After obtaining written informed consent from eligible patients, and getting an approval from Ethics committee of Ahvaz Jundishapur University of Medical Sciences, a double-blind prospective, randomized study will be done to Comparison effect of Propofol-Fentanyl with Propofol-Ketamine for sedation in patients undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP). Inclusion criteria: admitted patients for diagnostic and therapeutic ERCP in Imam Khomeini hospital; 18 to 65 years old; anesthesia risk of 1, 2 (According to American society of anesthesiologist's classification).
Exclusion criteria: patient refuse; under 18 and over 65 years old; a history of drug abuse; sensitivity to egg; contraindication of Fentanyl or Ketamine. Patients will be randomly allocated into two groups according to table of random numbers. Groups "one" and "two" will receive intravenous Propofol 0.5 mg/kg with intravenous Fentanyl 1 µg/kg and intravenous Propofol 0.5 mg/kg with intravenous Ketamine 0.5 mg/kg, respectively. Sedation score of patient in 4 different times, during procedure, according to Ramsay sedation score is measured. Postoperative pain and nausea and vomiting will measured at 1 hour after procedure
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014031316976N1
Registration date:2014-04-15, 1393/01/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-04-15, 1393/01/26
Registrant information
Name
Sanaz Noorizade
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 61 1358 9698
Email address
noorizade.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz University of Medical Sciences
Expected recruitment start date
2014-06-15, 1393/03/25
Expected recruitment end date
2014-12-15, 1393/09/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of Propofol-Fentanyl with Propofol-Ketamine for sedation in patients undergoing ERCP
Public title
Comparison effect of Propofol-Fentanyl with Propofol-Ketamine for sedation in patients undergoing ERCP
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: admitted patients for diagnostic and therapeutic ERCP in Imam Khomeini hospital; 18 to 65 years old; anesthesia risk of 1, 2 (According to American society of anesthesiologist's classification).
Exclusion criteria: patient refuse; under 18 and over 65 years old; a history of drug abuse; sensitivity to egg; contraindication of Fentanyl or Ketamine.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
98
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
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Fluoroscopy of Biliary and Pancreatic Ducts using Low Osmolar Contrast
Primary outcomes
1
Description
Sedation Score
Timepoint
Four times, during procedure
Method of measurement
Ramsay Sedation Score
Secondary outcomes
1
Description
Pain
Timepoint
One hour after procedure
Method of measurement
Visual Analogue Scale
2
Description
Nausea
Timepoint
One hour after procedure
Method of measurement
Zero for not having nausea, One for mild nausea, Two for moderate nausea and Three for sever nausea
3
Description
Vomiting
Timepoint
One hour after procedure
Method of measurement
Zero for the patients not experiencing vomiting, 1 for the little vomiting, 2 for vomiting gastric contents and 3 for vomiting food particles.
Intervention groups
1
Description
Drugs:
1-Propofol:
Dose: 0.5mg/kg
Number of using: Once
Factory name: Astra Zeneca
Country's Name:India
Location prescribed: Intravascular
Administration time: At the beginning of the procedure
2-Ketamine:
Dose: 0.5mg/kg
Number of using: Once
Factory name: Rotexmedica
Manufacturing Country's Name: Germany
Location prescribed: Intravascular
Administration time: At the beginning of the procedure
Category
Treatment - Drugs
2
Description
Drugs:
1-Propofol:
Dose: 0.5mg/kg
Number of using: Once
Factory name: Astra Zeneca
Country's Name:India
Location prescribed: Intravascular
Administration time: At the beginning of the procedure
2-Fentanyl
Dose: 1mcg/kg
Number of using: Once
Factory name: Chekad Manufacturing
Country's name: Iran
Location prescribed: Intravascular
Administration time: At the beginning of the procedure