In this study, we’ve compared the effect of dexmedetomidine and remifentanil in Postoperative nausea and vomiting after laparoscopic bariatric surgery.
Design
double-blind and randomized clinical trial
Settings and conduct
Eligible Patients are randomly divided into two groups for Anesthetizing. Anesthesia induction for all patients will be applied by propofol, sufentanil, atracurium, lidocaine, dexamethasone. For maintaining anesthesia, patients are divided into two groups, A and B. each patient of one group receives a dosage of 0.1 μg per kilogram per hour plus propofol. Patients of another group receive Remifentanil 0.2 micrograms per kilogram per hour plus propofol.
The secretary uses a check list, marked with the letter "A" or "B" on the patient's file and occasionally update it. However, the patient and the researcher are not aware of the prescribed medicine for the patient. only the secretary is aware of the prescribed medicine for each group. Then, PONV and the need to anti-nausea medicine are measured at 2, 4, 12, and 24 hours after the surgery. The selection for checking and examination time is based on the half-life of the medicines.
.
Participants/Inclusion and exclusion criteria
femails18-5- yaers candidate for bariatric surgery< nonsmoker
Intervention groups
Eligible Patients are randomly divided into two groups for Anesthetizing. For maintaining anesthesia, patients are divided into two groups, A and B. each patient of one group receives a dosage of 0.1 μg per kilogram per hour plus propofol. Patients of another group receive Remifentanil 0.2 micrograms per kilogram per hour plus propofol.
Main outcome variables
Postoperative nausea and vomiting (PONV)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160903029656N2
Registration date:2019-10-01, 1398/07/09
Registration timing:retrospective
Last update:2019-10-01, 1398/07/09
Update count:0
Registration date
2019-10-01, 1398/07/09
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44147550
Email address
p.delavar@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-06-21, 1397/03/31
Actual recruitment start date
2018-01-21, 1396/11/01
Actual recruitment end date
2018-07-22, 1397/04/31
Trial completion date
2018-07-22, 1397/04/31
Scientific title
investigating the effect of dexmedetomidine and remifentanil on Postoperative nausea and vomiting after laparoscopic bariatric surgery.
Public title
investigating the effect of dexmedetomidine and remifentanil on Postoperative nausea and vomiting after laparoscopic bariatric surgery.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
female
18-50 y
undergoing Bariatric Surgery
Exclusion criteria:
Smoking
having motion sickness
having surgical complications
having the experience of an operation with a duration of one and a half hours or more
Age
From 18 years old to 50 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
150
Actual sample size reached:
174
Randomization (investigator's opinion)
Randomized
Randomization description
The target population of obese patients referred to Shahid Mostafa Khomeini Hospital in Tehran, who underwent laparoscopic obesity surgery during 6 months. Of the obesity surgeries performed during this period, which was approximately 400 cases, according to the Kakarn Table, the sample size was estimated at 174.86 patients were in intervention group A and 86 patients in group B received anesthetic drug based on random numbers table.
Blinding (investigator's opinion)
Double blinded
Blinding description
After obtaining consent from the patient and entering to the operating room Patients are randomly assigned to Group A or B the secretary will mark the type of medicine used in the checklist in Group A and B patient and researcher evaluating postoperative nausea and vomiting doesn’t have information about the drug used in the groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahed University
Street address
Shahid Mostafa Khomeini Hospital, Italia St, Felestin Sq
City
Tehran
Province
Tehran
Postal code
1416643491
Approval date
2018-01-15, 1396/10/25
Ethics committee reference number
IR.Shahed.REC.1396.84
Health conditions studied
1
Description of health condition studied
post operative nausea and vomiting after bariatric surgery
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories
Primary outcomes
1
Description
prevalence of post operative nausea and vomiting after laparoscopic bariatric surgery
Timepoint
Evaluation of nausea and vomiting at 2, 4, 6, 12 and 24 hours after surgery
Method of measurement
Completion of checklists based on patient reports
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Dexmedetomedine (alpha 2 agonist) infused at a rate of 1 μg / kg body weight per hour during maintenance of anesthesia (60 to 90 minutes), vial 200 μg Precedex made in Germany
Category
Treatment - Drugs
2
Description
Control group: Routine infusion of Remifentanil (opioid), 2 μg / kg body weight during maintenance of anesthesia (60 to 90 minutes), 1 g vial made in Spain
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mostafa Khomeini Hospital
Full name of responsible person
Delavar Parvin
Street address
Italia st., Felestin sq.
City
Tehran
Province
Tehran
Postal code
1416643491
Phone
+98 21 8895 6905
Fax
+98 21 8896 3739
Email
dr.pdelavar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Zahra Kiasalari
Street address
Italia st., Felestin sq.
City
Tehran
Province
Tehran
Postal code
1416643491
Phone
+98 21 8895 6905
Fax
+98 21 8896 3739
Email
dr.pdelavar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Delavar Parvin
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Italia st., Felestin sq.
City
Tehran
Province
Tehran
Postal code
1416643491
Phone
+98 21 8895 6905
Fax
+98 21 8896 3739
Email
dr.pdelavar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Delavar Parvin
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Italia st. Felestin sq.
City
Tehran
Province
Tehran
Postal code
1416643491
Phone
+98 21 8895 6905
Fax
+98 21 8896 3739
Email
dr.pdelavar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Delavar Parvin
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Italia st., Felestin sq
City
Tehran
Province
Tehran
Postal code
1416643491
Phone
+98 21 8895 6905
Fax
+98 21 8896 3739
Email
dr.pdelavar@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD