Comparison of hemodynamic and respiratory effects of premedication with fentanyl or fentanyl and midazolam during anesthesia for endoscopic retrograde cholangiopancreatography
Despite all methods used for the anesthesia of the patients undergoing ERCP, complete immobility required for an accurate procedure would not happen unless hypnotic agents such as propofol are used. On the other hand, administration of propofol in combination with other medications such as opioids or benzodiazepines could be associated with increased risk of apnea and hemodynamic instability, especially in the elderly or those with accompanying diseases. In this randomized, double blinded and single center study, the primary outcome was comparing the hemodynamic and respiratory effects of premedication with fentanyl (control) or fentanyl and midazolam (intervention) during anesthesia for endoscopic retrograde cholangiopancreatograph. Inclusion criteria are the patients with ASA class I-III who will undergo endoscopic retrograde cholangiopancreatography(ERCP). Exclusion criteria from the study are: Emergency ERCP, Liver or kidney diseases, previous history of sedatives or tranquilizers. The respiratory impacts including the emergence of the apnea before and after the intervention will be compared between two groups. The selected premedicatoin combination from the study would provide more appropriate and safer anesthesia for the patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016031120795N2
Registration date:2016-04-29, 1395/02/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-29, 1395/02/10
Registrant information
Name
Samad Golzari
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3556 6183
Email address
golzaris@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of hemodynamic and respiratory effects of premedication with fentanyl or fentanyl and midazolam during anesthesia for endoscopic retrograde cholangiopancreatography
Public title
Premedication with fentanyl or fentanyl and midazolam for endoscopic retrograde cholangiopancreatography
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients with ASA class I-III who will undergo endoscopic retrograde cholangiopancreatography(ERCP). Exclusion criteria: Emergency ERCP; Liver or kidney diseases; previous history of sedatives or tranquilizers.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2015-11-09, 1394/08/18
Ethics committee reference number
TBZMED.REC.94.713
Health conditions studied
1
Description of health condition studied
Cholelithiasis
ICD-10 code
K80
ICD-10 code description
Any condition listed in K80.2 with acute cholecystitis
Primary outcomes
1
Description
respiratory effects
Timepoint
Before and instantly after intervention
Method of measurement
Apnea presence
Secondary outcomes
1
Description
Hemodynamic effects
Timepoint
After intervention
Method of measurement
Blood pressure and Heart rate measuring
Intervention groups
1
Description
Intervention group premedication with fentanyl 1 microgram/kg before anesthesia induction
Category
Treatment - Drugs
2
Description
Control group premedication with fentanyl 1 microgram/kg and midazolam 0.02 mg/kg before anesthesia induction
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Samad Eslam Jamal Golzari
Street address
Imam Reza Hospital, Golgasht St., Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Samad Eslam Jamal Golzari
Street address
Imam Reza Hospital, Golgasht St., Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Samad Golzari
Position
Assistant Professor
Other areas of specialty/work
Street address
Imam Reza Hospital, Golgasht St., Tabriz
City
Tabriz
Postal code
Phone
+98 41 3556 6183
Fax
Email
golzaris@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Samad Eslam Jamal Golzari
Position
MD, Assisstant Professor
Other areas of specialty/work
Street address
Imam Reza Hospital, Golgasht St., Tabriz
City
Tabriz
Postal code
Phone
+98 914 115 1894
Fax
Email
golzaris@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Samad Eslam Jamal Golzari
Position
MD, Assisstant Professor
Other areas of specialty/work
Street address
Imam Reza Hospital, Golgasht St., Tabriz
City
Tabriz
Postal code
Phone
+98 41 3556 6183
Fax
Email
golzaris@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)