Comparative study on the sedative effect of ketamine, magnesium sulfate and propofol in upper endoscopy
Design
Randomized clinical trial, with three arm parallel group of 201 patients, will be enrolled between January 2020 and August 2020.
Settings and conduct
In this research, 201 eligible patients need to perform endoscopy referring to Qom gastroenterology clinic will be selected. Then, patients by block randomization will be divided randomly into three interventions groups. The first intervention group will receive propofol and second intervention group will receive ketamine and the third group will receive ketamine and magnesium sulfate. Patients will not be aware of the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients aged more than 12 years, need to perform endoscopy. Exclusion criteria: American Society of Anesthesiologists (ASA) score 3 or more, history of allergy to used drugs.
Intervention groups
Intervention group 1: Intravenous midazolam 0.03 mg/kg + Intravenous propofol 1 mg/kg, before endoscopy. Intervention group 2: Intravenous midazolam 0.03 mg/kg + intravenous ketamine 0.5 mg/kg, before endoscopy. Intervention group 3: Intravenous midazolam 0.03 mg/kg + intravenous ketamine 0.3 mg/kg + intravenous magnesium sulfate 2 gr, before endoscopy
Main outcome variables
Physician's and patient's satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161205031252N12
Registration date:2020-02-06, 1398/11/17
Registration timing:registered_while_recruiting
Last update:2020-02-06, 1398/11/17
Update count:0
Registration date
2020-02-06, 1398/11/17
Registrant information
Name
Ahmad Hormati
Name of organization / entity
Qom university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 25 3612 2053
Email address
hormatia@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-17, 1398/10/27
Expected recruitment end date
2020-07-17, 1399/04/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study on the sedative effect of ketamine, magnesium sulfate and propofol in upper endoscopy
Public title
Comparative study on the sedative effect of ketamine, magnesium sulfate and propofol in endoscopy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged more than 12 years
Exclusion criteria:
History of allergy to medications
ASA physical status classification system more than 3
Age
From 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
201
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be assigned to three groups of interventions by block randomization. For this purpose blocks of size 6 will be used. 34 blocks will include. To hide the random allocation, the numbered dark envelopes will be used, in which the group name is specified in the random sequence generated. Then, according to the order of entering samples, for the first patient the envelope number one is opened and the group will be identified until the end
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and endoscopist does not know the allocation and drugs are injected into the patient by an anesthesiologist.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Qom University of Medical Sciences
Street address
No. 83, 4th alley, 1.1 alley, Safashahr Blvd
City
Qom
Province
Ghoum
Postal code
3716987366
Approval date
2019-11-05, 1398/08/14
Ethics committee reference number
IR.MUQ.REC.1398.103
Health conditions studied
1
Description of health condition studied
Diseases of upper digestive system which need endoscopy
ICD-10 code
K25
ICD-10 code description
Gastric ulcer
2
Description of health condition studied
Diseases of upper digestive system which need endoscopy
ICD-10 code
K22.7
ICD-10 code description
Barrett's esophagus
Primary outcomes
1
Description
Physician's satisfaction of the adequacy of sedation for performing endoscopy
Timepoint
Immediately after completing the endoscopy
Method of measurement
Comfort score
2
Description
Patient's satisfaction of the adequacy of sedation for performing endoscopy
Timepoint
Immediately after completing the endoscopy
Method of measurement
Comfort score
3
Description
Sedation response score
Timepoint
Immediately after completing the endoscopy
Method of measurement
Ramsay sedation scale
Secondary outcomes
1
Description
Recovery time
Timepoint
At the time of leaving recovery
Method of measurement
Time recording
Intervention groups
1
Description
Control group: Amp midazolam,Daroopakhsh, 0.03 mg/kg, once, intravenous, before endoscopy + Amp propofol, Daroopakhsh, 1 mg/kg, once, intravenous, before endoscopy
Category
Treatment - Drugs
2
Description
Intervention group 1: Amp midazolam, Daroopakhsh, 0.03 mg/kg, once, intravenous, before endoscopy + Amp ketamine, Daroopakhsh, 0.5 mg/kg, once, intravenous, before endoscopy
Category
Treatment - Drugs
3
Description
Intervention group 2: Amp midazolam, Daroopakhsh, 0.03 mg/kg once, intravenous, before endoscopy + Amp ketamine, Daroopakhsh, 0.3 mg/kg once, intravenous, before endoscopy + Amp magnesium sulfate, Daroopakhsh, 2 gr, once, intravenous, before endoscopy