Comparing the effectiveness of intravenous and sublingual administration of midazolam for sedation of patients candidates for upper gastrointestinal endoscopy
Determining and comparing the effectiveness of intravenous and sublingual administration of midazolam for sedation in patients who are candidates for upper gastrointestinal endoscopy.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 66 patients. Random allocation software version 1.0 under Windows is used for randomization.
Settings and conduct
This study is conducted on patients who were admitted for endoscopy in the endoscopy department of Shahid Sadoughi Hospital in Yazd. Before endoscopy, drugs are given to the patient and then the level of sedation is evaluated. Also, after the endoscopy, the patient is evaluated in terms of pain/discomfort and satisfaction. This study is double-blind, and neither the researcher nor the patient knows the type of drug prescribed, so the drugs are coded in two identical packages, and the third person gives the drug to the patient based on the specified code.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Adult patients who are candidates for upper gastrointestinal endoscopy who undergo diagnostic endoscopy for the first time. Non-inclusion criteria: Existence of moderate or severe systemic disease; History of taking sedatives and anti-anxiety drugs; Addiction to opioids, sedatives or psychotropic drugs; dissatisfaction to participate in the study
Intervention groups
Intervention group1: Before the procedure, patients are given 2.5 mg of intravenous midazolam and 1 ml of normal saline sublingually. Intervention group 2: Patients are given one milliliter of normal intravenous saline and 5 mg of midazolam sublingually before the procedure.
Comparing the effectiveness of intravenous and sublingual administration of midazolam for sedation of patients candidates for upper gastrointestinal endoscopy
Public title
Comparing the effectiveness of intravenous and sublingual administration of midazolam for sedation of patients who are candidates for upper gastrointestinal endoscopy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patients who are candidates for upper gastrointestinal endoscopy who undergo diagnostic endoscopy for the first time
Exclusion criteria:
Existence of moderate to severe systemic disease
history of using of sedative or tranquilizer drugs
addiction to opioids or any sedative or psychotropic drugs
disagreement for cooperation in this study
Age
From 15 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are randomly divided into two groups of 40 people in such a way that using the Random allocation software version 1.0 under Windows, we generate a random sequence using a simple random allocation method. In this table, numbers from 1 to 80 are specified and each number is assigned to an intervention group (A or B). Number 1 is assigned to the first qualified person, second person is number 2, and so on up to 80 patients. becomes Then based on the random allocation list prepared and by the software, it is determined which group A or B each person is placed in. All patients receive drugs and placebo (normal saline) both intravenously and sublingually. Each drug is placed in a package and the packages are coded and based on the table of random numbers and specified code, the drug and placebo are given to the patients by a third person who is not involved in evaluating the patients and recording the results.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients themselves and the researcher are not aware of the dose and method in which the patient received the drug, as all patients receive the drug and placebo (normal saline) both intravenously and sublingually. They do not know in which method the drug and which placebo is prescribed for each patient. Each drug is placed in a package and the packages are coded, and based on the table of random numbers and specified code, the drug is given to the patients by a third person who is not involved in evaluating the patients and recording the results.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi University of Medical Sciences
Street address
Central building of Yazd University of Medical Sciences, Bahonar Square
City
Yazd
Province
Yazd
Postal code
8915887857
Approval date
2018-12-26, 1397/10/05
Ethics committee reference number
IR.SSU.MEDICINE.REC.1397.185
Health conditions studied
1
Description of health condition studied
The effect of medicine on the level of sedation, pain and discomfort and satisfaction of patients who are candidates for upper gastrointestinal endoscopy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The level of sedation
Timepoint
Before endoscopy
Method of measurement
A sedation score from 1 to 6 is given to each patient. In this way, score 1: the patient is awake, anxious and restless. Score 2: The patient is awake, alert, calm and cooperative. Score 3: The patient is awake and obeys orders. Score 4: The patient is asleep and responds quickly to stimulation (gentle blow to the forehead or loud sound stimulation). Score 5: The patient is asleep and gives a weak response to stimulation (gentle blow to the forehead area or loud sound stimuli). Score 6: The patient is asleep and does not respond to stimulation (gentle blow to the forehead area) or loud sound.
Secondary outcomes
1
Description
The level of Pain/discomfort
Timepoint
Before endoscopy
Method of measurement
Pain/discomfort Score(0-10)
2
Description
The level of satisfaction that gave a score of 1 to 10 for each patient.
Timepoint
Before endoscopy
Method of measurement
Satisfaction Score(0-10)
Intervention groups
1
Description
Intervention group: Before the procedure, patients are given 2.5 mg of intravenous midazolam and 1 ml of normal saline sublingually
Category
Treatment - Drugs
2
Description
Intervention group: Patients are given one milliliter of normal intravenous saline and 5 mg of midazolam sublingually before the procedure.