The aim of this study is to evaluate the effect of depth of anesthesia on pain after laparoscopic cholecystectomy. 66 patients undergoing laparoscopic cholesystectomy referred to Hazrat Rasool Akram Hospital as a randomized, double-blind,without controlled with placebo and without a trial phase with using the file number and in parallel are divided into two groups. Patients should be aged between 18 and 65 years and should be have ASA I ir II and patients with operated for more than three hours or conversion to laparotomy laparoscopic surgery were excluded. In the first group, BIS between 35 and 45 (Group L)is maintained and in the second group (Group H) BIS between 45 and 55 is maintained with drug using. At the end of surgery, drug consumption during operation and lenth of opertaion are recorded. The amount of pain of patients is recorded with using of VAS score in recovery and post-operative hours. The need for opioids during 24 hours after operation and the rate of nausea and vomiting after surgery and patient satisfaction also be recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011412642N25
Registration date:2017-01-24, 1395/11/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-24, 1395/11/05
Registrant information
Name
Majid Golestani Eraghi
Name of organization / entity
Shahid Beheshti University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3336 0547
Email address
dr.golestani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of depth of anesthesia on pain after surgery in laparascopic cholesystectomy
Public title
The effect of depth of anesthesia on pain after surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patient candidated for elective laparascopic cholesystectomy; patient with ASA I or II; Lack of malignancy or seizures; Lack of auditory problem; BMI<35; Lack of heart, pulmonary, liver and kidney failure; Lack of uncontrolled systemic disease; Lack of addiction; Lack of chronic pain and/or with any analgesic drug.Exclusion criteria: Prolongation of action for more than three hours; Conversion of laparoscopic surgery to laparotomy; patient death.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
patients with due attention to file number pair and odd, were randomely divided into two groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancellor for research, Iran University of Medical Sciences
Street address
Vice chancellor for research of Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Approval date
2015-06-24, 1394/04/03
Ethics committee reference number
ir.iums.res.1394.9211174020
Health conditions studied
1
Description of health condition studied
general anesthesia
ICD-10 code
Y84
ICD-10 code description
Other medical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure
Primary outcomes
1
Description
Heart rate
Timepoint
during surgery, before and after that
Method of measurement
with pulse oxymeter device and according to beat per minute
2
Description
need to analgesic drug
Timepoint
during 24 hours after surgery
Method of measurement
according to miligeram
3
Description
amount of pain
Timepoint
in recovery and 8,16 and 24hours after surgery
Method of measurement
with using of VAS score
4
Description
systolic and diastolic blood pressure
Timepoint
during surgery, before and after that
Method of measurement
Non-invasive barometer in mm Hg
Secondary outcomes
1
Description
amount of nausea and vomitting
Timepoint
during 24 hours after surgery
Method of measurement
according to severity and score 0 to 3
2
Description
duration of surgery
Timepoint
from start of surgery to start of recovery
Method of measurement
according to minute
Intervention groups
1
Description
In the first group (L group) after induction of anesthesia, anesthesia in order to maintain BIS between 35 and 45, propofol with dose of 75 to 150 micrograms per kilogram of body weight and remifentanil with dose of 0.1 to 0.3 micrograms per kilogram of body weight are used
Category
Prevention
2
Description
In the first group (H group) after induction of anesthesia, anesthesia in order to maintain BIS between 35 and 45, propofol with dose of 75 to 150 micrograms per kilogram of body weight and remifentanil with dose of 0.1 to 0.3 micrograms per kilogram of body weight are used
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasool Hospital
Full name of responsible person
Poopak Rahimzadeh
Street address
Satarkhan Ave
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Seyed Alijavad Musavi
Street address
Vice chancellor for research of Iran University of Medical Sciences, Hemmat Highway
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, Iran 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
Anesthesiology group of Iran University of Medical Science
Full name of responsible person
Poopak Rahimzadeh
Position
Fellowship in pain
Other areas of specialty/work
Street address
Hazrat Rasool Hospital, Satarkhan Ave
City
Tehran
Postal code
Phone
+98 21 6651 5001
Fax
Email
p-rahimzadeh@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Anesthesiology group of Iran University of Medical Science
Full name of responsible person
Poopak Rahimzadeh
Position
Fellowship in pain
Other areas of specialty/work
Street address
Hazrat Rasool Hospital, Satarkhan Ave
City
Tehran
Postal code
Phone
+98 21 6651 5001
Fax
Email
p-rahimzadeh@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Anesthesiology group of Iran University of Medical Science
Full name of responsible person
Poopak Rahimzadeh
Position
Fellowship of pain
Other areas of specialty/work
Street address
Hazrat Rasool Hospital, Satarkhan Ave
City
Tehran
Postal code
Phone
+98 21 6651 5001
Fax
Email
research@iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)