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Comparison of droperidol and granisetron with dexamethasone and granisetron in the control of postoperative nausea and vomiting (PONV) in laparoscopic cholecystectomy

Protocol summary

Study aim
Comparison of droperidol and granisetron with dexamethasone and granisetron in the control of postoperative nausea and vomiting in laparoscopic cholecystectomy
Design
The study will be double blind and clinical trial.120 patients will be randomly divide into 3 groups. The groups are parallel. The trial phase is 3.
Settings and conduct
Patients undergoing laparoscopic cholecystectomy at Vali-e-Asr Hospital in Arak will be randomly allocated into 3 groups using simple randomization with an envelope system. This is a double-blind study, ensuring blinding of the outcome assessor, data analyst, and participants.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:patients scheduled for laparoscopic cholecystectomy surgery, patients classified as ASA I or II, absence of renal, hepatic, or cardiovascular diseases,no history of drug abuse, alcohol consumption, or chronic use of analgesics, no history of malignancy, no history of psychiatric or psychotic disorders Exclusion Criteria: withdrawal of consent to continue participation in the study, possible death of the patient during the study
Intervention groups
Granisetron and Droperidol Group: Patients will receive Granisetron (Caspian Tamin Rasht Pharmaceutical Company – Iran) at a dose of 20 micrograms per kilogram and 1.25 mg of Droperidol (Panpharma Pharmaceutical Company – France), both administered intravenously. Granisetron and Dexamethasone Group:Patients will receive Granisetron (Caspian Tamin Rasht Pharmaceutical Company – Iran) at a dose of 20 micrograms per kilogram and 8 mg of Dexamethasone (Caspian Tamin Rasht Pharmaceutical Company – Iran). Granisetron and Saline Group: Patients will receive Granisetron (Caspian Tamin Rasht Pharmaceutical Company – Iran) at a dose of 20 micrograms per kilogram along with normal saline.
Main outcome variables
Nausea, vomiting, sedation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141209020258N202
Registration date: 2026-04-25, 1405/02/05
Registration timing: registered_while_recruiting

Last update: 2026-04-25, 1405/02/05
Update count: 0
Registration date
2026-04-25, 1405/02/05
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-04-19, 1405/01/30
Expected recruitment end date
2027-04-19, 1406/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of droperidol and granisetron with dexamethasone and granisetron in the control of postoperative nausea and vomiting (PONV) in laparoscopic cholecystectomy
Public title
Comparison of droperidol and granisetron with dexamethasone and granisetron in the control of postoperative nausea and vomiting (PONV) in laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidates for laparoscopic cholecystectomy ASA class I or II both of gender Having informed consent to participate in the study Patients with no history of renal, hepatic, or cardiovascular disease Absence of any history of drug abuse, alcohol use, or chronic analgesic consumption Absence of a history of malignancy No history of hypertension, diabetes, or hematologic/vascular disorders No history of psychiatric or psychotic disorders No history of Parkinson’s disease, movement disorders, or chemotherapy No known sensitivity to study medications and no seasonal allergies All patients undergoing general anesthesia Surgery performed by a surgeon Surgical duration ranging from 60 to 150 minutes
Exclusion criteria:
Lack of consent to continue participation in the study Possible death of the patient
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated into 3 groups using a permuted balanced block randomization method with the size of blocks 6. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be established as a double-blind trial. None of the patients will be aware of the type of medication they are receiving. These medications will be administered to the patients by the anesthesiologist. Each medication will be drawn into a separate syringe, which will be covered with a label, and its contents will not be identifiable. Furthermore, the medications in each syringe will be coded, and only the primary supervisor, who is an anesthesiologist, will know their contents. The intern responsible for recording outcomes will not be aware of the patient grouping or the coding system. Patients will be assessed based on their medical record number, and the collected data will be handed over to the attending physician
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics comittee of Arak University of Medical Sciences
Street address
Ethics comittee, Research center, Payambar Azam complex, Basij squre ,Sardasht,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2026-04-12, 1405/01/23
Ethics committee reference number
IR.ARAKMU.REC.1405.034

Health conditions studied

1

Description of health condition studied
Cholecystectomy surgery
ICD-10 code
K91.86
ICD-10 code description
Retained cholelithiasis following cholecystectomy

Primary outcomes

1

Description
Incidence of nausea
Timepoint
Recovery and 2, 4, 6, 12 and 24 hours after surgery
Method of measurement
Score 0 to 10

2

Description
Vomiting
Timepoint
Recovery and 2, 4, 6, 12 and 24 hours after surgery
Method of measurement
Score 0 to 4

3

Description
Sedation
Timepoint
Recovery and 2, 4, 6, 12 and 24 hours after surgery
Method of measurement
Ramsay score

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Patients will receive Granisetron (Caspian Tamin Rasht Pharmaceutical Company – Iran) at a dose of 20 micrograms per kilogram and 1.25 mg of Droperidol (Panpharma Pharmaceutical Company – France), both administered intravenously.
Category
Treatment - Drugs

2

Description
Intervention group 2: Patients will receive Granisetron (Caspian Tamin Rasht Pharmaceutical Company – Iran) at a dose of 20 micrograms per kilogram and 8 mg of Dexamethasone (Caspian Tamin Rasht Pharmaceutical Company – Iran).
Category
Treatment - Drugs

3

Description
Intervention group 3: Patients will receive Granisetron (Caspian Tamin Rasht Pharmaceutical Company – Iran) at a dose of 20 micrograms per kilogram along with normal saline.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Hesamodin Modir
Street address
Valiasr hospital, Valiasr squre
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Email
modir.he@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Arak University Of Medical Sciences
Full name of responsible person
Dr Behzad Khansarinejad
Street address
Research Center, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
khansarinejad@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Sosanabadi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr Squre, Shahid Shirodi Street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
sosanabadi@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Hesamedin Modir
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
modir.he@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hesamodin Shams
Position
medicine student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Vice chancellor for research, Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
drhesamshams@gmail.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
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