Comparison of analgesic and sedative effect of combined propofol plus fentanyl and propofol plus ketamine in patients undergoing endoscopic retrograde of cholangiopancreatography
The purpose of this study is comparison of analgesic and sedative effect of combined propofol plus fentanyl and propofol plus ketamine in patients undergoing endoscopic retrograde of cholangiopancreatography. In a clinical trial, 60 patients 18 to 80 years undergoing endoscopic retrograde of cholangiopancreatography were randomly divided into two equal groups. Addicted and severe heart failure patients are excluded. The Intervention group receives 1 mg midazolam and 0.5 mg/kg ketamine and the control group receives midazolam 1 mg and fentanyl 50 to 100 micrograms before endoscopic retrograde of cholangiopancreatography .In both groups 0.5 mg / kg propofol as a rescue bolus dose and then followed by 75microgram / kg / min infusion are administrated. Patients, anesthesiologist, endoscopist, and patients’ examiner are unaware of the regimen. Depth of sedation (based on ramsay scale), blood pressure, heart rate, and oxygen saturation of peripheral blood are recorded since starting medication every 2 minutes to 10 minutes and then every 5 minutes to end of procedure are recorded. Time of awakening based on Aldret score (equal to or greater than 9) and pain intensity based on Visual Analogue are recorded. Endoscopist and patient satisfaction after procedure are investigated based on the Likert scale.
General information
Acronym
ERCP:endoscopic retrograde of cholangiopancreatography
IRCT registration information
IRCT registration number:IRCT201410187752N6
Registration date:2014-12-09, 1393/09/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-09, 1393/09/18
Registrant information
Name
Parviz Amri Maleh
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 8296
Email address
pamrimaleh@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research of Babol University of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of analgesic and sedative effect of combined propofol plus fentanyl and propofol plus ketamine in patients undergoing endoscopic retrograde of cholangiopancreatography
Public title
Comparison of analgesic and sedative effect of combined propofol plus fentanyl and propofol plus ketamine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 18-80 years; ASA class ≤ 3 Exclusion criteria: age <18 years or> 80 years; Heart disease (arrhythmias, Aortic Stenosis, Ischemic Heart Disease,Heart failure) ; liver disease (Child-Pugh classification C); drug addiction.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
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
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-chancellor of research of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences,Gangafrooz Street, Daneshgah Square, Babol, Mazandaran, Iran
City
Babol
Postal code
471764136
Approval date
2014-10-12, 1393/07/20
Ethics committee reference number
4709
Health conditions studied
1
Description of health condition studied
Sedation
ICD-10 code
y48.2
ICD-10 code description
Other and unspecified general anaesthetics
Primary outcomes
1
Description
Sedation
Timepoint
Every 2 minutes till 10 minutes and then every 5 minutes till 1 houre
Method of measurement
Ramsay Sedation Scale
2
Description
Pain
Timepoint
Every 2 minutes till 10 minutes and then every 5 minutes till 1 houre
Method of measurement
Visual Analoge Scale
Secondary outcomes
1
Description
Blood pressure
Timepoint
Every 2 minutes till 10 minutes and then every 5 minutes till 1 houre
Method of measurement
sphygmomanometer
2
Description
Respiratory Rate
Timepoint
Every 2 minutes till 10 minutes and then every 5 minutes till 1 houre
Method of measurement
observation
Intervention groups
1
Description
The Intervention group receives 1 mg midazolam and0.5 mg/kg ketamine before ERCP and 0.5 mg / kg propofol as a rescue bolus dose then followed by 75microgram / kg / min infusion
Category
Treatment - Drugs
2
Description
the control group receives midazolam 1 mg and fentanyl 50 to 100 micrograms before ERCP and 0.5 mg / kg propofol as a rescue bolus dose and then followed by 75microgram / kg / min infusion