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The sedation effect of midazolam-fentanyl and midazolam-propofol combination in patients with elective upper gastrointestinal endoscopy in Ali ebne Abitaleb Hospital, Zahedan, in 2018

Protocol summary

Study aim
The sedation effect of midazolam-fentanyl and midazolam-propofol combination in patients with elective upper gastrointestinal endoscopy in Ali ebne Abitaleb Hospital, Zahedan, in 2018
Design
Selection and assignment of samples to each treatment group is done by random blocking method. The number of cards in each block will be in the case and control groups, the arrangement of each card of the groups in the block, taking into account the random order with the examples of the permutations, will be arranged. Thus, according to the sample size, 140 people (70 Midazolam + Fentanyl and 70 Midazolam + Propofol) will be identified. Also in this study Patients, Anesthetist, Gastroenterologist are unaware of the allocation of study groups.
Settings and conduct
After obtaining written consent, patients who are referred for elective endoscopy are divided into two groups: midazolam + fentanyl (F), midazolam, mcg / kg 15, fentanyl 0.15 mg / kg, and midazolam + propofol (P ) Midazolam 15mcg / kg and Propofol 1mg / kg were given intravenously.
Participants/Inclusion and exclusion criteria
inclusion criteria: patient candidated for upper GI endoscopy; age 20-70 years old; ASA class ≤3. Exclusion criteria: heart disease AS، IHD ، HTN،(HF EF<30%); liver disease (Child-Pugh classification C); renal disease (GFR<60%); lack of patient cooperation; psychiatric disease (Major Depression, Mania, Psychosis); SBP<90; addiction; emergent endoscopy; allergy to egg and soybean.
Intervention groups
1- The group receiving midazolam + fentanyl 2. The group receiving midazolam + propofol
Main outcome variables
Sedation; satisfaction; hemodynamic instability; apnea

General information

Reason for update
Acronym
ZSGIE
IRCT registration information
IRCT registration number: IRCT20190714044207N1
Registration date: 2019-07-25, 1398/05/03
Registration timing: retrospective

Last update: 2019-07-25, 1398/05/03
Update count: 0
Registration date
2019-07-25, 1398/05/03
Registrant information
Name
Sakineh Sheikh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3343 4621
Email address
sakine.sheikh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2019-03-19, 1397/12/28
Actual recruitment start date
2017-03-21, 1396/01/01
Actual recruitment end date
2019-03-19, 1397/12/28
Trial completion date
2019-03-19, 1397/12/28
Scientific title
The sedation effect of midazolam-fentanyl and midazolam-propofol combination in patients with elective upper gastrointestinal endoscopy in Ali ebne Abitaleb Hospital, Zahedan, in 2018
Public title
The sedation effect of midazolam-fentanyl and midazolam-propofol combination in patients with elective upper gastrointestinal endoscopy in Ali ebne Abitaleb Hospital, Zahedan, in 2018
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient candidated for upper GI endoscopy 20-70 years old ASA class ≤3
Exclusion criteria:
Heart disease AS، IHD ، HTN،(HF EF<30%) Liver disease (Child-Pugh classification C) Renal disease (GFR<60%) Lack of patient cooperation Psychiatric Disease (Major Depression, Mania, Psychosis) SBP<90 Addiction Emergent endoscopy Allergy to egg and soybean
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 140
Actual sample size reached: 140
Randomization (investigator's opinion)
Randomized
Randomization description
Selection and assignment of samples to each treatment group is done by random blocking method. The number of cards in each block will be in the case and control groups, the arrangement of each card of the groups in the block, taking into account the random order with the examples of the permutations, will be arranged.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients, Anesthetist, Gastroenterologist are unaware of the allocation of study groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
ZAUMS Main campus, Zahedan, Sistan and Baluchestan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2019-01-26, 1397/11/06
Ethics committee reference number
IR.ZAUMS.REC.1397.244

Health conditions studied

1

Description of health condition studied
The sedative effect of the medication on endoscopic digestive system
ICD-10 code
R10
ICD-10 code description
Abdominal and pelvic pain

2

Description of health condition studied
The sedative effect of the medication on endoscopic digestive system
ICD-10 code
R19
ICD-10 code description
Other symptoms and signs involving the digestive system and abdomen

Primary outcomes

1

Description
Sedation of drugs in both groups before and after endoscopy
Timepoint
From the start of the drug (time 0) and every 5 minutes, it is recorded until the patient is transferred to the recovery room.
Method of measurement
Ramsay sedation score (0-5)

2

Description
The number of respiration in both groups before and after endoscopy
Timepoint
From the start of the drug (time 0) and every 5 minutes, it is recorded until the patient is transferred to the recovery room.
Method of measurement
Vital signs Monitor device

3

Description
The number of heart rate in both groups before and after endoscopy
Timepoint
From the start of the drug (time 0) and every 5 minutes, it is recorded until the patient is transferred to the recovery room.
Method of measurement
Vital signs Monitor device

4

Description
Blood Pressure in both groups before and after endoscopy
Timepoint
From the start of the drug (time 0) and every 5 minutes, it is recorded until the patient is transferred to the recovery room.
Method of measurement
Vital signs Monitor device

5

Description
Arterial oxygen saturation in both groups before and after endoscopy
Timepoint
From the start of the drug (time 0) and every 5 minutes, it is recorded until the patient is transferred to the recovery room.
Method of measurement
Vital signs Monitor device

Secondary outcomes

1

Description
Comparison of vital signs after endoscopy
Timepoint
When the patient is transferred to the recovery room
Method of measurement
Monitoring device of vital signs

2

Description
The satisfaction of sefation of two drug regimens
Timepoint
After Endoscopy End
Method of measurement
Anesthesiology Resident Skill and Experience

Intervention groups

1

Description
Intervention group: IV infusion of midazolam + fentanyl (F), midazolam, mcg / kg 15, fentanyl 0.15 mg / kg
Category
Treatment - Drugs

2

Description
Intervention group:IV infusion of midazolam + propofol (P ) Midazolam 15mcg / kg and Propofol 1mg / kg
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali ebne Abitaleb Hospital, Zahedan
Full name of responsible person
Sakineh Sheikh
Street address
Salamat Blvd., Persian Gulf Highway, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
sakine.sheikh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Doctor Nour Mohamad Bakhshani
Street address
ZAUMS Main campus, Zahedan, Sistan and Baluchestan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
sakine.sheikh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Doctor Sakineh Sheikh
Position
Anesthesiology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Salamat Blvd., Persian Gulf Highway, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
sakine.sheikh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Sakineh Sheikh
Position
Anesthesiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Third Intersection, No. 12 Shahid Barfi street, Shahid Barfi Ave
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3343 4621
Fax
Email
mmahjoubifard@zaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Sakineh Sheikh
Position
Anesthesiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Third Intersection, No. 12 Shahid Barfi street, Shahid Barfi Ave
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3343 4621
Fax
Email
mmahjoubifard@zaums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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