Comparison of hemodynamic and antiemetic effects of midazolam combination with three drugs , ephedrine, dexamethasone and dexmedetomidine in patients undergoing laparoscopic cholecystectomy
Comparison of hemodynamic and antiemetic effects of midazolam combination with three drugs , ephedrine, dexamethasone and dexmedetomidine in patients undergoing laparoscopic cholecystectomy
Design
The study of the two-course clinical trial of 96 patients was randomly divided into 4 groups. The groups are parallel. The trial phase is 3.
Settings and conduct
Candidates for laparoscopic cholecystectomy in Valiasr Hospital in Arak are divided into 3 groups by simple randomization with envelopes. The study is double-blind in which outcome evaluator and data analyst and participant are kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Candidate patients for laparoscopic cholecystectomy, ASA class 1 and 2 , no history of mental illness and psychosis, no Parkinson's disease, motion sickness or history of chemotherapy, patients under general anesthesia, duration of surgery 60 to 150 minutes, lack of sensitivity to the drugs used, no hypertension and no vascular problems
Exclusion criteria: patients without conscious consent, death of the patient
Intervention groups
Intervention group 1: 0.5 mg / kg ephedrine will be prescribed. (Made by Biotica Pharmaceutical Company)
Intervention group 2: 0.05 mg / kg dexamethasone will be prescribed. (Caspian Tamin Company, Rasht - Iran)
Intervention group 3: 1 mcg / kg dexmedetomidin will be prescribed. (Exir - Iran)
Main outcome variables
Nausea, vomiting, sedation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N151
Registration date:2021-02-21, 1399/12/03
Registration timing:prospective
Last update:2021-02-21, 1399/12/03
Update count:0
Registration date
2021-02-21, 1399/12/03
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
Recruitment complete
Funding source
Expected recruitment start date
2021-03-05, 1399/12/15
Expected recruitment end date
2022-03-06, 1400/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of hemodynamic and antiemetic effects of midazolam combination with three drugs , ephedrine, dexamethasone and dexmedetomidine in patients undergoing laparoscopic cholecystectomy
Public title
Comparison of hemodynamic and antiemetic effects of midazolam combination with three drugs , ephedrine, dexamethasone and dexmedetomidine in patients undergoing laparoscopic cholecystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate patients for laparoscopic cholecystectomy
ASA class 1 and 2
No history of mental illness and psychosis
No Parkinson's disease, motion sickness or history of chemotherapy
Patients under general anesthesia
Duration of surgery 60 to 150 minutes
Lack of sensitivity to the drugs used
No hypertension and no vascular problems
Exclusion criteria:
Patients without conscious consent
Death of the patient
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with random allocation with envelopes in 2 groups A and B and C. In this method, we selected a number of cards or letters as an intervention group and the same number of cards for the control group, then the cards were merged. One card was taken out and its allocation was registered and the card was returned to the other cards after leaving. Then the cards are merged again and we remove another card. This process continues to reach a random sequence according to sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is clinical trial.Outcome elevator and analyzer and participant are blind (double blind).Outcome elevator and analyzer and participant don't aware from grouping.
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
2021-01-24, 1399/11/05
Ethics committee reference number
IR.ARAKMU.REC.1399.311
Health conditions studied
1
Description of health condition studied
cholecystectomy
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
Observation
2
Description
Vomiting
Timepoint
Up to 24 hours after surgery
Method of measurement
Score 0 to 4
3
Description
Severe nausea
Timepoint
Up to 24 hours after surgery
Method of measurement
Visual analog scale
4
Description
Sedation
Timepoint
In recovery and 1, 2 and 4 hours after surgery
Method of measurement
Ramsay score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: 0.5 mg / kg ephedrine will be prescribed. (Made by Biotica Pharmaceutical Company)
Category
Treatment - Drugs
2
Description
Intervention group 2: 0.05 mg / kg dexamethasone will be prescribed. (Caspian Tamin Company, Rasht - Iran)
Category
Treatment - Drugs
3
Description
Intervention group 3: 1 mcg / kg dexmedetomidin will be prescribed. (Exir - Iran)
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
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
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
alikamaliir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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 Hesamedin Modir
Position
Associate 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 scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Hesamedin Modir
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Valiasr Hospital, Valiasr squre, Shahid Shirodi street