Evaluation of monitoring of depth of anesthesia using bispectral index and clinical standard method in recovery of patients after gynecologic laparoscopic surgery
Objectives: Monitoring the depth of anesthesia by using bispectral index and clinical standard method for recovery of patients after laparoscopic surgical in women.
Design: Block randomization, triple blind, without placebo, single center, trial phase 2, including 80 patients undergoing laparoscopic surgery for women.
Participants including major eligibility criteria: All patients undergoing laparoscopic surgery for women.
Intervention: Intervention 1. Using standard method to measure the patient's consciousness during surgery
Intervention 2. Using bispectral index to measure the patient's consciousness during surgery
Main outcome measures: Time of discharge from recovery, Amount of used narcotics, Pain.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015122919715N2
Registration date:2016-01-12, 1394/10/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-12, 1394/10/22
Registrant information
Name
Arash Pourbakhshandeh
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2326
Email address
alimyan.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences, Vice Chancellor for Research
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of monitoring of depth of anesthesia using bispectral index and clinical standard method in recovery of patients after gynecologic laparoscopic surgery
Public title
Evaluation of depth of anesthesia using two different methods in gynecologic laparoscopic surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age over 18 years; ASA class I-III; patients undergoing laparoscopic surgery for women; no history of chronic obstructive pulmonary disease; lack of kidney dysfunction; lack of neurologic disease; lack of addiction to opium or alcohol; not taking anticonvulsants and antidepressants; Lack of hypertension; lack of heart failure; patients with emergent surgery.
Exclusion criteria: Patients with difficult airway; Drug allergy.
Age
From 18 years old to 70 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Headquarters building, 5th floor, intersection of Sheikh Fazl-Allah Noori and Shahid Chamran, Western Hemmat highway, Tehran, Iran
City
Tehran
Postal code
Approval date
2015-12-02, 1394/09/11
Ethics committee reference number
Ir.iums.rec.13949111174020
Health conditions studied
1
Description of health condition studied
gynecologic surgery
ICD-10 code
O75.4
ICD-10 code description
Other complications of obstetric surgery and procedures
Primary outcomes
1
Description
Time of discharge from recovery
Timepoint
After the end of surgery
Method of measurement
Aldrete score
2
Description
Amount of used narcotics
Timepoint
Within the surgery
Method of measurement
Quantitative
3
Description
Pain
Timepoint
Within the surgery
Method of measurement
Visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention 1. Using standard method including blood pressure and pulse rate to measure the patient's consciousness during surgery
Category
Prevention
2
Description
Intervention 2. Using bispectral index to measure the patient's consciousness during surgery