History
# Registration date Revision Id
2 2018-02-18, 1396/11/29 40727
1 2017-08-17, 1396/05/26 26579
Changes made to previous revision
This is the first revision

Protocol summary

Summary
Objectives: The aim of the present study is to evaluate the hemodynamic changes in two methods of complete intravenous and inhalation anesthesia in renal transplant patients with peritoneal catheterization with laparoscopy. Design: Randomized clinical trial. Setting and conduct: Seventy patients were randomly assigned into two groups of complete anesthesia and inhalation anesthesia using random block method. In the anesthetic inhalation group, for induction, sodium thiopental 4 mg/kg used. Isoflurane 1-2.1% used for maintenance anesthesia. In the complete intravenous anesthetic group, for induction, Etomidate 3.0 mg/kg is used. For maintenance of anesthesia, Etomidate 100 mg/kg for the first 10 minutes after induction and followed by 20 mg/kg for up to 10 minutes until the end of the surgery used. In both groups, the hemodynamic changes reported at the first visit to the operating room, after the induction, after intubation, before the injection into the abdominal cavity, after the injection of the gas into the abdominal cavity and then in the recovery room. The population studied: Renal patients who are candidates for peritoneal catheterization with a laparoscope. Inclusion criteria: Age between 18 to 80 years; ASA class I and II exclusion criteria: Complications during or after laparoscopic surgery Interventions: The intervention group is anesthetic inhalation and in the control group, a complete intravenous anesthetic is used. Main outcome measures (variables): Hemodynamic changes include systolic and diastolic blood pressure, arterial blood pressure and heart rate.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017070934978N1
Registration date: 2017-08-17, 1396/05/26
Registration timing: registered_while_recruiting

Last update:
Update count: 1
Registration date
2017-08-17, 1396/05/26
Registrant information
Name
Mojgan Rahimi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 84426391
Email address
mrahimi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-08-22, 1396/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial comparing the homodynamic changes in two methods of complete intravenous and inhalation anesthetics in renal transplant patients with peritoneal catheterization with laparoscopy
Public title
Comparison of hemodynamic changes in both intravenous and inhalation anesthetics
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age between 18 to 80 years; ASA class I and II exclusion criteria: Complications during or after laparoscopic surgery.
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshvarz Blvd
City
Tehran
Postal code
Approval date
2016-12-26, 1395/10/06
Ethics committee reference number
IR.TUMS.VCR.REC.1395.1316

Health conditions studied

1

Description of health condition studied
End Stage Renal Disease
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease

Primary outcomes

1

Description
Systolic blood pressure
Timepoint
First visit to the operating room, after the induction, after intubation, before the injection into the abdominal cavity, after the injection of the gas into the abdominal cavity and then in the recovery room
Method of measurement
Invasive blood pressure monitor

2

Description
Diastolic blood pressure
Timepoint
First visit to the operating room, after the induction, after intubation, before the injection into the abdominal cavity, after the injection of the gas into the abdominal cavity and then in the recovery room
Method of measurement
Invasive blood pressure monitor

3

Description
Mean arterial blood pressure
Timepoint
First visit to the operating room, after the induction, after intubation, before the injection into the abdominal cavity, after the injection of the gas into the abdominal cavity and then in the recovery room
Method of measurement
Invasive blood pressure monitor

Secondary outcomes

1

Description
Heart rate per minute
Timepoint
First visit to the operating room, after the induction, after intubation, before the injection into the abdominal cavity, after the injection of the gas into the abdominal cavity and then in the recovery room
Method of measurement
Manitor

Intervention groups

1

Description
Control group: In the complete intravenous anesthetic group, for induction, Etomidate 3.0 mg/kg is used. For maintenance of anesthesia, Etomidate 100 mg/kg for the first 10 minutes after induction and followed by 20 mg/kg for up to 10 minutes until the end of the surgery is used.
Category
Other

2

Description
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.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital of Tehran University of Medical Sciences
Full name of responsible person
Mojgan Rahimi
Street address
Imam Khomeini Hospital, Keshavarz Blv
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Yunesian
Street address
Tehran University of Medical Sciences, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Razieh Erfani
Position
Student, Anesthesiology Assistant
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Keshavarz Blvd
City
Tehran
Postal code
Phone
+91 55617968
Fax
Email
razierfani@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mojgan Rahimi
Position
Faculty member/Anesthesiologist
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Keshavarz Blvd
City
Tehran
Postal code
Phone
00
Fax
Email
mrahimi@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Razieh Erfani
Position
Anesthesiology Assistant
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Keshavarz Blvd
City
Tehran
Postal code
Phone
00
Fax
Email
razierfani@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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