The Comparison of two combination of dexamethasone and ondansetron with dexamethasone and plasil on Nausea, vomiting and chills in patients undergoing laparoscopic cholecystectomy
This study is a double-blind randomized clinical trial, on 100 patients, with the aim of survey two combination of dexamethasone and ondansetron with dexamethasone and Plasil on nausea and vomiting, shivering in patients undergoing laparoscopic cholecystectomy will be done. Inclusion criteria including Biliary colic pain and Having indication to laparoscopy cholecystectomy and exclusion criteria included conversion to open Cholecystectomy and complicated cholecystitis. Patients randomly with using random numbers table will be divided into two groups of 50 Patients to the first group 8mg IV dexamethasone+ ondansetron and to second group 8mg dexamethasone+ 10mg plazil will be injected. Anesthesia and drugs used for anesthesia will be the same for both groups. After end of surgery, unaware questioner will be question from patient up to 24 hours after operation (at 1,6,12 and 24 hours) about primary outcome chills, nausea, vomiting and Secondary outcomes that is including dizziness and headaches and answers to the questionnaire will be recorded. The nausea and vomiting patients be evaluated through a N & V scoring. Chills will be graded score of 0-4.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017010923559N7
Registration date:2017-03-20, 1395/12/30
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-03-20, 1395/12/30
Registrant information
Name
Somaieh Matin
Name of organization / entity
Ardabil University of Medicine Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3373 3011
Email address
s.matin@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, َArdabil University of Medical Sciences
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2017-09-22, 1396/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of two combination of dexamethasone and ondansetron with dexamethasone and plasil on Nausea, vomiting and chills in patients undergoing laparoscopic cholecystectomy
Public title
The Comparison of two combination of dexamethasone and ondansetron with dexamethasone and plasil on Nausea, vomiting and chills
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Biliary colic pain, Uncomplicated gallstone, Consent to participate in the study.
Exclusion criteria: Medical complications, sensitivity to dexamethasone, ondansetron and Plazil, complicated cholecystectomy, Open surgery is indicated for gallstones, lack of consent to participate in the study.
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:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study is double-blind. In this study, we have 2 types of envelopes. Envelopes A is containing dexamethasone and ondansetron and Envelopes B which contains dexamethasone and Plazil. Patients by executing and by table of random numbers divided into two A & B groups. According to Patient group, Envelopes For drugs injection will be delivered to anesthesia technician. Anesthesia technician does not know the type of injected drug.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Sciences
Street address
Daneshgah Ave, َArdabil University of Medical Sciences.
City
Ardabil
Postal code
5618985991
Approval date
2016-10-11, 1395/07/20
Ethics committee reference number
IR.ARUMS.REC.1395.52
Health conditions studied
1
Description of health condition studied
Cholecystectomy
ICD-10 code
K80.0
ICD-10 code description
Calculus of gallbladder with acute cholecystitis
Primary outcomes
1
Description
Nausea
Timepoint
Within 24 hours of operation
Method of measurement
Through a score of N & V.
2
Description
Vomit
Timepoint
Within 24 hours of operation
Method of measurement
Through a score of N & V.
3
Description
shivering
Timepoint
Within 24 hours of operation
Method of measurement
shivering visual scale
Secondary outcomes
1
Description
Dizziness
Timepoint
Within 24 hours of operation
Method of measurement
question of patient
2
Description
Headache
Timepoint
Within 24 hours of operation
Method of measurement
MDAS questionnaire
Intervention groups
1
Description
The first group received Intravenous dexamethasone (8 mg) and Intravenous ondansetron during surgery.
Category
Prevention
2
Description
The second group received Intravenous dexamethasone (8 mg) and Intravenous Plasil (10 mg) during surgery.