Protocol summary
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Study aim
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Evaluate the hemodynamic changes in two methods of complete intravenous and inhalation anesthesia in patients candidate for laparoscopy peritoneal catheterization
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Design
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Intervention 1: In the anesthetic inhalation group, for induction, sodium thiopental 4 mg/kg used. Isoflurane 1-2.1% used for maintenance anesthesia.
Intervention 2: In the complete intravenous anesthetic group, for induction, Etomidate 3.0 µg/kg is used. For maintenance of anesthesia, Etomidate 100 µg/kg for the first 10 minutes after induction and followed by 20 µg/kg for up to 10 minutes until the end of the surgery used. Clinical trial phase: 3.
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Settings and conduct
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The aim of the study is to evaluate the hemodynamic changes in two methods of complete intravenous and inhalation anesthesia in patients candidate for laparoscopy peritoneal catheterization
The study conducted in the Emam Khomeini hospital of Tehran city.
Seventy patients were randomly assigned into two groups of complete anesthesia and inhalation anesthesia using random block method.
In this study, the patients, measuring the outcomes of study participants (researchers) or Data Monitoring Committee (analyzers) of the patients unaware of intervention.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Age between 30 to 70 years; ASA class III and IV, exclusion criteria: Complications during or after laparoscopic surgery.
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Intervention groups
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Intervention 1: In the anesthetic inhalation group, for induction, sodium thiopental 4 mg/kg used. Isoflurane 1-2.1% used for maintenance anesthesia.
Intervention 2: In the complete intravenous anesthetic group, for induction, Etomidate 3.0 µg/kg is used. For maintenance of anesthesia, Etomidate 100 µg/kg for the first 10 minutes after induction and followed by 20 µg/kg for up to 10 minutes until the end of the surgery used.
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Main outcome variables
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Hemodynamic changes include systolic and diastolic blood pressure, arterial blood pressure and heart rate.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2017070934978N1
Registration date:
2017-08-17, 1396/05/26
Registration timing:
registered_while_recruiting
Last update:
2018-03-19, 1396/12/28
Update count:
1
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Registration date
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2017-08-17, 1396/05/26
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Tehran University of Medical Sciences
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Expected recruitment start date
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2017-06-22, 1396/04/01
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Expected recruitment end date
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2017-08-22, 1396/05/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Clinical trial comparing the homodynamic changes in two methods of complete intravenous and inhalation anesthetics in patients candidate for laparoscopy peritoneal catheterization
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Public title
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Comparison of hemodynamic changes in both intravenous and inhalation anesthetics
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age between 30 to 70 years
ASA class III and IV
Exclusion criteria:
Complications during or after laparoscopic surgery
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Age
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From 30 years old to 70 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
72
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random method: Block, Random unit: individual, Random Tool: Random Block 4
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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In this study, the patients, measuring the outcomes of study participants (researchers) or Data Monitoring Committee (analyzers) of the patients unaware of intervention.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-12-26, 1395/10/06
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Ethics committee reference number
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IR.TUMS.VCR.REC.1395.1316
Health conditions studied
1
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Description of health condition studied
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End Stage Renal Disease
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ICD-10 code
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N18
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ICD-10 code description
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Chronic kidney disease
Primary outcomes
1
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Description
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Systolic blood pressure
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Timepoint
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First visit the operating room, after the induction, after intubation, before the gas injection into the abdominal cavity, after the injection of the gas into the abdominal cavity and then in the recovery room
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Method of measurement
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Noninvasive blood pressure monitor
2
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Description
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Diastolic blood pressure
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Timepoint
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First visit the operating room, after the induction, after intubation, before the gas injection into the abdominal cavity, after the injection of the gas into the abdominal cavity and then in the recovery room
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Method of measurement
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Noninvasive blood pressure monitor
3
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Description
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Mean arterial blood pressure
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Timepoint
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First visit the operating room, after the induction, after intubation, before the gas injection into the abdominal cavity, after the injection of the gas into the abdominal cavity and then in the recovery room
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Method of measurement
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Noninvasive blood pressure monitor
Secondary outcomes
1
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Description
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Heart rate per minute
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Timepoint
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First visit the operating room, after the induction, after intubation, before the gas injection into the abdominal cavity, after the injection of the gas into the abdominal cavity and then in the recovery room
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Method of measurement
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Monitor
Intervention groups
1
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Description
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Control group: In the complete intravenous anesthetic group, for induction, Etomidate 3.0 µg/kg is used. For maintenance of anesthesia, Etomidate 100 µg/kg for the first 10 minutes after induction and followed by 20 mµg/kg for up to 10 minutes until the end of the surgery is used.
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Category
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Other
2
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Description
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Intervention group: In the anesthetic inhalation group, for induction, sodium thiopental 4 mg/kg is used. Isoflurane 1-2.1% is used for maintenance anesthesia.
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Category
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Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice chancellor for research, Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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Journals of medical sciences
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When the data will become available and for how long
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From 2019
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To whom data/document is available
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Researchers working in academia, science and industry
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Under which criteria data/document could be used
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None
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From where data/document is obtainable
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Researchers
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What processes are involved for a request to access data/document
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Researchers
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Comments
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