Comparison of prevalence of nausea and vomiting after laparascopic cholecystectomy in case of pretreatment with Haloperidol and Ondansetron
Design
Double blinded randomized clinical trial
Settings and conduct
Intervention group: patients in the group one received 0.05 mg/kg IV. Haloperidol during 5 min after induction of anesthesia.
Intervention group: patients in the group two received 0.15 mg/kg IV. Ondansetrone after induction of anesthesia.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18--60 years old Patients undergoing laparoscopy cholecystectomy under general anesthesia Cholelithiasis Chronic cholecystitis Cholecystic polyp ASA I-II.
Exclusion Criteria:Underlying medical condition that is currently not under control History of allergy to drugs or use of alcohol; Parkinson History of glaucoma Bone marrow depression Severe liver disease Obstructive bowel disease History of prostate disease History of cardiac arrhythmia History of respiratory failure or respiratory distress Taking antidepressants History of allergy to haloperidol or ondansetron Pregnancy Breast feeding patients Digestive diseases, kidney and hematology History of dizziness or motion Use an anti-nausea and vomiting agent within 24 hours before the surgery Anxiety disorders,Restlessness, loss in time and place Confusion, tremor, chills, seizure, tinnitus History of Bradycardia Reduced cardiac function Low blood pressure Surgery takes more than an hour. Opium addiction.
Intervention groups
Intervention group: patients in the group one received 0.05 mg/kg IV. Haloperidol during 5 min after induction of anesthesia.
Intervention group: patients in the group two received 0.15 mg/kg IV. Ondansetrone after induction of anesthesia.
Main outcome variables
Post-operative Nausea and Vomiting, Length of stay in the recovery room and the discharge time from recovery room
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141009019470N85
Registration date:2019-08-07, 1398/05/16
Registration timing:registered_while_recruiting
Last update:2019-08-07, 1398/05/16
Update count:1
Registration date
2019-08-07, 1398/05/16
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-02, 1398/05/11
Expected recruitment end date
2019-10-03, 1398/07/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of prevalence of nausea and vomiting after laparascopic cholecystectomy in case of pretreatment with Haloperidol and Ondansetron
Public title
Comparison of prevalence of nausea and vomiting after laparascopic cholecystectomy in case of pretreatment with Haloperidol and Ondansetron
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18--60 years old
Patients undergoing laparoscopy cholecystectomy under general anesthesia
Cholelithiasis
Chronic cholecystitis
Cholecystic polyp
ASA I-II
Exclusion criteria:
Underlying medical condition that is currently not under control
History of allergy to drugs or use of alcohol;
Parkinson
History of glaucoma
Bone marrow depression
Severe liver disease
Obstructive bowel disease
History of prostate disease
History of cardiac arrhythmia
History of respiratory failure or respiratory distress
Taking antidepressants
History of allergy to haloperidol or ondansetron
Pregnancy
Breast feeding patients
Digestive diseases, kidney and hematology
History of dizziness or motion
Use an anti-nausea and vomiting agent within 24 hours before the surgery
Anxiety disorders,Restlessness, loss in time and place
Confusion, tremor, chills, seizure, tinnitus
History of Bradycardia
Reduced cardiac function
Low blood pressure
Surgery takes more than an hour.
Opium addiction
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was performed based on the 6-point perturbation block method from the Randomization.org site and the patients were divided into two groups, one and two.
Blinding (investigator's opinion)
Double blinded
Blinding description
Syringes containing Haloperidol and Ondonestrone will be prepared by an anesthetic expert who are not aware of the study according to the randomized list .Syringes are marked with the letters A, B, respectively, and the volume of the syringe containing both drugs is achieved by the same amount of normal saline (5 cc) .Patient, anesthesiologist and research specialist have been blinded to data collection.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2018-04-15, 1397/01/26
Ethics committee reference number
IR.SUMS.MED.REC.1396.128
Health conditions studied
1
Description of health condition studied
Laparoscopy Cholecystectomy
ICD-10 code
K80.1
ICD-10 code description
Calculus of gallbladder with other cholecystitis
Primary outcomes
1
Description
Post-operative Nausea and Vomiting
Timepoint
Every 15 min at the recovery room and every 1 hour at the ward
Method of measurement
Bellville Scoring
Secondary outcomes
1
Description
Length of stay in the recovery room and the discharge time from recovery room
Timepoint
Every 15 min at the recovery room
Method of measurement
Aldrete Score
2
Description
Patients’ Satisfaction
Timepoint
At the end of the trial
Method of measurement
Likert scoring
Intervention groups
1
Description
Intervention group: patients in the group one received 0.05 mg/kg IV. Haloperidol during 5 min after induction of anesthesia
Category
Prevention
2
Description
Intervention group: patients in the group two received 0.15 mg/kg IV. Ondansetrone after induction of anesthesia
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Faghihi Hospital
Full name of responsible person
Elisa Ramedani
Street address
Zand Street, Faghihi Hospital
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
Darman@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
sacrc@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
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
Shiraz University of Medical Sciences
Full name of responsible person
Elisa Ramedani
Position
Physician/anesthesiology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
ramedani1363@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ali Karami
Position
Cardio-anesthesiologist
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
alk1380@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
BS in anesthesia/English Consultant
Latest degree
Master
Other areas of specialty/work
Anesthesiology
Street address
5th floor, Mohammad Rasoul Allah Research Tower, Khalili Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
masihifarzaneh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available