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Investigation of hemodynamic effects of two combinations of Propofol-Fentanyl and Propofol- Lidocaine in patients undergoing upper endoscopy

Protocol summary

Study aim
By understanding the hemodynamic effects of Propofol-Fentanyl and Propofol-Lidocaine in patients undergoing endoscopy, a combination can be used during endoscopy that makes patients less prone to hemodynamic changes.
Design
Clinical trial with 2 groups of Fentanyl and Lidocaine, with parallel groups, single-blind, randomized, phase 3 on 198 patients. R block statistical software is used for block randomization.
Settings and conduct
The present study will be performed in Afzalipour Hospital in Kerman. Hemodynamics (blood pressure, heart rate, arterial blood oxygen saturation and respiration rate) once before drug administration and once after drug injection before endoscopy and then every 5 minutes until completion of work through the patient monitoring system are checked and registered. The patient's tolerance should then be checked which is characterized by gagging or shaking hands. After the endoscopy, we check which group of drugs the patients wake up earlier. In order to blind one-way study, all data entry measures will be performed by a person unaware of the patient group.
Participants/Inclusion and exclusion criteria
Inclusion criteria include patients undergoing upper endoscopy aged 20 to 40 years.Exclusion criteria included patient addiction, hypertension, hyperlipidemia, thyroid disease and any other comorbidities, also contraindications to Lidocaine use, including patients with G6PD, myasthenia gravis, methemoglobinemia, heart block, and Wolff-Parkinson-White syndrome, Adams-Stokes syndrome and low blood potassium levels.
Intervention groups
All patients were given 0.05 mg / kg Midazolam and 40 mg / min Propofol and randomly given 1 ug / kg Fentanyl to the first group and 1.5 mg / kg intravenous Lidocaine to the second group 90 seconds before each procedure.
Main outcome variables
Reduction of blood pressure fluctuations, heart rate, respiration rate, etc. during upper endoscopy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20101220005426N11
Registration date: 2021-08-20, 1400/05/29
Registration timing: prospective

Last update: 2021-08-20, 1400/05/29
Update count: 0
Registration date
2021-08-20, 1400/05/29
Registrant information
Name
Mehdi Ahmadinejad
Name of organization / entity
Anesthesiology department, Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 0223 5011
Email address
m.ahmadinejad@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of hemodynamic effects of two combinations of Propofol-Fentanyl and Propofol- Lidocaine in patients undergoing upper endoscopy
Public title
Hemodynamic effects of Propofol-Fentanyl and Propofol-Lidocaine in patients undergoing endoscopy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing upper endoscopy Patients aged 20 to 40 years
Exclusion criteria:
Addiction High blood pressure Hyperlipidemia Underlying disease, including thyroid disease, etc. Patients with G6PD disorder Myasthenia gravis methemoglobinemia Heart block Wolff-Parkinson-White syndrome Adams-Stokes syndrome Low blood potassium levels
Age
From 20 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 198
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize people to the two groups, the block randomization method is used in such a way that 4 blocks are used. In each block of 4, 2 people are assigned to the first group and 2 people to the second group. R statistical software is used for random block allocation
Blinding (investigator's opinion)
Single blinded
Blinding description
In order to blind the one side of the study, all data recording measures will be performed by a person unaware of the patient group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Vice chancellor for research, Kerman University of Medical Sciences, Jahad Blvd, Somayye Crossroads, Shariaati St, Kerman
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2021-05-03, 1400/02/13
Ethics committee reference number
IR.KMU.REC.1400.104

Health conditions studied

1

Description of health condition studied
upper endoscopy
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Blood pressure
Timepoint
Checking of blood pressure once before drug administration and once after drug injection before endoscopy and then every 5 minutes until completion of work
Method of measurement
Patient monitoring system

2

Description
Heart rate
Timepoint
Checking of heart rate once before drug administration and once after drug injection before endoscopy and then every 5 minutes until completion of work
Method of measurement
Patient monitoring system

3

Description
Arterial blood oxygen saturation
Timepoint
Checking of arterial blood oxygen saturation once before drug administration and once after drug injection before endoscopy and then every 5 minutes until completion of work
Method of measurement
Patient monitoring system

4

Description
Respiratory rate
Timepoint
Checking of respiratory rate saturation once before drug administration and once after drug injection before endoscopy and then every 5 minutes until completion of work
Method of measurement
Patient monitoring system

5

Description
Gag reflex
Timepoint
During upper endoscopy
Method of measurement
Doctor checkup

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group: after receiving 0.05 mg / kg Midazolam and 40 mg / min Propofol maintenance, we give the first group 1 ug / kg Fentanyl (from Abu Reihan company) with the brand name of Fanijekt 90 seconds before each procedure.
Category
Rehabilitation

2

Description
Second intervention group: After receiving 0.05 mg / kg Midazolam and 40 mg / min Propofol maintenance, we give the second group 1.5 mg / kg intravenous Lidocaine 90 seconds before each procedure.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Bahonar Hospital, Kerman
Full name of responsible person
Mehdi Ahmadinejad
Street address
Shahid Bahonar Hospital, Qarani St, Valiasr Crossroads, Shariaati St, Kerman
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
mehdia50@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Abbas Pardakhti
Street address
Vice chancellor for research of Kerman University of Medical Sciences, Jahad Blvd, Somayye Crossroads, Shariaati St, Kerman
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3719
Email
KMU_RESEARCH@YAHOO.COM
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Mehdi Ahmadinejad
Position
Assistant Professor- Fellow of Intensive Care
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Bahonar Hospital, Qarani St, Valiasr Crossroads, Shariaati St, Kerman
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
mehdia50@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mehdi Ahmadinejad
Position
Position Assistant Professor- Fellow of Intensive Care
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Bahonar Hospital, Qarani St, Valiasr Crossroads, Shariaati St, Kerman
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
mehdia50@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mehdi Ahmadinejad
Position
Assistant Professor- Fellow of Intensive Care
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Bahonar Hospital, Qarani St, Valiasr Crossroads, Shariaati St, Kerman
City
Kerman
Province
Kerman
Postal code
7613747181
Phone
+98 34 3223 5011
Email
mehdia50@gmail.com

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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