogue Scale

2

Description
Sedation Level
Timepoint
During Sedation
Method of measurement
Richmond analgesia and sedation Scale

Secondary outcomes

1

Description
Respiratory arrest
Timepoint
During sedation
Method of measurement
Patient Respiration observe

2

Description
More Doses
Timepoint
During sedation
Method of measurement
More than primery standard dose

3

Description
Time of Sedation
Timepoint
From onset of sedation untill return to primery level of consiousness
Method of measurement
Minutes

Intervention groups

1

Description
Control group sedated with Midazolam (0.15 milligrams per kilograms) plus Fentanyl (1.5 micrograms per kilograms)
Category
Treatment - Drugs

2

Description
Intervention group sedated with Entonox by demand valve mask.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam khomeini Hospital
Full name of responsible person
Sina Saghari
Street address
Shahid Ahvazian avenue, 24 metri street, Ahvaz, Khuzestan, Iran
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Miss. Jaderi
Street address
Vice Chancellor for Research and Technology, Jundishapur University of Medical Sciencs, University city, Ahvaz, Khuzestan, Iran
City
Ahvaz
Grant name
Grant code / Reference number
U91080
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Sina Saghari
Position
Resident
Other areas of specialty/work
Street address
Shahid Ahvazian avenue, 24metri street, Ahvaz, khuzestan, Iran
City
Ahvaz
Postal code
Phone
+98 61 1222 9166
Fax
Email
Saghari.s@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Kambiz Masoumi
Position
Associate professor
Other areas of specialty/work
Street address
Shahid Ahvazian avenue, 24metri street, Ahvaz, Khuzestan, Iran
City
Ahvaz
Postal code
6193673166
Phone
+98 61 1222 9166
Fax
Email
kami_masoumi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Sina Saghari
Position
Resident
Other areas of specialty/work
Street address
Shahid Ahvazian avenue, 24metri street, Ahvaz, Khuzestan, Iran
City
Ahvaz
Postal code
Phone
Fax
Email
Saghari.s@ajums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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