Evaluation of quality of recovery after general anesthesia by comparison between Isoflurane inhaled anesthetic and propofol intravenous anesthetic for abdominal hysterectomy
Design
80 female patients 30 to 65 years old based on randomized block and 20 blocks separated in 2 groups. Two arm parallel groups randomized trial with single blind,phase 3 will be done.
Settings and conduct
80 female patients candidate for abdominal hysterectomy referred to hospitals of Babol university; selected based on inclusion and exclusion criteria, divided according to randomized approach into two groups recieving Propofol or Isoflurane
Participants/Inclusion and exclusion criteria
Inclusion of females 30- 65 years old with American Society Anesthesiologist(ASA) class 1 and 2
Exclusion of patients with Body Mass Index
(BMI) more than 30 kg/m2 /Difficult airway/Psychotic disorders
Intervention groups
In one group patients receive inhaled Isoflurane and another group receive intravenous Propofol
Main outcome variables
quality of recovery,post operative pain,post operative nausea and vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110409006148N5
Registration date:2020-07-12, 1399/04/22
Registration timing:registered_while_recruiting
Last update:2020-07-12, 1399/04/22
Update count:0
Registration date
2020-07-12, 1399/04/22
Registrant information
Name
Hakimeh Alreza Amiri
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1223 8296
Email address
halereza@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of quality of recovery after general anesthesia with isoflurane compared with propofol in abdominal hysterectomy
Public title
Evaluation of quality of recovery after general anesthesia with isoflurane compared with propofol in abdominal hysterectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
80 female patients 30 to 65 years old with 1 and 2 stages of health based on American Society of Anesthesiologists(ASA) who are candidates for abdominal hysterectomy
Exclusion criteria:
Body Mass Index more than 30 kg/m2
Difficult airway
Psychotic disorders
Age
From 30 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized block/block size 4/20 blocks divided in two groups(Propofol- Isoflurane)
Blinding (investigator's opinion)
Single blinded
Blinding description
80 patients eligible for abdominal hysterectomy based on randomized to two arms for receiving anesthetic drugs .
In one arm patients receive propofol and in the other arm they receive isoflurane
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Science
24 hours before surgery-24 hours after surgery-48 hours after surgery
Method of measurement
Questionnaire of quality of recovery-15
2
Description
Post operative pain
Timepoint
24 hours before surgery-24 hours after surgery-48 hours after surgery
Method of measurement
Questionnaire of quality of recovery-15
3
Description
Nausea and vomiting
Timepoint
24 hours before surgery-24 hours after surgery-48 hours after surgery
Method of measurement
Questionnaire of quality of recovery-15
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 40 patients receive intravenous Propofol with induction dose of 2 mg/kg and 100 mcg/kg/min as an infusion dose produced by darmanyab pharmaceutical factory
Category
Treatment - Drugs
2
Description
Control group: 40 patients receive intravenous Propofol with induction dose of 2 mg/kg and volatile Isoflurane with 1 MAC as an infusion dose produced by BAXTER Co.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rohani hospital
Full name of responsible person
Seyedeh Golnaz Ziaei
Street address
Rohani hospital, Keshavarz avenue, University Square, Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3223 8301
Email
ziaeigolnaz@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr. Reza Ghadimi
Street address
Babol university of medical science,Ganjafrooz avenue, Babol, Mazandaran, Iran
City
Babol
Province
Mazandaran
Postal code
4717647754
Phone
+98 11 3219 7667
Fax
+98 11 3219 0181
Email
rezaghadimi@yahoo.com
Web page address
http://www.mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?