Protocol summary
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Study aim
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Comparison of prevalence of nausea and vomiting after laparascopic cholecystectomy in case of pretreatment with Haloperidol and Ondansetron
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Design
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Double blinded randomized clinical trial
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Post-operative Nausea and Vomiting, Length of stay in the recovery room and the discharge time from recovery room
General information
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Reason for update
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Due to several refereeing corrections at the time of registration, the expected recruitment start date has not been corrected in the last refereeing. Please, change expected recruitment start date six days later.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20141009019470N85
Registration date:
2019-08-07, 1398/05/16
Registration timing:
registered_while_recruiting
Last update:
2021-02-15, 1399/11/27
Update count:
1
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Registration date
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2019-08-07, 1398/05/16
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-08-07, 1398/05/16
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Expected recruitment end date
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2019-10-03, 1398/07/11
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of prevalence of nausea and vomiting after laparascopic cholecystectomy in case of pretreatment with Haloperidol and Ondansetron
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Public title
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Comparison of prevalence of nausea and vomiting after laparascopic cholecystectomy in case of pretreatment with Haloperidol and Ondansetron
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-04-15, 1397/01/26
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Ethics committee reference number
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IR.SUMS.MED.REC.1396.128
Health conditions studied
1
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Description of health condition studied
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Laparoscopy Cholecystectomy
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ICD-10 code
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K80.1
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ICD-10 code description
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Calculus of gallbladder with other cholecystitis
Primary outcomes
1
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Description
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Post-operative Nausea and Vomiting
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Timepoint
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Every 15 min at the recovery room and every 1 hour at the ward
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Method of measurement
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Bellville Scoring
Secondary outcomes
1
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Description
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Length of stay in the recovery room and the discharge time from recovery room
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Timepoint
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Every 15 min at the recovery room
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Method of measurement
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Aldrete Score
2
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Description
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Patients’ Satisfaction
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Timepoint
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At the end of the trial
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Method of measurement
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Likert scoring
Intervention groups
1
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Description
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Intervention group: patients in the group one received 0.05 mg/kg IV. Haloperidol during 5 min after induction of anesthesia
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Category
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Prevention
2
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Description
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Intervention group: patients in the group two received 0.15 mg/kg IV. Ondansetrone after induction of anesthesia
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available