Preventive effect of intravenous dexamethasone on nausea and vomiting after laparoscopic ovarian cystectomy
Design
A randomized double-blinding clinical trial, with the parallel groups
Settings and conduct
In this study, 88 patients who are candidates for laparoscopic cystectomy will be included in the study and will be randomly divided into two groups. Dexamethasone will be given intravenously in one group and normal saline in the other. Patients' nausea and vomiting are then assessed.
Participants/Inclusion and exclusion criteria
Inclusion criteria are women candidates for laparoscopic cystectomy, with ASA 2 and obtaining informed consent to participate in the study. Exclusion criteria included contraindications to use of dexmetazone, severe and uncontrolled cardiovascular, renal, hepatic, chronic respiratory disease, use of antiemetic and analgesic drugs in the 24 hours before surgery, pregnant or elderly women, people who describe the experience of gastrointestinal problems and postoperative nausea, or a history of corticosteroids, or a body mass index (BMI) of more than 30 kg / m2.
Intervention groups
Two minutes before the induction of anesthesia, the first group received 8 mg of dexamethasone (2 cc) and the second group received normal saline with the same volume (2 cc) intravenously. Then induction of anesthesia is performed with fentanyl 2 μg / kg, propofol 2 mg/kg, atracurium 0.5 mg/kg and ventilation is performed with a mask. Three minutes later, the patient is intubated with a 7.5 intubation tube. Continued anesthesia of the patient during surgery is provided with 0.8% isoflurane and 0.1 mg/kg morphine.
Main outcome variables
Severity of nausea; Severity of vomiting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200825048515N7
Registration date:2020-10-08, 1399/07/17
Registration timing:prospective
Last update:2020-10-08, 1399/07/17
Update count:0
Registration date
2020-10-08, 1399/07/17
Registrant information
Name
Asieh Maghami Mehr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 0000 0000
Email address
asimaghami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-04-19, 1400/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preventive effect of intravenous dexamethasone on nausea, vomiting and pain after laparoscopic ovarian cystectomy
Public title
The effect of intravenous dexamethasone on nausea, vomiting and pain after laparoscopic ovarian cystectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Being candidate for laparoscopic cystectomy
ASA score of 2 according to American Society of Anesthesiologists Classification (ASA class)
Informed consent to participate in the study
Exclusion criteria:
Contraindications to use of dexamethasone
Having severe and uncontrolled diseases of cardiovascular, renal, hepatic, chronic respiratory
Taking anti-nausea drugs and painkillers 24 hours before surgery
People with a history of gastrointestinal problems and postoperative nausea
Having a history of corticosteroids
BMI>30 kg/m2
Pregnant and elderly women
Age
From 18 years old to 65 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
88 eligible patients will be randomly selected. Then, these patients will be randomly encoded using computer software called "Random Allocation" and automatically divided into two groups. The relevant codes will be entered in the raw checklists and each of these checklists will be randomly assigned to one patient and that patient will be randomly assigned to one of the two study groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, dexamethasone and normal saline were pre-prepared by the operating room nurse in one volume and labeled A and B. It is then given daily to the researcher and will be used randomly for patients.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib Ave, Azadi Square.
City
Isfaha
Province
Isfehan
Postal code
8174673461
Approval date
2020-09-26, 1399/07/05
Ethics committee reference number
IR.MUI.MED.REC.1399.528
Health conditions studied
1
Description of health condition studied
Laparoscopic cystectomy
ICD-10 code
N83.2
ICD-10 code description
Other and unspecified ovarian cysts
Primary outcomes
1
Description
Severity of nausea
Timepoint
Zero, 2, 12 and 24 hours after surgery
Method of measurement
Visual Analogue Scale (VAS)
2
Description
Severity of vomiting
Timepoint
Zero, 2, 12 and 24 hours after surgery
Method of measurement
Visual Analogue Scale (VAS)
Secondary outcomes
1
Description
Patient satisfaction
Timepoint
24 hours after surgery
Method of measurement
Score 0 as dissatisfied to score 5 as complete satisfaction
Intervention groups
1
Description
Control group: Patients in this group are given intravenous normal saline with the same volume (two cc) two minutes before induction of anesthesia. Then induction of anesthesia is performed with fentanyl 2 μg / kg, propofol 2 mg / kg and atracurium 0.5 mg / kg and ventilation is performed with a mask. Three minutes later, the patient is intubated with a 7.5 intubation tube. Continued anesthesia of the patient during surgery is provided with 0.8% isoflurane and 0.1 mg / kg morphine.
Category
Placebo
2
Description
Intervention group: Patients in this group are given 8 mg of dexamethasone (2 cc) intravenously two minutes before induction of anesthesia. Then induction of anesthesia is performed with fentanyl 2 μg / kg, propofol 2 mg / kg and atracurium 0.5 mg / kg and ventilation is performed with a mask. Three minutes later, the patient is intubated with a 7.5 intubation tube. Continued anesthesia of the patient during surgery is provided with 0.8% isoflurane and 0.1 mg / kg morphine.