Protocol summary

Study aim
The effect of ephedrine, ketamine, ondansetron and atropine on nausea and vomiting during and after surgery under spinal anesthesia.
Design
Clinical trial, with parallel groups, double-blind, randomized, phase 2-3 on 128 patients, the patients were randomized based on the block random pattern.
Settings and conduct
Patients are hospitalized for at least one day before surgery and will fast for 8 hours. Upon entering the operating room, an intravenous line is established for the patient and through it they receive 10 ml per kg of Ringer's serum. Before the spinal anesthesia, the patients will receive 4 groups of medicine. In order to equalize the volume of intervention medicine in all groups, after calculating the desired dose, it will be brought to 5 ml with distilled water and administered intravenously. The frequency and severity of nausea and vomiting, the degree of sedation and the amount of metoclopyramide will be recorded by the student. The study will be designed in a double-blind manner.The patient, the data recorder, and the analyst will not know about the grouping.
Participants/Inclusion and exclusion criteria
Inclusion cditeria: age 18-75 years ohd; both genders; ASA class 1 and 2; lower limb fracture repair surgery under spinal anesthesia. Failure to enter: history of drug addiction; history of allergies: neuromuscular diseases: cardiomyopathy: coagulation disease: underlying disease.
Intervention groups
Group 1: 5 mg of ephedrine. Group 2: 100 micrograms of atropine. Group 3: 8 mg of ondansetron. Group 4: Ketamine at the rate of 0.3 mg per kg
Main outcome variables
Vomiting score in recovery, 2, 4, 6, 12, and 24 hours after surgery Occurrence of nausea during recovery, 2, 4, 6, 12, and 24 hours after surgery. Severity of nausea during recovery, 2, 4, 6, 12, and 24 hours after surgery RAMSAY score in recovery and 1, 2 and 4 hours after the operation Taking Metoclopyramide within 24 hours

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230713058769N1
Registration date: 2023-07-29, 1402/05/07
Registration timing: prospective

Last update: 2023-07-29, 1402/05/07
Update count: 0
Registration date
2023-07-29, 1402/05/07
Registrant information
Name
Mohammadreza Hasani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3477 7490
Email address
mohammadrezahasani7899@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of ephedrine, ketamine, ondansetron and atropine drugs to prevent nausea and vomiting during and after surgery in patients under spinal anesthesia for lower limb fracture repair
Public title
Comparison of the effect of ephedrine, ketamine, ondansetron and atropine drugs to prevent nausea and vomiting during and after surgery in patients under spinal anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-75 years old Both genders ASA class 1 and 2 Lower limb fracture repair surgery under spinal anesthesia Consent to participate in the study
Exclusion criteria:
History of drug addiction History of seasonal allergies and allergies to any of the drugs used in this study Presence of neuromuscular diseases Presence of cardiomyopathy Presence of coagulopathy Presence of an underlying disease
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 128
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into 4 groups based on the balanced block randomization pattern and the size of the blocks will be 8. The randomization is done by the consultant professor using the online program at https://www.sealedenvelope.com/. Hiding the random chain is done by the method of opaque envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be designed in a double-blind manner. The method of blinding is that the anesthesiologist prepares the drugs and the anesthetist performs the spinal anesthesia. A student who is responsible for recording information in certain time intervals. Also, the groups are sent to the statistician using coding, and the analyst does not know about the grouping.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Vice chancellor of Research, Prophet Azam University Complex, Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2023-06-27, 1402/04/06
Ethics committee reference number
IR.ARAKMU.REC.1402.087

Health conditions studied

1

Description of health condition studied
Postoperative nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting

Primary outcomes

1

Description
Vomiting score according to the vomiting score table
Timepoint
In recovery, 2, 4, 6, 12 and 24 hours after the operation
Method of measurement
Physical examination

2

Description
Number of times nausea occurs
Timepoint
In recovery, 2, 4, 6, 12 and 24 hours after the operation
Method of measurement
Physical examination

3

Description
Severity of nausea according to visual analogue scale
Timepoint
In recovery, 2, 4, 6, 12 and 24 hours after the operation
Method of measurement
Visual Analogue Scale

Secondary outcomes

1

Description
The degree of sedation according to the RAMSAY SCORE
Timepoint
In recovery and 1, 2 and 4 hours after the operation
Method of measurement
RAMSAY SCORE

2

Description
Dosage of Metoclopramide
Timepoint
Within 24 hours after the operation
Method of measurement
Patient file

Intervention groups

1

Description
Intervention group 1: Before spinal anesthesia, they will receive 5 mg of ephedrine (Sterop belgium pharmaceutical company). In order to equalize the volume of the intervention drug in all groups, after calculating the desired dose, it will be brought to 5 ml with distilled water. And it is administered intravenously.
Category
Treatment - Drugs

2

Description
Intervention group 2: Before spinal anesthesia, they will receive 100 micrograms of atropine (Caspin Pharmaceutical Company, Rasht Supply - Iran). In order to equalize the volume of the intervention drug in all groups, after calculating the desired dose, it will be brought to 5 ml with distilled water. And it is administered intravenously.
Category
Treatment - Drugs

3

Description
Intervention group 3: Before spinal anesthesia, they will receive 8 mg of ondansetron (Alborz Daru Pharmaceutical Company). In order to equalize the volume of the intervention drug in all groups, after calculating the desired dose, it will be brought to 5 ml with distilled water. And it is administered intravenously.
Category
Treatment - Drugs

4

Description
Intervention group 4: Before the spinal anesthesia, they will receive 0.3 mg per kg of ketamine (Exir pharmaceutical company - Iran). In order to equalize the volume of the intervention drug in all groups, after calculating the desired dose, it will be brought to 5 ml with distilled water. And it is administered intravenously.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Dr Hesamoddin Modir
Street address
Valiasr Hospital, Valiasr Square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3223 1283
Email
pr_valieasr@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Davood Hekmat Po
Street address
Vice chancellor of Research, Prophet Azam University Complex, Basij Square
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor of Research of 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 Hesamoddin Modir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr Square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
modir.he@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Hesamoddin Modir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr Square
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
Dr Hesamoddin Modir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr Square
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
modir.he@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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